A randomized double-blinded clinical study to evaluate the hair growth efficacy of CosmeRNA in female subjects
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- To evaluate the effectiveness of the test product in promoting hair growth in comparison to baseline determined by dermatological and instrumental assessment.
研究概览
简要总结
This study involves 46 female participants who meet the inclusion and exclusion criteria and have signed informed consent. During the screening visit (Visit 1), participants will undergo a dermatological evaluation to assess their eligibility, and those qualified will be instructed on the next visit schedule. Participants will be randomized into two groups and undergo various baseline assessments, including imaging and biopsy for select subjects. Follow-up visits will include treatment sessions and periodic assessments to track the progress of the study. Site application reactions will be monitored from Visit 2 to 19, with acclimatization at each visit and ongoing evaluations of treatment effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Female
入选标准
- •Subjects in the age group 30-50 years (both the ages inclusive).
- •Subjects complaining of hair fall and damage.
- •Subjects willing to give a written informed consent and willing to abide by and comply with the study protocol.
- •Subjects who agree to use regular shampoo throughout the study (shampoo without any hair growth ingredient).
- •Atleast 6 subjects, 3 subjects in each group willing to undergo Biopsy (Subjects who agree to participate in scalp biopsy have to acknowledge and understand of scalp biopsy procedure and potential risks.
排除标准
- •Subjects who have undergone any kind of hair growth treatment in the last 1 month.
- •Subjects having any active but controllable scalp disease which may interfere in the study assessments.
- •Subjects who have taken chemotherapy for cancer in the 6 months prior to the study start.
- •Subjects who have history of crash dieting and or psychiatric disorder including trichotillomania.
- •Subjects who have undergone hair transplant.
- •A known history or present condition of allergic response hypersensitivity to any topical or oral cosmetic pharmaceutical or neutraceutical product.
- •Subjects with chronic illness which may influence the cutaneous state.
- •Subjects who are pregnant or nursing (Self declared).
结局指标
主要结局
To evaluate the effectiveness of the test product in promoting hair growth in comparison to baseline determined by dermatological and instrumental assessment.
时间窗: Day 0, Day 2, Day 14, Day 28, Day 30, Day 42, Day 56, Day 58, Day 70, Day 84, Day 86, Day 98, Day 112, Day 114, Day 140, Day 142, Day 168, Day 170
次要结局
- To evaluate the overall safety of the test product(Day 0, Day 2, Day 14, Day 28, Day 30, Day 42, Day 56, Day 58, Day 70, Day 84, Day 86, Day 98, Day 112, Day 114, Day 140, Day 142, Day 168, Day 170)
研究者
Dr Mukta Sachdev
MS Clinical Research Pvt. Ltd