CTRI/2022/10/046767尚未招募4 期
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Clinical Study to Evaluate the Efficacy and Safety of VISPO in Healthy Adult Male and Female Subjects Suffering with Mild to Moderate Androgenetic Alopecia.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Mean change in hair fall
研究概览
简要总结
This is a double blind, randomized (1:1:1:1), placebo controlled, parallel group, four arm study. Adult healthy subjects suffering from mild to moderate androgenetic alopecia (AGA) and meeting all inclusion and no exclusion criteria, after signing a written informed consent will be enrolled in the study. The subject will arrive at the study site in fasting state and blood samples will be collected for laboratory assessment. The subjects will visit their designated study site on 3 different occasions during the 12-week study duration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •l Healthy subjects, as determined by the investigator.
- •Presence of androgenetic alopecia In male: Norwood Hamilton Scale grade II to VA with vertex involvement.
- •In females: Sinclair scale for female pattern hair loss: Grade II to IV.
- •Agrees not to use products with the same end benefit during the entire study period.
- •Willingness to be photographed and provide consent for photographic release.
- •Subjects who agree to refrain from using hair dye / hair colour/ hair treatment (like perming, straightening etc.) during the study period.
排除标准
- •Subjects having conditions like alopecia areata, alopecia totalis, alopecia universalis and alopecia diffusa.
- •Scarring of the scalp or any other condition or disease of the scalp or hair, including diseases of the hair shaft and inability to discontinue use of hair weaving.
- •Subjects with history of any chronic health conditions, Endocrine abnormalities, Pychiatric illness, Drug abuse, smoking, abuse/addiction to alcohol, Bariatric surgery/ eating disorder such as bulimia or binge eating.
- •History of any other major surgery
- •Use of the following during the 6 months prior to screening: Minoxidil (oral or topical) Drugs with anti-androgenic properties (e.g., cyproterone acetate, spironolactone, ketocnazole, flutamide, bicalutamide).
- •Cimetidine cannot be used during the study but is not an excluded drug when used during the previous 6 months.
- •Drugs potentially causing hypertrichosis (e.g., cyclosporine, diazoxide, phenytoin psoralens), Anabolic steroids, Lithium and phenothiazines.
- •Use of systemic steroids for more than 14 days within the past 2 months prior to enrolment in the study.
- •Use of isotretinoin, light therapy, radiation to the scalp, or chemotherapy within the past year.
- •Subjects allergic to herbal products or any component of the study product
- •Any clinically significant systemic or cutaneous disease, which may interfere with study treatments or procedures.
- •Subjects who have had hair transplant.
- •Subjects on any medical treatment either systemic or topical which may interfere with the performance of the study treatment (presently or in the past 1 month).
- •Menopausal female subjects as determined by medical history 10.Known HIV or Hepatitis B positive or any other immuno-compromised state.
结局指标
主要结局
Mean change in hair fall
时间窗: Day 1, Day 56 and Day 112
次要结局
- Over all Safety(Day 1, Day 56 and Day 112)
- Mean change in Hair density and Questionnaire based assessments(Day 1, Day 56 and Day 112)
- Mean change in Biomarkers(Day 1,Day 112)
研究者
研究点 (1)
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