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Evaluation of Safety and Efficacy of Keratin Hair Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04489576
Recruitment Status : Unknown
Verified January 2021 by Amr Abdelhamed, Sohag University.
Recruitment status was:  Recruiting
First Posted : July 28, 2020
Last Update Posted : January 11, 2021
Sponsor:
Information provided by (Responsible Party):
Amr Abdelhamed, Sohag University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hair Damage Procedure: Keratin hair treatment (Keratin Cure ®) versus (QOD Max ®) Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Keratin hair application
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: The participants, investigator and the outcome assessor will be blinded as regards the outcome measures evaluation
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Keratin Hair Therapy on the Health of Hair and Scalp
Actual Study Start Date : November 15, 2020
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : June 2021

Arm Intervention/treatment
Active Comparator: Group (1): Treatment with keratin cure hair
Group (1): Patients will be treated with Keratin cure ® hair treatment. It will be applied once with use of a flat iron.
Procedure: Keratin hair treatment (Keratin Cure ®) versus (QOD Max ®)
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.
Other Name: Hair straightening treatment

Active Comparator: Group (2): Treatment with Qod max keratin hair
Group (2): Patients will be treated with QOD Max ® keratin hair treatment. It will be applied once with use of a flat iron.
Procedure: Keratin hair treatment (Keratin Cure ®) versus (QOD Max ®)
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.
Other Name: Hair straightening treatment

Placebo Comparator: Group (3): Treatment without keratin hair treatment
Group (3): Patients will be treated without keratin hair treatment, but the same steps of keratin application will be followed.
Procedure: Keratin hair treatment (Keratin Cure ®) versus (QOD Max ®)
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.
Other Name: Hair straightening treatment




Primary Outcome Measures :
  1. Change of hair shedding using the Visual analogue scale (VAS) [ Time Frame: Baseline, 2 months, 4 months, 6 months ]
    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.

  2. Change of hair morphology using trichoscope [ Time Frame: Baseline, 2 months, 4 months, 6 months ]
    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.

  3. Change of hair morphology using Transmission Electron Microscopic examination [ Time Frame: Baseline, 2 months, 4 months, 6 months ]
    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

  4. Safety evaluation [ Time Frame: at 6 months ]
    to detect any side effects that will be reported either by the patient or by the physician.


Secondary Outcome Measures :
  1. Change of patient satisfaction questionnaire about keratin treatment [ Time Frame: Baseline, 2 months, 4 months, 6 months ]
    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.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female participants will be included as females are more interested in keratin hair straightening.
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • The study will include female patients aged between 18 and 55 years, with hair curl types from III to V according to L'Oréal Curl Classification. The Patients will be randomized by simple randomization into 3 groups, 10 patients for each.

Exclusion Criteria:

  • Pregnant and lactating women.
  • Patients having hair loss or under treatment of hair loss in last 3 months.
  • Patients with previous history of keratin treatment.
  • Patients with scalp affection including infection, injury or surgery
  • Patients with chronic medical diseases.
  • Patients with anemia (hemoglobin level <10mg/dl) or under its treatment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04489576


Contacts
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Contact: Amr Abdelhamed, MD +201005825574 ext 0020 dramr80@yahoo.com

Locations
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Egypt
Sohag University Recruiting
Sohag, Egypt, 82524
Contact: Amr Abdelhamed, MD    01005825574    dramr80@yahoo.com   
Sponsors and Collaborators
Sohag University
Investigators
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Principal Investigator: Amr Abdelhamed, MD Faculty of Medicine, Sohag University, Egypt
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Responsible Party: Amr Abdelhamed, Associate professor, Department of Dermatology, Sohag University
ClinicalTrials.gov Identifier: NCT04489576    
Other Study ID Numbers: Sohagu310
First Posted: July 28, 2020    Key Record Dates
Last Update Posted: January 11, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data sharing plan will include the study protocol, statistical analysis plan, and the clinical study report.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data will be available within 6 months after finishing the study.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amr Abdelhamed, Sohag University:
Hair keratin
Hair straightening