<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/NCT03272750</url>
  </required_header>
  <id_info>
    <org_study_id>E1416</org_study_id>
    <nct_id>NCT03272750</nct_id>
  </id_info>
  <brief_title>Evaluation of Tolerance and Trichological Efficacy of a Food Supplement</brief_title>
  <official_title>Controlled, Randomized, Double Blind Study, for the Evaluation of Tolerance and Trichological Efficacy of a Food Supplement: Bioscalin® New Formulation Versus Reference Formulation Currently on the Market and Placebo</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Derming SRL</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Derming SRL</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Controlled, randomized, double blind study, for the evaluation of tolerance and trichological&#xD;
      efficacy of a food supplement: Bioscalin® new formulation versus reference formulation&#xD;
      currently on the market and placebo&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aim of the study was to evaluate clinically and by non-invasive instrumental measurements the&#xD;
      trichological activity of a food supplement taken for 3 months by subjects of both sexes,&#xD;
      aged between 18-60 years, affected by telogen effluvium, with a percentage of hair in anagen&#xD;
      phase &lt; 75%.&#xD;
&#xD;
      In particular the study foresaw the evaluation of the trichological activity of the&#xD;
      Bioscalin® new formulation with Galeopsis Segetum in comparison to a reference product&#xD;
      currently on the market and to placebo.&#xD;
&#xD;
      It was also aim of this study to evaluate treatment tolerance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 4, 2016</start_date>
  <completion_date type="Actual">March 31, 2017</completion_date>
  <primary_completion_date type="Actual">March 31, 2017</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline of the percentage of hair in anagen phase</measure>
    <time_frame>Basal visit (T0),1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4).</time_frame>
    <description>Percentage of hair in anagen phase (anagen hair grow &gt; 0,3 mm/die ) was calculate by TrichoScan software on the microscopic images (with 20X magnification) captured with FotoFinderDermoscope.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline of the hair density</measure>
    <time_frame>Basal visit (T0),1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4).</time_frame>
    <description>Hair density (hair number/cm2) was calculate by TrichoScan software on the microscopic images (with 20X magnification) captured with FotoFinderDermoscope.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline of the percentage of vellus hair</measure>
    <time_frame>Basal visit (T0),1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4).</time_frame>
    <description>Percentage of vellus hair (vellus hair has a diameter &lt;0.04 mm)was calculate by TrichoScan software on the microscopic images (with 20X magnification) captured with FotoFinderDermoscope.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hair parting test</measure>
    <time_frame>Basal visit (T0), after 1 (T1), 2 (T2) and 3 (T3) month-treatment and a follow-up visit 1 month after the last food supplement assumption (T4 months).</time_frame>
    <description>Evaluation of hair thickening</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Videodermatoscopy</measure>
    <time_frame>Basal visit (T0), after 1 (T1), 2 (T2) and 3 (T3) month-treatment and a follow-up visit 1 month after the last food supplement assumption (T4 months).</time_frame>
    <description>Evaluation to visualize any morphological alteration/variation of the hair often imperceptible to the naked eye</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pull test</measure>
    <time_frame>Basal visit (T0), after 1 (T1), 2 (T2) and 3 (T3) month-treatment and a follow-up visit 1 month after the last food supplement assumption (T4 months).</time_frame>
    <description>Evaluation of tensile strength of the hair</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sebometry</measure>
    <time_frame>Basal visit (T0), after 1 (T1), 2 (T2) and 3 (T3) month-treatment and a follow-up visit 1 month after the last food supplement assumption (T4 months).</time_frame>
    <description>Measurement of surface lipid level</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">51</enrollment>
  <condition>Telogen Effluvium</condition>
  <arm_group>
    <arm_group_label>Bioscalin® new formulation with Galeopsis Segetum</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2 placebo capsules + 1 Bioscalin with Galeopsis Segetum table</description>
  </arm_group>
  <arm_group>
    <arm_group_label>REFERENCE PRODUCT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>2 reference product capsules + 1 placebo tablet</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PLACEBO</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>2 placebo capsules + 1 placebo tablet</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Bioscalin® new formulation with Galeopsis Segetum</intervention_name>
    <description>Total duration of the study was 4 months; each subject, took by mouth two capsules/die of placebo at breakfast and one tablet/die of study product at lunch for the first 3 months of the trial.</description>
    <arm_group_label>Bioscalin® new formulation with Galeopsis Segetum</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Reference product</intervention_name>
    <description>Total duration of the study was 4 months; each subject, took by mouth two capsules/die of reference product at breakfast and one tablet/die of placebo at lunch for the first 3 months of the trial.</description>
    <arm_group_label>REFERENCE PRODUCT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Total duration of the study was 4 months; each subject, took by mouth two capsules/die of placebo at breakfast and one tablet/die of placebo at lunch for the first 3 months of the trial.</description>
    <arm_group_label>PLACEBO</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  both sexes;&#xD;
&#xD;
          -  age range 18-60 years old;&#xD;
&#xD;
          -  with telogen effluvium and a percentage of anagen ratio at inclusion &lt; 75%;&#xD;
&#xD;
          -  no-smokers;&#xD;
&#xD;
          -  accepting to follow the instruction received by the investigator;&#xD;
&#xD;
          -  disposable and able to return to the study centre at the established times;&#xD;
&#xD;
          -  accepting to not change their habits regarding food, physical activity, hair and scalp&#xD;
             cleansing;&#xD;
&#xD;
          -  accepting to not receive any drugs/cosmetics treatment able to interfere with the&#xD;
             study results;&#xD;
&#xD;
          -  no participation in a similar study actually or during the previous 6 months;&#xD;
&#xD;
          -  accepting to sign the Informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy (for female subjects);&#xD;
&#xD;
          -  lactation (for female subjects);&#xD;
&#xD;
          -  subjects not in menopause who does not use adequate contraceptive precautions in order&#xD;
             to avoid pregnancies during the study;&#xD;
&#xD;
          -  subjects not in menopause who do not accept to perform the pregnancy test during the&#xD;
             basal visit, after 2 (T2) and 3 (T3) month-treatment;&#xD;
&#xD;
          -  change in the normal habits regarding food, physical activity, physical activity, hair&#xD;
             and scalp cleansing during the month preceding the test;&#xD;
&#xD;
          -  sensitivity to the test product or its ingredients (to be assessed by the investigator&#xD;
             during the baseline visit). The product contains gluten (aroma of grain), then all&#xD;
             subjects with celiac disease or gluten intolerance should be excluded.&#xD;
&#xD;
          -  subjects whose insufficient adhesion to the study protocol is foreseeable;&#xD;
&#xD;
          -  participation in a similar study actually or during the previous 6 months.&#xD;
&#xD;
          -  presence of cutaneous disease on the tested area, as lesions, scars, malformations;&#xD;
&#xD;
          -  clinical and significant skin condition on the test area (e.g. active eczema,&#xD;
             dermatitis, psoriasis etc.).&#xD;
&#xD;
          -  Diabetes&#xD;
&#xD;
          -  endocrine disease&#xD;
&#xD;
          -  hepatic disorder&#xD;
&#xD;
          -  renal disorder&#xD;
&#xD;
          -  cardiac disorder&#xD;
&#xD;
          -  pulmonary disease&#xD;
&#xD;
          -  cancer&#xD;
&#xD;
          -  neurological or psychological disease&#xD;
&#xD;
          -  inflammatory/immunosuppressive disease&#xD;
&#xD;
          -  drug allergy&#xD;
&#xD;
          -  anti-inflammatory drugs, anti-histaminic, topic and systemic corticosteroids,&#xD;
             narcotic, antidepressant, immunosuppressive drugs (with the except of contraceptive or&#xD;
             hormonal treatment starting more than 1 year ago);&#xD;
&#xD;
          -  assumption of drugs able to influence the test results in the investigator opinion.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 1, 2017</study_first_submitted>
  <study_first_submitted_qc>September 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>September 1, 2017</last_update_submitted>
  <last_update_submitted_qc>September 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Derming SRL</investigator_affiliation>
    <investigator_full_name>Adele Sparavigna</investigator_full_name>
    <investigator_title>Dermatologist, Principal Investigator</investigator_title>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03272750
org study id: E1416
nct id: NCT03272750
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Controlled, randomized, double blind study, for the evaluation of tolerance and trichological
      efficacy of a food supplement: Bioscalin® new formulation versus reference formulation
      currently on the market and placebo
Aim of the study was to evaluate clinically and by non-invasive instrumental measurements the
      trichological activity of a food supplement taken for 3 months by subjects of both sexes,
      aged between 18-60 years, affected by telogen effluvium, with a percentage of hair in anagen
      phase < 75%.

      In particular the study foresaw the evaluation of the trichological activity of the
      Bioscalin® new formulation with Galeopsis Segetum in comparison to a reference product
      currently on the market and to placebo.

      It was also aim of this study to evaluate treatment tolerance.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change from baseline of the percentage of hair in anagen phase
time frame: Basal visit (T0),1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4).
description: Percentage of hair in anagen phase (anagen hair grow > 0,3 mm/die ) was calculate by TrichoScan software on the microscopic images (with 20X magnification) captured with FotoFinderDermoscope.
measure: Change from baseline of the hair density
time frame: Basal visit (T0),1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4).
description: Hair density (hair number/cm2) was calculate by TrichoScan software on the microscopic images (with 20X magnification) captured with FotoFinderDermoscope.
measure: Change from baseline of the percentage of vellus hair
time frame: Basal visit (T0),1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4).
description: Percentage of vellus hair (vellus hair has a diameter <0.04 mm)was calculate by TrichoScan software on the microscopic images (with 20X magnification) captured with FotoFinderDermoscope.
measure: Hair parting test
time frame: Basal visit (T0), after 1 (T1), 2 (T2) and 3 (T3) month-treatment and a follow-up visit 1 month after the last food supplement assumption (T4 months).
description: Evaluation of hair thickening
measure: Videodermatoscopy
time frame: Basal visit (T0), after 1 (T1), 2 (T2) and 3 (T3) month-treatment and a follow-up visit 1 month after the last food supplement assumption (T4 months).
description: Evaluation to visualize any morphological alteration/variation of the hair often imperceptible to the naked eye
measure: Pull test
time frame: Basal visit (T0), after 1 (T1), 2 (T2) and 3 (T3) month-treatment and a follow-up visit 1 month after the last food supplement assumption (T4 months).
description: Evaluation of tensile strength of the hair
measure: Sebometry
time frame: Basal visit (T0), after 1 (T1), 2 (T2) and 3 (T3) month-treatment and a follow-up visit 1 month after the last food supplement assumption (T4 months).
description: Measurement of surface lipid level
arm group label: Bioscalin® new formulation with Galeopsis Segetum
arm group type: Experimental
description: 2 placebo capsules + 1 Bioscalin with Galeopsis Segetum table
arm group label: REFERENCE PRODUCT
arm group type: Active Comparator
description: 2 reference product capsules + 1 placebo tablet
arm group label: PLACEBO
arm group type: Placebo Comparator
description: 2 placebo capsules + 1 placebo tablet
intervention type: Dietary Supplement
intervention name: Bioscalin® new formulation with Galeopsis Segetum
description: Total duration of the study was 4 months; each subject, took by mouth two capsules/die of placebo at breakfast and one tablet/die of study product at lunch for the first 3 months of the trial.
arm group label: Bioscalin® new formulation with Galeopsis Segetum
intervention type: Dietary Supplement
intervention name: Reference product
description: Total duration of the study was 4 months; each subject, took by mouth two capsules/die of reference product at breakfast and one tablet/die of placebo at lunch for the first 3 months of the trial.
arm group label: REFERENCE PRODUCT
intervention type: Dietary Supplement
intervention name: Placebo
description: Total duration of the study was 4 months; each subject, took by mouth two capsules/die of placebo at breakfast and one tablet/die of placebo at lunch for the first 3 months of the trial.
arm group label: PLACEBO
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Derming SRL
investigator full name: Adele Sparavigna
investigator title: Dermatologist, Principal Investigator