Evaluation of Safety and Efficacy of Keratin Hair Therapy

• ClinicalTrials.gov Identifier: NCT04489576
• Recruitment Status: Unknown
• First Posted: July 28, 2020
• Last Update Posted: January 11, 2021
• Sponsor: Sohag University
• Information provided by (Responsible Party): Amr Abdelhamed, Sohag University

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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.

Contacts and Locations

Contacts

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

Locations

Egypt

Sohag University; Recruiting

Sohag, Egypt, 82524

Contact: Amr Abdelhamed, MD 01005825574 dramr80@yahoo.com

Sponsors and Collaborators

Sohag University

Investigators

• Principal Investigator: Amr Abdelhamed, MD; Faculty of Medicine, Sohag University, Egypt

More Information

• 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
• 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.

• 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