TCTR20221111003已完成2 期
The efficacy and safety of pure Saw palmetto (Serenoa repens) extract lotion in Androgenetic Alopecia: An Open-labelled Quasi Experimental Clinical Study
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 18
研究概览
简要总结
The study showed that pure Saw Palmetto Extract lotion effectively treated male Androgenetic Alopecia. Over 12 weeks, it significantly increased hair count, boosted terminal hair growth, and decreased vellus hair. Participant satisfaction improved notably, with most expressing high satisfaction by study's end. Dermatologists' photographic assessments confirmed increased hair density. The treatment was safe, with only one minor, temporary side effect reported.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 30 Years 至 50 Years（—）
- 性别
- Male
入选标准
- •1. Males with Mild to Moderate Androgenetic Alopecia (Norwood-Hamilton type I,II, III and IIIv)
- •2. Age 30-50 years
- •3. Participants who are not currently using systemic or topical drugs for hair loss
- •4. Participants who are willing to use the same shampoo, refrain from change in hair style, and refrain from hair dyeing during the study
- •5. Participants who are willing to refrain from any therapy affecting hair during the study
- •6. Participants who are willing to have photographs of the treated area taken.
- •7. Participants who are willing to follow the treatment schedule and post treatment follow-up
- •8. Participants who are not willing to participate on other studies during the study period
排除标准
- •1. Females with Androgenetic Alopecia
- •2. Participation in a study of another device or drug within one month prior to enrollment or during the study.
- •3. Coexisting systemic diseases e.g., Suffering from significant concurrent illness, such as cardiac disorders, diabetes (type I or II), uncontrolled hypertension, symptomatic hypotension, hyperthyroidism, hypothyroidism, or pertinent neurological disorders.
- •4. Suffering from serious medical conditions that could adversely affect hair loss such as immunosuppression/immune deficiency disorders (including HIV), history of cancer or having/undergoing any form of treatment for active cancer, connective tissue disorder, inflammatory bowel disease
- •5. Scars or ulcers on the scalp
- •6. Suffering from any active dermatological condition in the treated area such as scalp atrophy, which in the opinion of the investigator might interfere with clinical evaluation.
- •7. Having hair weave or tattooing of the alopecia area.
- •8. Hair loss other than from Androgenetic Alopecia such as alopecia areata, scarring alopecia
- •9. Hair transplantation within 6 months
- •10. Use of following systemic or topical medications that could affect hair loss within 6 months within the past 6 months
- •-Prescription or over-the-counter systemic or topical treatment specific for androgenic alopecia (such as minoxidil, finasteride, dutasteride).
- •-5alpha-reductase inhibitors for prostate conditions (e.g., benign prostate hyperplasia, prostate cancer) and hormone replacement therapy for transgenders
- •-Medications with anti-androgenic properties (cyproterone, spironolactone, ketoconazole, flutamide, progesterone, and bicalutamide)
- •-Medications that can potentially cause hypertrichosis (e.g., cyclosporine, diazoxide, phenothiazines, zidovudine, tamoxifen, carpronium chloride),
- •-Medications that can potentially cause alopecia such as oral glucocorticoids, lithium, phenothiazines, tamoxifen.
- •-Botanicals/neutraceuticals for hair growth
- •-Steroids - systemic steroids for more than 14 days (e.g., corticosteroids, anabolic steroids) or topical steroids in the area of hair loss.
研究者
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