Efficacy and Safety of Millet Seed Extract in the Treatment of Telogen Effluvium in Female Patients: A Randomized, Double-Blind, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Telogen and Anagen Hair Densities measured by Dermoscopy-Assisted Phototrichogram
研究概览
简要总结
This is a randomized, double-blind, controlled clinical trial investigating the efficacy and safety of millet seed extract capsules in treating telogen effluvium in female patients. The study will recruit 60 female participants with telogen effluvium who will be randomly assigned to receive either millet seed extract capsules (containing 420 mg millet seed extract, 200 mcg biotin, 6 mg L-cystine, and 27.48 mg vitamin B5) twice daily or Biotin forte capsules (5 mg biotin) once daily for 12 weeks. The primary outcome will measure changes in telogen and anagen hair densities using dermoscopy-assisted phototrichography. Secondary outcomes will assess patient satisfaction and unwanted body hair growth. Safety will be monitored throughout the study period at Cairo University's dermatology clinic.
详细描述
Telogen effluvium is characterized by diffuse hair shedding that significantly impacts quality of life. Millet seed extract, rich in bioactive compounds including miliacin, offers a promising natural treatment approach. This 12-week randomized, double-blind, controlled trial will recruit 60 female patients with telogen effluvium at Kasr Al Ainy, Cairo University. Participants will be randomly assigned to receive either millet seed extract capsules (420 mg millet seed extract, 200 mcg biotin, 6 mg L-cystine, 27.48 mg vitamin B5 twice daily) or biotin forte capsules (5 mg once daily). Primary outcome measures include telogen and anagen hair densities assessed by dermoscopy-assisted phototrichography at baseline and week 12. Secondary outcomes include patient satisfaction, unwanted body hair growth assessment, and Dermatology Life Quality Index scores. Safety will be monitored throughout the study period with adverse event reporting. The study includes female patients aged 18+ with clinically and trichoscopically confirmed telogen effluvium and hair shedding degree of 4 or higher on the Sinclair scale, excluding those with pregnancy, scalp diseases, or medication-induced hair loss.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Hair shedding degree of 4 or higher according to the Hair Shedding Visual Scale (Sinclair scale).
- •Diagnosis of telogen effluvium confirmed by a dermatologist after ruling out other causes of non-scarring alopecia (e.g., alopecia areata, androgenetic alopecia).
- •No use of topical or systemic hair loss treatments or oral hair growth supplements for at least 1 month prior to the study.
排除标准
- •Pregnancy or breastfeeding.
- •History of scalp diseases or conditions affecting hair growth like androgenic alopecia and alopecia areata.
- •Use of medications known to cause hair loss.
- •Any underlying medical condition that could interfere with the study.
- •Use of topical treatment in the last 3 month.
- •Use of systemic treatment in the last 3 month such as iron, biotin or any hair growth supplements.
- •Annemia or low serum level of ferritin.
研究组 & 干预措施
Millet Seed Extract Group
Participants in this group received Millet seed extract capsules containing 420 mg millet seed extract, 200mcg biotin, 6mg L-cystine, and 27.48 mg vitamin B5, taken orally twice daily for 12 weeks.
干预措施: Millet Seed Extract group (Dietary Supplement)
Control Group
Participants in this group received capsules containing 5mg of biotin once daily for 12 weeks.
干预措施: Biotin group (Dietary Supplement)
结局指标
主要结局
Change in Telogen and Anagen Hair Densities measured by Dermoscopy-Assisted Phototrichogram
时间窗: Baseline (Week 0) and Week 12 of treatment
Percentage change in telogen and anagen hair densities in the specified scalp area (external occipital protuberance region, 1 cm²) from baseline to week 12. Telogen and anagen densities will be calculated as the number of telogen/anagen hairs divided by total hair count in the selected area multiplied by 100. Measurements will be performed using dermoscopy-assisted phototrichogram (PTG) analysis with microphotographs taken on day 0 and day 3 of each assessment period
次要结局
- Patient Satisfaction with Treatment using Visual Analogue Scale (VAS)(Week 12 (End of Study))
- Unwanted Body Hair Growth Assessment(Baseline (Week 0) and Week 12 of treatment)
- Physician Global Assessment of Hair Improvement using Standardized Macrophotographs(Baseline (Week 0) and Week 12 (End of Study))
- Patient Global Assessment of Overall Hair Improvement(Week 12 (End of Study))
- Change in Dermatology Life Quality Index (DLQI) Score(Baseline (Week 0) and Week 12 (End of Study))
- Safety and Tolerability of Millet Seed Extract and Biotin Forte Capsules(Throughout the 12-week treatment period at Baseline (Week 0), Week 6, and Week 12)
研究者
heba ahmed abdelgayed ibrahim
Lecturer of Dermatology
Kasr El Aini Hospital