<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/NCT04489576</url>
  </required_header>
  <id_info>
    <org_study_id>Sohagu310</org_study_id>
    <nct_id>NCT04489576</nct_id>
  </id_info>
  <brief_title>Evaluation of Safety and Efficacy of Keratin Hair Therapy</brief_title>
  <official_title>Efficacy and Safety of Keratin Hair Therapy on the Health of Hair and Scalp</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sohag University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sohag University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Hair appearance is an important issue for females. Treatment of hair with keratin has been&#xD;
      popular among females nowadays. Although chemical hair straightening application has a&#xD;
      beneficial effect on hair shafts with the repair of the broken cuticle, some side effects may&#xD;
      occur. Therefore, this study aims to study the efficacy and safety of such new&#xD;
      non-formaldehyde widely used keratin treatments on hair by assessment of changes of the&#xD;
      scalp, hair density, and the morphology, color, and ultrastructure of hair shaft after&#xD;
      application.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hair is an important feature for most women that contribute to one's individual identity. The&#xD;
      appearance and morphology of the hair is one of the divergent traits in humans. Keratin in&#xD;
      hair care products has two effects; it can penetrate the cortex of the hair fiber improving&#xD;
      the mechanical properties of damaged fibers and promotes a surface coating that prevents or&#xD;
      decreases water diffusion through the hair fibers.These properties have beneficial effects on&#xD;
      the hair structure replacing lost keratin.However, the side effects and safety of this&#xD;
      treatment have not yet been completely evaluated.There are many different brands of the&#xD;
      keratin hair treatment, all with nearly the same basic chemical composition. Non-formaldehyde&#xD;
      containing keratin straightening products, also known as safe keratin treatments (SKT) have&#xD;
      recently been introduced to the market.Therefore, this study aims to study the efficacy and&#xD;
      safety of such new non formaldehyde widely used keratin treatments on hair.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 15, 2020</start_date>
  <completion_date type="Anticipated">June 2021</completion_date>
  <primary_completion_date type="Anticipated">April 2021</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>Keratin hair application</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>The participants, investigator and the outcome assessor will be blinded as regards the outcome measures evaluation</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change of hair shedding using the Visual analogue scale (VAS)</measure>
    <time_frame>Baseline, 2 months, 4 months, 6 months</time_frame>
    <description>It will be used to evaluate hair shedding. Hair shedding is scored on a scale of 1-6. Women are asked to look at the scale and point to the photograph that best correlates with the amount of hair shed on an average day. Grades 1-3 are considered normal. Grade 4 is borderline, while Grades 5 and 6 indicate excessive shedding.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of hair morphology using trichoscope</measure>
    <time_frame>Baseline, 2 months, 4 months, 6 months</time_frame>
    <description>It will be used to evaluate hair structure and scalp. Hair density/cm 2 and thickness (mm) will be measured in the frontal, temporal and vertex areas in all participants.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of hair morphology using Transmission Electron Microscopic examination</measure>
    <time_frame>Baseline, 2 months, 4 months, 6 months</time_frame>
    <description>Randomly selected samples of each group will be fixed in 3% glutaraldehyde for over a period of 4 hours at 4°C and processed to be examined by transmission electron microscope</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety evaluation</measure>
    <time_frame>at 6 months</time_frame>
    <description>to detect any side effects that will be reported either by the patient or by the physician.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of patient satisfaction questionnaire about keratin treatment</measure>
    <time_frame>Baseline, 2 months, 4 months, 6 months</time_frame>
    <description>A 5 items Questionnaire will be completed by the patients to evaluate their satisfaction about the treatment. The questionnaire consists of Q1 (1-5), Q2,3 (1-7), Q4 (1-4) and Q5 has 3 sub-items Q5a, Q5b, Q5c (1-5 for each). Total score ranges from 7-38. Higher scores are associated with higher dissatisfaction.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Hair Damage</condition>
  <arm_group>
    <arm_group_label>Group (1): Treatment with keratin cure hair</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group (1): Patients will be treated with Keratin cure ® hair treatment. It will be applied once with use of a flat iron.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group (2): Treatment with Qod max keratin hair</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group (2): Patients will be treated with QOD Max ® keratin hair treatment. It will be applied once with use of a flat iron.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group (3): Treatment without keratin hair treatment</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Group (3): Patients will be treated without keratin hair treatment, but the same steps of keratin application will be followed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Keratin hair treatment (Keratin Cure ®) versus (QOD Max ®)</intervention_name>
    <description>Hair will be treated with 2 different types of keratin in groups 1 &amp; 2. All steps of keratin application will be done in group 3 without keratin application as a control group.</description>
    <arm_group_label>Group (1): Treatment with keratin cure hair</arm_group_label>
    <arm_group_label>Group (2): Treatment with Qod max keratin hair</arm_group_label>
    <arm_group_label>Group (3): Treatment without keratin hair treatment</arm_group_label>
    <other_name>Hair straightening treatment</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The study will include female patients aged between 18 and 55 years, with hair curl&#xD;
             types from III to V according to L'Oréal Curl Classification. The Patients will be&#xD;
             randomized by simple randomization into 3 groups, 10 patients for each.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant and lactating women.&#xD;
&#xD;
          -  Patients having hair loss or under treatment of hair loss in last 3 months.&#xD;
&#xD;
          -  Patients with previous history of keratin treatment.&#xD;
&#xD;
          -  Patients with scalp affection including infection, injury or surgery&#xD;
&#xD;
          -  Patients with chronic medical diseases.&#xD;
&#xD;
          -  Patients with anemia (hemoglobin level &lt;10mg/dl) or under its treatment.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Female participants will be included as females are more interested in keratin hair straightening.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amr Abdelhamed, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Faculty of Medicine, Sohag University, Egypt</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Amr Abdelhamed, MD</last_name>
    <phone>+201005825574</phone>
    <phone_ext>0020</phone_ext>
    <email>dramr80@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Sohag University</name>
      <address>
        <city>Sohag</city>
        <zip>82524</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amr Abdelhamed, MD</last_name>
      <phone>01005825574</phone>
      <email>dramr80@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>January 7, 2021</last_update_submitted>
  <last_update_submitted_qc>January 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sohag University</investigator_affiliation>
    <investigator_full_name>Amr Abdelhamed</investigator_full_name>
    <investigator_title>Associate professor, Department of Dermatology</investigator_title>
  </responsible_party>
  <keyword>Hair keratin</keyword>
  <keyword>Hair straightening</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Individual participant data sharing plan will include the study protocol, statistical analysis plan, and the clinical study report.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Data will be available within 6 months after finishing the study.</ipd_time_frame>
  </patient_data>
  <!-- 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/NCT04489576
org study id: Sohagu310
nct id: NCT04489576
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Hair appearance is an important issue for females. Treatment of hair with keratin has been
      popular among females nowadays. Although chemical hair straightening application has a
      beneficial effect on hair shafts with the repair of the broken cuticle, some side effects may
      occur. Therefore, this study aims to study the efficacy and safety of such new
      non-formaldehyde widely used keratin treatments on hair by assessment of changes of the
      scalp, hair density, and the morphology, color, and ultrastructure of hair shaft after
      application.
Hair is an important feature for most women that contribute to one's individual identity. The
      appearance and morphology of the hair is one of the divergent traits in humans. Keratin in
      hair care products has two effects; it can penetrate the cortex of the hair fiber improving
      the mechanical properties of damaged fibers and promotes a surface coating that prevents or
      decreases water diffusion through the hair fibers.These properties have beneficial effects on
      the hair structure replacing lost keratin.However, the side effects and safety of this
      treatment have not yet been completely evaluated.There are many different brands of the
      keratin hair treatment, all with nearly the same basic chemical composition. Non-formaldehyde
      containing keratin straightening products, also known as safe keratin treatments (SKT) have
      recently been introduced to the market.Therefore, this study aims to study the efficacy and
      safety of such new non formaldehyde widely used keratin treatments on hair.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Keratin hair application
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: The participants, investigator and the outcome assessor will be blinded as regards the outcome measures evaluation
measure: Change of hair shedding using the Visual analogue scale (VAS)
time frame: Baseline, 2 months, 4 months, 6 months
description: It will be used to evaluate hair shedding. Hair shedding is scored on a scale of 1-6. Women are asked to look at the scale and point to the photograph that best correlates with the amount of hair shed on an average day. Grades 1-3 are considered normal. Grade 4 is borderline, while Grades 5 and 6 indicate excessive shedding.
measure: Change of hair morphology using trichoscope
time frame: Baseline, 2 months, 4 months, 6 months
description: It will be used to evaluate hair structure and scalp. Hair density/cm 2 and thickness (mm) will be measured in the frontal, temporal and vertex areas in all participants.
measure: Change of hair morphology using Transmission Electron Microscopic examination
time frame: Baseline, 2 months, 4 months, 6 months
description: Randomly selected samples of each group will be fixed in 3% glutaraldehyde for over a period of 4 hours at 4°C and processed to be examined by transmission electron microscope
measure: Safety evaluation
time frame: at 6 months
description: to detect any side effects that will be reported either by the patient or by the physician.
measure: Change of patient satisfaction questionnaire about keratin treatment
time frame: Baseline, 2 months, 4 months, 6 months
description: A 5 items Questionnaire will be completed by the patients to evaluate their satisfaction about the treatment. The questionnaire consists of Q1 (1-5), Q2,3 (1-7), Q4 (1-4) and Q5 has 3 sub-items Q5a, Q5b, Q5c (1-5 for each). Total score ranges from 7-38. Higher scores are associated with higher dissatisfaction.
arm group label: Group (1): Treatment with keratin cure hair
arm group type: Active Comparator
description: Group (1): Patients will be treated with Keratin cure ® hair treatment. It will be applied once with use of a flat iron.
arm group label: Group (2): Treatment with Qod max keratin hair
arm group type: Active Comparator
description: Group (2): Patients will be treated with QOD Max ® keratin hair treatment. It will be applied once with use of a flat iron.
arm group label: Group (3): Treatment without keratin hair treatment
arm group type: Placebo Comparator
description: Group (3): Patients will be treated without keratin hair treatment, but the same steps of keratin application will be followed.
intervention type: Procedure
intervention name: Keratin hair treatment (Keratin Cure ®) versus (QOD Max ®)
description: Hair will be treated with 2 different types of keratin in groups 1 & 2. All steps of keratin application will be done in group 3 without keratin application as a control group.
arm group label: Group (1): Treatment with keratin cure hair
arm group label: Group (2): Treatment with Qod max keratin hair
arm group label: Group (3): Treatment without keratin hair treatment
other name: Hair straightening treatment
criteria: 
gender: Female
gender based: Yes
gender description: Female participants will be included as females are more interested in keratin hair straightening.
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Amr Abdelhamed, MD
role: Principal Investigator
affiliation: Faculty of Medicine, Sohag University, Egypt
last name: Amr Abdelhamed, MD
phone: +201005825574
phone ext: 0020
email: dramr80@yahoo.com
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Sohag University
investigator full name: Amr Abdelhamed
investigator title: Associate professor, Department of Dermatology
sharing ipd: Yes
ipd description: Individual participant data sharing plan will include the study protocol, statistical analysis plan, and the clinical study report.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Data will be available within 6 months after finishing the study.