12-week Evaluation of the Efficacy and Tolerability of a Scalp Serum Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 试验地点
- 1
研究概览
简要总结
The goal of this clinical trial is to evaluate the efficacy and tolerability of a scalp serum on 60 healthy females aged 25 to 65 years with Fitzpatrick skin phototypes I-VI and with mild to moderate thinning hair. The primary objective is to evaluate if the scalp serum can achieve fuller and thicker hair with fewer signs of hair shedding from baseline. The second objective is to evaluate if the scalp serum enhances scalp health including optimizing the pH and supporting microbiome at Week 4 and Week 12 compared to baseline (post-washout period).
Subjects will apply a scalp serum once-daily to wet or dry hair in either the morning or evening for 12 weeks. Prospective Candidates will attend a Pre-Study Visit (PSV) at the lab to be consented. After being accepted onto the study, Volunteers will be told to stop the use of all products on their scalp and hair (shampoo, conditioner, oils, dyes etc.) other than the Sponsor-provided Ancillary Products (APs) and their regularly used, non-medicated styling products for the seven (7) days prior to Visit 1/Baseline (V1/BL) and for the duration of the study. Subjects will return to clinic for study visits at weeks 4, 8, and 12.
详细描述
At V1(baseline), Subjects will have their hair combed and the shed hairs collected. They will then report to a Dermatologist, who will make BL evaluations of Redness, Dryness, Flaking, and Bumps. Subjects will then be asked to rate the Itching, Burning, and Stinging of their scalp. A Technician will clip an area of hair and take photographs of the area for trichoscopy analysis. Photographs of the Subject's scalp with hair parted down the middle will also be taken. Ultrasound, Laser Doppler, pH, and Moisture measurements will be taken from their scalp. Subjects will then have microbiome samples collected from their scalp via swabbing, and a subset of five (5) Subjects will have 2mm punch biopsies collected from their scalp behind one of their ears. A Technician will provide the Subject with the Investigational Product (IP), Subject Instructions (including treatment instructions), and a Daily-Use Diary before applying the product under supervision. Subjects will then complete a self-assessment questionnaire (SAQ) before their visit ends.
Subjects will report to the study site for Visit 2 (V2), approximately 48 hours after their BL appointment (BL +2D) and will have the clipped area of their scalp photographed again for trichoscopy.
At Visit 3 (V3), Subjects will report to the study site approximately 4 weeks (W4) after their initial BL visit. At this visit, the same measurements, photographs, and assessments will be performed as at the BL visit, except for biopsy collection. Subject's IP will be weighed, their Daily-Use Diary will be reviewed, and they will apply the IP under supervision before completing an SAQ. After these procedures, the Subjects will leave the study site.
Subjects will report to the study site for Visit 4 (V4), approximately 48 hours after their W4 appointment (W4 +2D) and will have the clipped area of their scalp photographed again for trichoscopy.
At Visit 5 (V5), Subjects will report to the study site approximately 8 weeks (W8) after their initial BL visit. At this visit, the same dermatological and Subject assessments, as well as photography and shedding analysis, will be performed as at the BL visit. No instrumental measurements, microbiome swabbing, or biopsy collection will be performed at this visit. Subject's IP will be weighed, their Daily-Use Diary will be reviewed, and they will apply the IP under supervision before completing an SAQ. After these procedures, the Subjects will leave the study site.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •biological females
- •25 to 65 years old
- •Fitzpatrick Skin Type I - VI
- •Mild to moderate thinning hair (Ludwig score of I-1 through I-4)
排除标准
- •Active scalp disease
- •Prior use of medicated shampoos or topical scalp treatments within 12 months.
- •Diagnosis of female pattern hair loss or other alopecia disorders, or use of medications, supplements, or procedures known to affect the hair growth cycle.
- •Pregnancy or breastfeeding, planned pregnancy during the study period