Efficacy and Safety of Keratin Hair Therapy on the Health of Hair and Scalp
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change of hair shedding using the Visual analogue scale (VAS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The participants, investigator and the outcome assessor will be blinded as regards the outcome measures evaluation
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change of hair shedding using the Visual analogue scale (VAS)
时间窗: Baseline, 2 months, 4 months, 6 months
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.
Change of hair morphology using trichoscope
时间窗: Baseline, 2 months, 4 months, 6 months
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.
Change of hair morphology using Transmission Electron Microscopic examination
时间窗: Baseline, 2 months, 4 months, 6 months
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
Safety evaluation
时间窗: at 6 months
to detect any side effects that will be reported either by the patient or by the physician.
次要结局
- Change of patient satisfaction questionnaire about keratin treatment(Baseline, 2 months, 4 months, 6 months)
研究者
Amr Abdelhamed
Associate professor, Department of Dermatology
Sohag University