Evaluation of Safety and Efficacy of Keratin Hair Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-15

Study Completion Date

2021-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hair Damage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Keratin hair application

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

The participants, investigator and the outcome assessor will be blinded as regards the outcome measures evaluation

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type 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.

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.

Group Type PLACEBO_COMPARATOR

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

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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Hair straightening treatment

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes