Evaluation of Safety and Efficacy of Keratin Hair Therapy

January 7, 2021 updated by: Amr Abdelhamed, Sohag University

Efficacy and Safety of Keratin Hair Therapy on the Health of Hair and Scalp

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Sohag, Egypt, 82524
        • Recruiting
        • Sohag University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • Hair straightening treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 2 months, 4 months, 6 months
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.
Baseline, 2 months, 4 months, 6 months
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
Baseline, 2 months, 4 months, 6 months
Safety evaluation
Time Frame: at 6 months
to detect any side effects that will be reported either by the patient or by the physician.
at 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 2 months, 4 months, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2020

Primary Completion (Anticipated)

April 1, 2021

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

July 22, 2020

First Submitted That Met QC Criteria

July 27, 2020

First Posted (Actual)

July 28, 2020

Study Record Updates

Last Update Posted (Actual)

January 11, 2021

Last Update Submitted That Met QC Criteria

January 7, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Sohagu310

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Individual participant data sharing plan will include the study protocol, statistical analysis plan, and the clinical study report.

IPD Sharing Time Frame

Data will be available within 6 months after finishing the study.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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