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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change of patient satisfaction questionnaire about keratin treatment | 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 |
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Inclusion Criteria:
Exclusion Criteria:
Female participants will be included as females are more interested in keratin hair straightening.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amr Abdelhamed, MD | Contact | +201005825574 | 0020 | dramr80@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Amr Abdelhamed, MD | Faculty of Medicine, Sohag University, Egypt | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sohag University | Recruiting | Sohag | 82524 | Egypt |
Individual participant data sharing plan will include the study protocol, statistical analysis plan, and the clinical study report.
Data will be available within 6 months after finishing the study.
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Keratin hair application
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The participants, investigator and the outcome assessor will be blinded as regards the outcome measures evaluation
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