xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05972512</url>
    </required_header>
    <id_info>
      <org_study_id>NB230019-OI</org_study_id>
      <nct_id>NCT05972512</nct_id>
    </id_info>
    <brief_title>A Clinical Study to Assess the Safety and Effectiveness of Plant-based Biotin and Plant Based Biotin With Silica in Healthy Human Subjects With Complaints of Hair Fall, Thin, Dry, &amp; Brittle Hair, and Dry Skin</brief_title>
    <official_title>A Randomized, Double-Blind, Placebo-Controlled, Safety, and Efficacy Study of Plant Based Biotin and Plant Based Biotin With Silica in Healthy Adult Human Subjects With Complaints of Hair Fall Thin, Dry, &amp; Brittle Hair, and Dry Skin</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>NovoBliss Research Pvt Ltd</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Orgenetics, Inc.</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>NovoBliss Research Pvt Ltd</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        A randomized, double-blind, three-arm, placebo-controlled, safety, and efficacy study of&#xD;
        plant-based Biotin and plant-based Biotin with Silica in healthy adult human subjects with&#xD;
        complaints of hair fall, thin, dry, and brittle hair, and dry skin.&#xD;
  &#xD;
        A sufficient number (maximum of 105 (35 subject/test treatment)) of female/male adult&#xD;
        subjects will be recruited/enrolled to ensure a total of 96 subjects (32 subjects/test&#xD;
        treatment) complete the study.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The potential subjects will be screened as per the inclusion &amp; exclusion criteria only after&#xD;
        obtaining written informed consent from the subjects. Total study visits will be 8 during&#xD;
        this study.&#xD;
  &#xD;
        Visit 01 (Within 30 Days): Screening procedure, Informed consent obtain process, baseline&#xD;
        evaluations, blood collection, tattoo on scalp, hair growth rate measurement Visit 02 (Day&#xD;
        01): Enrolments, hair growth rate measurement, other evaluations, product distribution, diary&#xD;
        distribution, AE reporting (if any.&#xD;
  &#xD;
        Visit 03 (Day 27 +2 Days): Treatment period, evaluations, tattoo, hair growth rate&#xD;
        measurement, diary card review, AE reporting (if any).&#xD;
  &#xD;
        Visit 04 (3 Days from Visit 03): Treatment period, evaluations, diary card review, AE&#xD;
        Reporting (if any).&#xD;
  &#xD;
        Visit 05 (Day 57 + 2Days): Treatment period, evaluations, tattoo, hair growth rate&#xD;
        measurement, diary card review, AE Reporting (if any).&#xD;
  &#xD;
        Visit 06 (3 Days from Visit 05): Treatment period, evaluations, diary card review, AE&#xD;
        Reporting (if any).&#xD;
  &#xD;
        Visit 07 (Day 87 +2 Days): Treatment period, evaluations, tattoo, hair growth rate&#xD;
        measurement, diary card review, AE Reporting (if any).&#xD;
  &#xD;
        Visit 08 (3 days from Visit 08): Evaluations, dairy card collection, AE reporting, test&#xD;
        treatments accountability, End of Study process.&#xD;
  &#xD;
        done on Day 04 before Day 01, Day 01 and after test treatment usage will be done on Day 27,&#xD;
        Day 30, Day 57, Day 60, Day 87, Day 90 as listed-below.&#xD;
  &#xD;
          -  60-S Hair Combing Method: Hair Fall.&#xD;
  &#xD;
          -  CASALite Nova (Phototrichogram): Hair Density, Thickness, Hair Growth Rate, Scalp&#xD;
             Condition.&#xD;
  &#xD;
          -  PGA Score: Signs of brittle nails, surface roughness, raggedness and peeling.&#xD;
  &#xD;
          -  Visioscan®VC 20plus (C+K Instrument): Crow's feet area wrinkles, fine lines, skin&#xD;
             texture - roughness, dryness, wrinkles, smoothness (Right cheek).&#xD;
  &#xD;
          -  MoitureMeterEPiD: Skin hydration (Right cheek).&#xD;
  &#xD;
          -  Hair Pull Test: Hair strength.&#xD;
  &#xD;
          -  Pluck Test: A:T ratio (Hair Growth Cycle)&#xD;
  &#xD;
          -  Cutometer: Skin elasticity (Right cheek).&#xD;
  &#xD;
          -  PGA Griffith Scale: Skin dryness, redness, fine wrinkling/lines, coarse wrinkling/lines,&#xD;
             laxity, roughness and sallowness&#xD;
  &#xD;
          -  Tewameter® TM 300: Skin barrier function (Right Cheek)&#xD;
  &#xD;
          -  General Appearance of Hair: Hair shininess, hair reflection, hair plasticity, hair&#xD;
             fizziness, hair volume, hair density Digital photographs: Facial photographs before test&#xD;
             treatment consumption and after test treatment consumption&#xD;
  &#xD;
          -  Blood parameters: CBC, total Serum Cholesterol, Triglyceride, Random Glucose, LDL, HDL&#xD;
             [Note: blood collection will be performed on Day 01 And Day 90]&#xD;
  &#xD;
          -  Blood parameter: HBsAg (Hepatitis B surface antigen) - Screening only&#xD;
  &#xD;
          -  Subjective product perception assessment regarding the test treatment's effect on skin&#xD;
             elasticity, suppleness, skin color, fragrance, taste, skin hydration, skin tone,&#xD;
             firmness, appearance, hair and nails, strongness and shine.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 25, 2023</start_date>
    <completion_date type="Anticipated">December 29, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 29, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>A Randomized, Double-Blind, Placebo-Controlled, Safety, and Efficacy Study</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
      <masking_description>The study is double blind wherein neither the subjects nor the Investigator shall be aware of the test treatment allocation</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Change in hair fall</measure>
      <time_frame>Baseline (Day 01) before dosing to Day 30, Day 60, Day 90 post-dose, between treatments, within treatment and compare with placebo arm</time_frame>
      <description>To assess the effectiveness of test treatment in terms of change in hair fall by using 60-s hair comb test</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in hair thickness (Unit= µm)</measure>
      <time_frame>From baseline (Day 01) before dosing to Day 30, Day 60 and Day 90 post-dose, between treatments, within treatment and compare with placebo arm</time_frame>
      <description>To assess the effectiveness of test treatment in terms of change in hair thickness by CASALite Nova thorough Phototrichogram</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in hair growth rate (Unit= µm)</measure>
      <time_frame>From screening (Within 4 Day) to Day 01, Day 27, Day 30, Day 57, Day 60, Day 87 and Day 90 post-dose, between treatment, within treatment, and compare with placebo arm</time_frame>
      <description>To assess the effectiveness of test treatment in terms of change in hair growth rate by using CASALite Nova thorough Phototrichogram</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in PGA score for sign of brittle nails</measure>
      <time_frame>Baseline (Day 01) before dosing of test treatments to Day 30, Day 60 and Day 90 post-dose, between treatments, within treatment and compare with placebo treated arm</time_frame>
      <description>To assess the effectiveness of test treatment in terms of change in PGA score for sign of brittle nails by using 5-point scoring scale Where 0= None and 5= Severe</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Hair Density (Unit= sqcm)</measure>
      <time_frame>rom baseline (Day 01) before dosing to Day 30, Day 60 and Day 90 post-dose, between treatments, within treatment and compare with placebo arm</time_frame>
      <description>o assess the effectiveness of test treatment in terms of change in hair density by using CASALite Nova thorough phototrichogram</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in PGA score for sign of Nail Surface Roughness</measure>
      <time_frame>From baseline (Day 01) before dosing of test treatments to Day 30, Day 60 and Day 90 post-dose, between treatments, within treatment and compare with placebo treated arm</time_frame>
      <description>To assess the effectiveness of test treatment in terms of change in PGA score for sign of nail surface roughness by using 3 point scoring scale Where 0= None, 3= Severe</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in PGA score for sign of Surface Raggedness</measure>
      <time_frame>From baseline (Day 01) before dosing of test treatments to Day 30, Day 60 and Day 90 post-dose, between treatments, within treatment and compare with placebo treated arm</time_frame>
      <description>To assess the effectiveness of test treatment in terms of change in PGA score for sign of nail surface raggedness by using 3 point scoring scale Where 0= None, 3= Severe</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in PGA score for sign of Peeling</measure>
      <time_frame>From baseline (Day 01) before dosing of test treatments to Day 30, Day 60 and Day 90 post-dose, between treatments, within treatment and compare with placebo treated arm</time_frame>
      <description>To assess the effectiveness of test treatment in terms of change in PGA score for sign of nail surface peeling by using 4 point scoring scale where 0= none, 3= severe</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in facial wrinkle</measure>
      <time_frame>From baseline (Day01) to Day 30, Day 60 and Day 90, between treatments, within treatment and compare with placebo treated arm</time_frame>
      <description>To assess the effectiveness of test treatment in terms of change in facial wrinkles by using Visioscan VC 20plus (Instrumental Evaluation)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in fine lines of crow's feet area,</measure>
      <time_frame>from baseline (Day01) to Day 30, Day 60 and Day 90, between treatments, within treatment and compare with placebo treated arm</time_frame>
      <description>To assess the effectiveness of test treatment in terms of change in fine lines of crow's feet area by using Visioscan VC 20plus (Instrumental Evaluation)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in skin hydration</measure>
      <time_frame>from baseline (Day01) to Day 30, Day 60 and Day 90, between treatments, within treatment and compare with placebo treated arm</time_frame>
      <description>To assess the effectiveness of test treatment in terms of change in skin hydration by using MoistureMeterEpiD (Instrumental Evaluation)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in hair Strength</measure>
      <time_frame>From baseline (Day01) before dosing to Day 30, Day 60 and Day 90 post-dose, between treatments, within treatment and compare with placebo treated arm</time_frame>
      <description>To assess the effectiveness of test treatment in terms of change in hair strength by using hair pull test</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in skin elasticity</measure>
      <time_frame>From baseline (Day01) before dosing to Day 30, Day 60 and Day 90 post-dose, between treatments, within treatment and compare with placebo treated arm</time_frame>
      <description>To assess the effectiveness of test treatment in terms of change in skin elasticity by using Cutometer Dual MPA 580(Instrumental Evaluation)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in PGA Score</measure>
      <time_frame>From baseline (Day01) before dosing to Day 30, Day 60 and Day 90 post-dose, between treatments, within treatment and compare with placebo treated arm</time_frame>
      <description>To assess the effectiveness of test treatment in terms of change in PGA scores i.e. dryness, redness, fine lines, coarse wrinkle, laxity, roughness, and sallowness by using Griffith scale Where 0= No appearance and 9= Severe</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in barrier function of skin</measure>
      <time_frame>From baseline (Day01) before dosing to Day 30, Day 60 and Day 90 post-dose, between treatments, within treatment and compare with placebo treated arm</time_frame>
      <description>To assess the effectiveness of test treatment in terms of change in barrier function of skin by using Tewameter TM Hex(Instrumental Evaluation)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in general appearance of hair</measure>
      <time_frame>From baseline (Day01) before dosing to Day 30, Day 60 and Day 90 post-dose, between treatments, within treatment and compare with placebo treated arm</time_frame>
      <description>To assess the effectiveness of test treatment in terms of change in general appearance of hair such as hair shininess, hair reflection, hair volume, hair density, hair plasticity, hair frizziness by dermatologist trained evaluator</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Anagen: Telogen ratio</measure>
      <time_frame>From baseline (Day01) to Day 90 (+2Days), between treatments, within treatment and compare with placebo treated arm</time_frame>
      <description>To assess the effectiveness of test treatment in terms of change in Anagen: Telogen ratio of hair by using hair pluck test</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in facial photographs(Left/Center/Right)</measure>
      <time_frame>From baseline before usage of test treatments on Day 01, and after usage of test treatments on Day 30, Day 60, Day 90</time_frame>
      <description>Change in facial photographs (Left/Center/Right) of the subject by using Nikol Digital Camera D3300</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Treatment perception questionnaire</measure>
      <time_frame>From before dosing of test treatments to after usage of test treatments on Day 30, Day 60, Day 90</time_frame>
      <description>To assess the effectiveness of test treatment in terms of treatment perception by using 9 point hedonic scale</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Complete Blood Count</measure>
      <time_frame>From Day 01 and Day 90</time_frame>
      <description>Safety of test treatment will be assessed in terms of difference in Complete Blood Count</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in silicon deposits on hair cuticle</measure>
      <time_frame>From baseline (Day01) before dosing to Day 90 post-dose, between treatments, within treatment and compare with placebo treated arm</time_frame>
      <description>To assess the effect of test treatments in terms of change silicon deposits on hair cuticle by using Scanning Electrone Microscope (8 subject/ test treatment)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Skin Texture</measure>
      <time_frame>From baseline (Day01) to Day 30, Day 60 and Day 90, between treatments, within treatment and compare with placebo treated arm</time_frame>
      <description>To assess the effectiveness of test treatment in terms of change in Skin texture by using Visioscan VC 20plus</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Total Serum Cholesterol</measure>
      <time_frame>From Day 01 and Day 90</time_frame>
      <description>Safety of test treatment will be assessed in terms of difference in Total Serum Cholesterol level</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Triglycerides</measure>
      <time_frame>From Day 01 and Day 90</time_frame>
      <description>Safety of test treatment will be assessed in terms of difference in Triglycerides level</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in LDL level</measure>
      <time_frame>From Day 01 and Day 90</time_frame>
      <description>Safety of test treatment will be assessed in terms of difference in LDL level</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in HDL level</measure>
      <time_frame>From Day 01 and Day 90</time_frame>
      <description>Safety of test treatment will be assessed in terms of difference in HDL level</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Random Glucose Level</measure>
      <time_frame>From Day 01 and Day 90</time_frame>
      <description>Safety of test treatment will be assessed in terms of difference in Random Glucose Level</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">105</enrollment>
    <condition>Hair Falling</condition>
    <condition>Thin Hair</condition>
    <condition>Dry Hair</condition>
    <condition>Brittle Hair</condition>
    <condition>Dry Skin</condition>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>The test treatment will be taken two times a day.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Botanical Extract of standardised for biotin (1250 mcg)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The standardised botanical extract of biotin is specially formulated for healthier hair and skin. Biotin promotes the hair growth.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Botanical Extract of standardised for biotin (1250mcg) + 10 mg Silica</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The standardised botanical extract of biotin and silica is specially formulated for healthier hair. The combination of biotin and silica will helpful in hair growth, reduces shedding, and improves the health of hair.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Mode of usage: Two times a day Route of administration: Oral</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Botanical extract of standardized biotin</intervention_name>
      <description>Mode of usage: Two times a day Route of administration: Oral</description>
      <arm_group_label>Botanical Extract of standardised for biotin (1250 mcg)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Botanical extract of standardised biotin with silica</intervention_name>
      <description>Mode of usage: Two times a day Route of administration: Oral</description>
      <arm_group_label>Botanical Extract of standardised for biotin (1250mcg) + 10 mg Silica</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age: 20 to 60 years (both inclusive) at the time of consent&#xD;
  &#xD;
            2. Sex: Healthy males and non-pregnant/non-lactating females.&#xD;
  &#xD;
            3. Subject have complaints of hair fall, thin, dry and brittle hair, and dry skin.&#xD;
  &#xD;
            4. Females of childbearing potential must have a reported negative pregnancy test.&#xD;
  &#xD;
            5. Subject are generally in good health.&#xD;
  &#xD;
            6. Subject must have negative Hepatitis B Surface Antigen Test at baseline.&#xD;
  &#xD;
            7. Subject with self-proclaimed nonpathological thin, dry and brittle hair.&#xD;
  &#xD;
            8. Subject is willing to forgo cosmetic procedures 3 months prior to and for the duration&#xD;
               of the study.&#xD;
  &#xD;
            9. Subject is able to remain on stable doses of contraceptive or replacement hormonal&#xD;
               therapy, including no therapy, 6 weeks prior to and for the duration of the study.&#xD;
  &#xD;
           10. Subject is able to follow their normal skin care routines and to refrain from&#xD;
               introducing any new skin care products during the study.&#xD;
  &#xD;
           11. Subject is able to forgo changes in baseline medications and nutritional supplements&#xD;
               during the study period.&#xD;
  &#xD;
           12. If the subject is of childbearing potential, is practicing and agrees to maintain an&#xD;
               established method of birth control (IUD, hormonal implant device/injection, regular&#xD;
               use of birth control pills or patch, diaphragm, condoms with spermicide or sponge with&#xD;
               spermicidal jelly, cream or foam, partner vasectomy or abstinence). Females will be&#xD;
               considered as non-childbearing potential if they are surgically sterile, have been&#xD;
               post-menopausal for at least 1 year or have had a tubal ligation.&#xD;
  &#xD;
           13. If currently using hormonal contraception, has been using this form of contraception&#xD;
               for at least 6 months and agrees to continue using the same contraception for the&#xD;
               duration of the study.&#xD;
  &#xD;
           14. Subjects are willing not to introduce any new soaps, cleansers, laundry detergents,&#xD;
               lotions, creams, shampoos etc. for the duration of the study.&#xD;
  &#xD;
           15. Subjects are willing to give written informed consent and are willing to follow the&#xD;
               study procedure.&#xD;
  &#xD;
           16. Subjects who have used other marketed products for hair thinning in the past.&#xD;
  &#xD;
           17. Subjects who commit not to use medicated/ prescription shampoos/hair care products&#xD;
               (containing Minoxidil / Anti-thinning agents) or any other hair growth, treatment for&#xD;
               thin hair, or hair products other than the test treatments for the entire duration of&#xD;
               the study.&#xD;
  &#xD;
           18. Willing to use test treatments throughout the study period.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Subjects with a history of hair thinning/hair fall due to any clinically significant&#xD;
               self-reported problems/s like anaemia, thyroid problems, etc.&#xD;
  &#xD;
            2. Subject has a history of allergy or sensitivity to the test treatment ingredients.&#xD;
  &#xD;
            3. Subject has a history of any dermatological condition of the scalp other than hair&#xD;
               loss and/or dandruff or active dermatological condition that might interfere with the&#xD;
               clinical assessments (e.g. tattoos, eczema, psoriasis, acne, etc.).&#xD;
  &#xD;
            4. Subject has used any systemic therapy with chronic antibiotic therapy, retinoids,&#xD;
               and/or oral steroids during the 4 weeks prior to the start or anticipates having to&#xD;
               use at any point during the study.&#xD;
  &#xD;
            5. Subject has applied any topical retinoids within 2 weeks of the screening visit or&#xD;
               anticipates having to use at any point during the study.&#xD;
  &#xD;
            6. Subject is not willing to avoid unprotected sun or other UV radiation exposure during&#xD;
               the study period.&#xD;
  &#xD;
            7. Subject is currently pregnant/breastfeeding.&#xD;
  &#xD;
            8. Subject has a history of prior use of hair growth treatment within 3 months.&#xD;
  &#xD;
            9. Subject has a history of any prior hair growth procedures (e.g., hair transplant or&#xD;
               laser).&#xD;
  &#xD;
           10. Subject has a history of alcohol or drug addiction.&#xD;
  &#xD;
           11. Subjects who have plans of shaving scalp hair during the study.&#xD;
  &#xD;
           12. Subject has a past or present condition of irritated or visibly inflamed scalp or&#xD;
               severe scalp disease.&#xD;
  &#xD;
           13. Any other condition which could warrant exclusion from the study, as per the&#xD;
               dermatologist's/investigator's discretion.&#xD;
  &#xD;
           14. Pregnant or breastfeeding or planning to become pregnant during the study period.&#xD;
  &#xD;
           15. History of chronic illness which may influence the cutaneous state.&#xD;
  &#xD;
           16. Subjects participating in other similar nutraceuticals, food, supplemental or&#xD;
               therapeutic trials or hair/scalp/skin care products within the last four weeks.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Dr Nayan K Patel</last_name>
      <role>Principal Investigator</role>
      <affiliation>Medical Direcor</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Maheshvari N Patel</last_name>
      <phone>9909013236</phone>
      <email>maheshvari@novobliss.in</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Sheetal J Khandwala</last_name>
      <email>bd@novobliss.in</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>NovoBliss Research Pvt Ltd</name>
        <address>
          <city>Gandhinagar</city>
          <state>Gujarat</state>
          <zip>382421</zip>
          <country>India</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>India</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 7, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>NovoBliss Research Pvt Ltd</investigator_affiliation>
      <investigator_full_name>Dr Nayan Patel</investigator_full_name>
      <investigator_title>Principal Investigator- Medical Director</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Alopecia</mesh_term>
      <mesh_term>Alopecia Areata</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Biotin</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05972512
  org study id: NB230019-OI
  nct id: NCT05972512
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  A randomized, double-blind, three-arm, placebo-controlled, safety, and efficacy study of
        plant-based Biotin and plant-based Biotin with Silica in healthy adult human subjects with
        complaints of hair fall, thin, dry, and brittle hair, and dry skin.
  
        A sufficient number (maximum of 105 (35 subject/test treatment)) of female/male adult
        subjects will be recruited/enrolled to ensure a total of 96 subjects (32 subjects/test
        treatment) complete the study.
  The potential subjects will be screened as per the inclusion & exclusion criteria only after
        obtaining written informed consent from the subjects. Total study visits will be 8 during
        this study.
  
        Visit 01 (Within 30 Days): Screening procedure, Informed consent obtain process, baseline
        evaluations, blood collection, tattoo on scalp, hair growth rate measurement Visit 02 (Day
        01): Enrolments, hair growth rate measurement, other evaluations, product distribution, diary
        distribution, AE reporting (if any.
  
        Visit 03 (Day 27 +2 Days): Treatment period, evaluations, tattoo, hair growth rate
        measurement, diary card review, AE reporting (if any).
  
        Visit 04 (3 Days from Visit 03): Treatment period, evaluations, diary card review, AE
        Reporting (if any).
  
        Visit 05 (Day 57 + 2Days): Treatment period, evaluations, tattoo, hair growth rate
        measurement, diary card review, AE Reporting (if any).
  
        Visit 06 (3 Days from Visit 05): Treatment period, evaluations, diary card review, AE
        Reporting (if any).
  
        Visit 07 (Day 87 +2 Days): Treatment period, evaluations, tattoo, hair growth rate
        measurement, diary card review, AE Reporting (if any).
  
        Visit 08 (3 days from Visit 08): Evaluations, dairy card collection, AE reporting, test
        treatments accountability, End of Study process.
  
        done on Day 04 before Day 01, Day 01 and after test treatment usage will be done on Day 27,
        Day 30, Day 57, Day 60, Day 87, Day 90 as listed-below.
  
          -  60-S Hair Combing Method: Hair Fall.
  
          -  CASALite Nova (Phototrichogram): Hair Density, Thickness, Hair Growth Rate, Scalp
             Condition.
  
          -  PGA Score: Signs of brittle nails, surface roughness, raggedness and peeling.
  
          -  Visioscan®VC 20plus (C+K Instrument): Crow's feet area wrinkles, fine lines, skin
             texture - roughness, dryness, wrinkles, smoothness (Right cheek).
  
          -  MoitureMeterEPiD: Skin hydration (Right cheek).
  
          -  Hair Pull Test: Hair strength.
  
          -  Pluck Test: A:T ratio (Hair Growth Cycle)
  
          -  Cutometer: Skin elasticity (Right cheek).
  
          -  PGA Griffith Scale: Skin dryness, redness, fine wrinkling/lines, coarse wrinkling/lines,
             laxity, roughness and sallowness
  
          -  Tewameter® TM 300: Skin barrier function (Right Cheek)
  
          -  General Appearance of Hair: Hair shininess, hair reflection, hair plasticity, hair
             fizziness, hair volume, hair density Digital photographs: Facial photographs before test
             treatment consumption and after test treatment consumption
  
          -  Blood parameters: CBC, total Serum Cholesterol, Triglyceride, Random Glucose, LDL, HDL
             [Note: blood collection will be performed on Day 01 And Day 90]
  
          -  Blood parameter: HBsAg (Hepatitis B surface antigen) - Screening only
  
          -  Subjective product perception assessment regarding the test treatment's effect on skin
             elasticity, suppleness, skin color, fragrance, taste, skin hydration, skin tone,
             firmness, appearance, hair and nails, strongness and shine.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: A Randomized, Double-Blind, Placebo-Controlled, Safety, and Efficacy Study
  primary purpose: Prevention
  masking: Double (Participant, Investigator)
  masking description: The study is double blind wherein neither the subjects nor the Investigator shall be aware of the test treatment allocation
  measure: Change in hair fall
  time frame: Baseline (Day 01) before dosing to Day 30, Day 60, Day 90 post-dose, between treatments, within treatment and compare with placebo arm
  description: To assess the effectiveness of test treatment in terms of change in hair fall by using 60-s hair comb test
  measure: Change in hair thickness (Unit= µm)
  time frame: From baseline (Day 01) before dosing to Day 30, Day 60 and Day 90 post-dose, between treatments, within treatment and compare with placebo arm
  description: To assess the effectiveness of test treatment in terms of change in hair thickness by CASALite Nova thorough Phototrichogram
  measure: Change in hair growth rate (Unit= µm)
  time frame: From screening (Within 4 Day) to Day 01, Day 27, Day 30, Day 57, Day 60, Day 87 and Day 90 post-dose, between treatment, within treatment, and compare with placebo arm
  description: To assess the effectiveness of test treatment in terms of change in hair growth rate by using CASALite Nova thorough Phototrichogram
  measure: Change in PGA score for sign of brittle nails
  time frame: Baseline (Day 01) before dosing of test treatments to Day 30, Day 60 and Day 90 post-dose, between treatments, within treatment and compare with placebo treated arm
  description: To assess the effectiveness of test treatment in terms of change in PGA score for sign of brittle nails by using 5-point scoring scale Where 0= None and 5= Severe
  measure: Change in Hair Density (Unit= sqcm)
  time frame: rom baseline (Day 01) before dosing to Day 30, Day 60 and Day 90 post-dose, between treatments, within treatment and compare with placebo arm
  description: o assess the effectiveness of test treatment in terms of change in hair density by using CASALite Nova thorough phototrichogram
  measure: Change in PGA score for sign of Nail Surface Roughness
  time frame: From baseline (Day 01) before dosing of test treatments to Day 30, Day 60 and Day 90 post-dose, between treatments, within treatment and compare with placebo treated arm
  description: To assess the effectiveness of test treatment in terms of change in PGA score for sign of nail surface roughness by using 3 point scoring scale Where 0= None, 3= Severe
  measure: Change in PGA score for sign of Surface Raggedness
  time frame: From baseline (Day 01) before dosing of test treatments to Day 30, Day 60 and Day 90 post-dose, between treatments, within treatment and compare with placebo treated arm
  description: To assess the effectiveness of test treatment in terms of change in PGA score for sign of nail surface raggedness by using 3 point scoring scale Where 0= None, 3= Severe
  measure: Change in PGA score for sign of Peeling
  time frame: From baseline (Day 01) before dosing of test treatments to Day 30, Day 60 and Day 90 post-dose, between treatments, within treatment and compare with placebo treated arm
  description: To assess the effectiveness of test treatment in terms of change in PGA score for sign of nail surface peeling by using 4 point scoring scale where 0= none, 3= severe
  measure: Change in facial wrinkle
  time frame: From baseline (Day01) to Day 30, Day 60 and Day 90, between treatments, within treatment and compare with placebo treated arm
  description: To assess the effectiveness of test treatment in terms of change in facial wrinkles by using Visioscan VC 20plus (Instrumental Evaluation)
  measure: Change in fine lines of crow's feet area,
  time frame: from baseline (Day01) to Day 30, Day 60 and Day 90, between treatments, within treatment and compare with placebo treated arm
  description: To assess the effectiveness of test treatment in terms of change in fine lines of crow's feet area by using Visioscan VC 20plus (Instrumental Evaluation)
  measure: Change in skin hydration
  time frame: from baseline (Day01) to Day 30, Day 60 and Day 90, between treatments, within treatment and compare with placebo treated arm
  description: To assess the effectiveness of test treatment in terms of change in skin hydration by using MoistureMeterEpiD (Instrumental Evaluation)
  measure: Change in hair Strength
  time frame: From baseline (Day01) before dosing to Day 30, Day 60 and Day 90 post-dose, between treatments, within treatment and compare with placebo treated arm
  description: To assess the effectiveness of test treatment in terms of change in hair strength by using hair pull test
  measure: Change in skin elasticity
  time frame: From baseline (Day01) before dosing to Day 30, Day 60 and Day 90 post-dose, between treatments, within treatment and compare with placebo treated arm
  description: To assess the effectiveness of test treatment in terms of change in skin elasticity by using Cutometer Dual MPA 580(Instrumental Evaluation)
  measure: Change in PGA Score
  time frame: From baseline (Day01) before dosing to Day 30, Day 60 and Day 90 post-dose, between treatments, within treatment and compare with placebo treated arm
  description: To assess the effectiveness of test treatment in terms of change in PGA scores i.e. dryness, redness, fine lines, coarse wrinkle, laxity, roughness, and sallowness by using Griffith scale Where 0= No appearance and 9= Severe
  measure: Change in barrier function of skin
  time frame: From baseline (Day01) before dosing to Day 30, Day 60 and Day 90 post-dose, between treatments, within treatment and compare with placebo treated arm
  description: To assess the effectiveness of test treatment in terms of change in barrier function of skin by using Tewameter TM Hex(Instrumental Evaluation)
  measure: Change in general appearance of hair
  time frame: From baseline (Day01) before dosing to Day 30, Day 60 and Day 90 post-dose, between treatments, within treatment and compare with placebo treated arm
  description: To assess the effectiveness of test treatment in terms of change in general appearance of hair such as hair shininess, hair reflection, hair volume, hair density, hair plasticity, hair frizziness by dermatologist trained evaluator
  measure: Change in Anagen: Telogen ratio
  time frame: From baseline (Day01) to Day 90 (+2Days), between treatments, within treatment and compare with placebo treated arm
  description: To assess the effectiveness of test treatment in terms of change in Anagen: Telogen ratio of hair by using hair pluck test
  measure: Change in facial photographs(Left/Center/Right)
  time frame: From baseline before usage of test treatments on Day 01, and after usage of test treatments on Day 30, Day 60, Day 90
  description: Change in facial photographs (Left/Center/Right) of the subject by using Nikol Digital Camera D3300
  measure: Treatment perception questionnaire
  time frame: From before dosing of test treatments to after usage of test treatments on Day 30, Day 60, Day 90
  description: To assess the effectiveness of test treatment in terms of treatment perception by using 9 point hedonic scale
  measure: Change in Complete Blood Count
  time frame: From Day 01 and Day 90
  description: Safety of test treatment will be assessed in terms of difference in Complete Blood Count
  measure: Change in silicon deposits on hair cuticle
  time frame: From baseline (Day01) before dosing to Day 90 post-dose, between treatments, within treatment and compare with placebo treated arm
  description: To assess the effect of test treatments in terms of change silicon deposits on hair cuticle by using Scanning Electrone Microscope (8 subject/ test treatment)
  measure: Change in Skin Texture
  time frame: From baseline (Day01) to Day 30, Day 60 and Day 90, between treatments, within treatment and compare with placebo treated arm
  description: To assess the effectiveness of test treatment in terms of change in Skin texture by using Visioscan VC 20plus
  measure: Change in Total Serum Cholesterol
  time frame: From Day 01 and Day 90
  description: Safety of test treatment will be assessed in terms of difference in Total Serum Cholesterol level
  measure: Change in Triglycerides
  time frame: From Day 01 and Day 90
  description: Safety of test treatment will be assessed in terms of difference in Triglycerides level
  measure: Change in LDL level
  time frame: From Day 01 and Day 90
  description: Safety of test treatment will be assessed in terms of difference in LDL level
  measure: Change in HDL level
  time frame: From Day 01 and Day 90
  description: Safety of test treatment will be assessed in terms of difference in HDL level
  measure: Change in Random Glucose Level
  time frame: From Day 01 and Day 90
  description: Safety of test treatment will be assessed in terms of difference in Random Glucose Level
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: The test treatment will be taken two times a day.
  arm group label: Botanical Extract of standardised for biotin (1250 mcg)
  arm group type: Experimental
  description: The standardised botanical extract of biotin is specially formulated for healthier hair and skin. Biotin promotes the hair growth.
  arm group label: Botanical Extract of standardised for biotin (1250mcg) + 10 mg Silica
  arm group type: Experimental
  description: The standardised botanical extract of biotin and silica is specially formulated for healthier hair. The combination of biotin and silica will helpful in hair growth, reduces shedding, and improves the health of hair.
  intervention type: Other
  intervention name: Placebo
  description: Mode of usage: Two times a day Route of administration: Oral
  arm group label: Placebo
  intervention type: Dietary Supplement
  intervention name: Botanical extract of standardized biotin
  description: Mode of usage: Two times a day Route of administration: Oral
  arm group label: Botanical Extract of standardised for biotin (1250 mcg)
  intervention type: Dietary Supplement
  intervention name: Botanical extract of standardised biotin with silica
  description: Mode of usage: Two times a day Route of administration: Oral
  arm group label: Botanical Extract of standardised for biotin (1250mcg) + 10 mg Silica
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 60 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Dr Nayan K Patel
  role: Principal Investigator
  affiliation: Medical Direcor
  last name: Maheshvari N Patel
  phone: 9909013236
  email: maheshvari@novobliss.in
  last name: Sheetal J Khandwala
  email: bd@novobliss.in
  facility: 
  country: India
  responsible party type: Principal Investigator
  investigator affiliation: NovoBliss Research Pvt Ltd
  investigator full name: Dr Nayan Patel
  investigator title: Principal Investigator- Medical Director
  mesh term: Alopecia
  mesh term: Alopecia Areata
  mesh term: Biotin
  sharing ipd: No