Evaluation of Safety and Efficacy of Keratin Hair Therapy

NCT04489576 | Unknown DMC

• 1 other identifier: Sohagu310
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Hair Damage

Keywords

Hair keratin; Hair straightening

Outcome Measures

Primary Outcomes (4)

• Change of hair shedding using the Visual analogue scale (VAS)

  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

  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

  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

  to detect any side effects that will be reported either by the patient or by the physician.

  at 6 months

Secondary Outcomes (1)

• Change of patient satisfaction questionnaire about keratin treatment

  Baseline, 2 months, 4 months, 6 months

Study Arms (3)

Group (1): Treatment with keratin cure hair

ACTIVE COMPARATOR

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 ®)

Group (2): Treatment with Qod max keratin hair

ACTIVE COMPARATOR

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 ®)

Group (3): Treatment without keratin hair treatment

PLACEBO COMPARATOR

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 ®)

Interventions

Keratin hair treatment (Keratin Cure ®) versus (QOD Max ®) PROCEDURE

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.

Also known as: Hair straightening treatment

Group (1): Treatment with keratin cure hair; Group (2): Treatment with Qod max keratin hair; Group (3): Treatment without keratin hair treatment

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: Female participants will be included as females are more interested in keratin hair straightening.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University

Sohag, 82524, Egypt

RECRUITING

Study Officials

• Amr Abdelhamed, MD

  Faculty of Medicine, Sohag University, Egypt

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amr Abdelhamed, MD

CONTACT

+201005825574; dramr80@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The participants, investigator and the outcome assessor will be blinded as regards the outcome measures evaluation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, Department of Dermatology

Model Details: Keratin hair application

Study Record Dates

• First Submitted: July 22, 2020
• First Posted: July 28, 2020
• Study Start: November 15, 2020
• Primary Completion: April 1, 2021
• Study Completion: June 1, 2021
• Last Updated: January 11, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data will be available within 6 months after finishing the study.

Locations

EG (1)