Clinical trial NCT04489576: Evaluation of Safety and Efficacy of Keratin Hair Therapy
Official title: Efficacy and Safety of Keratin Hair Therapy on the Health of Hair and Scalp
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hair Damage
Keywords: Hair keratin
Hair straightening
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2020-07-28
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Keratin hair application
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change of hair shedding using the Visual analogue scale (VAS)
timeFrame: Baseline, 2 months, 4 months, 6 months
measure: Change of hair morphology using trichoscope
timeFrame: Baseline, 2 months, 4 months, 6 months
measure: Change of hair morphology using Transmission Electron Microscopic examination
timeFrame: Baseline, 2 months, 4 months, 6 months
measure: Safety evaluation
timeFrame: at 6 months
Secondary outcomes:
measure: Change of patient satisfaction questionnaire about keratin treatment
timeFrame: Baseline, 2 months, 4 months, 6 months
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University
Study officials:
affiliation: Faculty of Medicine, Sohag University, Egypt
name: Amr Abdelhamed, MD
role: PRINCIPAL_INVESTIGATOR
References: