Evaluation of Safety and Efficacy of Keratin Hair Therapy

Sohag University

Status: Unknown

Conditions: Hair Damage

Treatments: Procedure: Keratin hair treatment (Keratin Cure ®) versus (QOD Max ®)

Study type: Interventional

Funder types: Other

Identifiers

NCT04489576

Sohagu310

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 3 patient groups, including a placebo group

Group (1): Treatment with keratin cure hair

Active Comparator group

Description:

Group (1): Patients will be treated with Keratin cure ® hair treatment. It will be applied once with use of a flat iron.

Treatment:

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

Group (2): Treatment with Qod max keratin hair

Active Comparator group

Description:

Group (2): Patients will be treated with QOD Max ® keratin hair treatment. It will be applied once with use of a flat iron.

Treatment:

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

Group (3): Treatment without keratin hair treatment

Placebo Comparator group

Description:

Group (3): Patients will be treated without keratin hair treatment, but the same steps of keratin application will be followed.

Treatment:

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