A randomized, double blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of Plant Keratin in androgenic alopecia subjects.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Reduction in hair shedding in Comb test and Hair pull test
研究概览
简要总结
Androgens play a crucial role in regulating the scalp and body hair growth.The androgens can significantly contribute to the specific pattern hair loss called androgenetic alopecia (AGA). AGA, commonly known as the male pattern baldness is a predominant form of hair loss affecting both male and female genders worldwide. Although the specific mechanism of AGA is not completely understood, it is reported that androgen mediated androgen receptor (AR) activation leads to the hair miniaturization resulting in hair loss.
Plant keratin is a protein blend from different plant sources to simulate the amino acid composition of animal keratin. The first-of-its-kind proprietary formulation of plant proteins is a blend of extracts from Trigonella foenum-graecum seeds and Pisum sativum seeds. The plant keratin is in powder form with characteristic odour and taste and a standardized protein content of 58-60%.
The findings from the present study suggest that plant keratin possess the anti-androgenic property that can contribute as a DHT-blocker in conditions like AGA. Further, the plant keratin supplementation may stimulate follicular melanogenesis in the anagen phase to trigger hair regrowth
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 20.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects in general good health.
- •Subjects aged 20-50 years (both the ages inclusive).
- •Selection of AGA subjects based on Norwood Hamilton scale (male) and Ludwig scale (female).
- •Subjects willing to give written informed consent and willing to abide by and comply with the study protocol.
- •Hair density of greater than 100 and less than 200 hair follicles per square cm as per Trichoscan measurement.
- •The subjects who agree to refrain from using hair dye/hair color during the study period.
排除标准
- •Subjects who have undergone hair growth treatment within 3 months before screening into the study.
- •Subjects having any active scalp disease which may interfere with the study dermatologists judgment.
- •Subjects who have taken chemotherapy for cancer in the 6 months before the start of the study or have a plan to do treatments during the study.
- •Subjects who have a history of alcoholism, smoking, crash dieting, and/ or psychiatric disorders including trichotillomania.
- •Subjects who have had hair transplants, who have taken pharmaceutical products which cause hirsutism (ex.
- •phenytoin) and finasteride for androgenic alopecia, under medical treatment for hair problems.
- •A known history or present condition of allergic response/hypersensitivity to any cosmetic ingredients and pharmaceutical products.
- •Subjects on oral medications, undergoing any chemical hair salon treatment-straightening / perming/colour/ henna which will compromise the study.
- •Subjects with chronic illness which may influence the cutaneous state.
- •Subjects who are pregnant or lactating or nursing as established with medical history.
- •Menopausal female subjects as determined by medical history.
- •Subjects with any history of underlying uncontrolled medical illness including diabetes mellitus, hypertension, HIV, hepatitis, severe anemia, serious disorders of heart and respiratory apparatus, or any other serious medical illness.
结局指标
主要结局
Reduction in hair shedding in Comb test and Hair pull test
时间窗: Baseline, Week 4, Week 8, Week 12
次要结局
- Hair density
- Thickness(Baseline, Week 12)
- A/T ratio- (Trichoscan analysis)(Baseline, Week 12)
- Hair assessment for smoothness, shine
- Scalp & hair health assessment(Baseline, Week 12)
- Digital Photography(Baseline, Week 12)
- Perceived self-assessment questionnaire (Hair growth index scale)(Baseline, Week 12)
- Norwood Hamilton scale(Baseline, Week 12)
- Ludwig scale(Baseline, Week 12)
研究者
Dr Sunil Kumar S
Vagus Super Specialty Hospital