A Randomized, Single-Blinded, Parallel, Controlled Clinical Study to Evaluate the Efficacy and Safety of test regime in male participants with Androgenic alopecia.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- The primary objective is to evaluate & compare the efficacy of the test regime with the test serum along with placebo as per Trichoscan® measurement including growth rate & hair density (hair per cm2 of test area)
研究概览
简要总结
Theparticipants who satisfy the inclusion and exclusion criteria will be enrolledprior to the trial after obtaining the informed consent form. 135 healthy maleparticipants will be enrolled, so that 120 participants i.e. 40 in each group,complete the study. Selected participants will enter a washout period of twoweeks. During this period the participants will be instructed to discontinuethe usage of all hair care medications or topical products which is known tohave hair growth effects. Participants will be asked to visit the study centeron Day 1 for baseline assessments. Baseline assessment like dermatologicalassessments, Trichoscan imaging will be performed. This visit will also includeshaving of the test area. The subjects will have to visit the site on day 3 forthe phototrichogram assessment. Therewill be three groups. The selected subjects will be provided with the either ofthree regimes based on the randomization. The subjects will be instructed toapply (topical products)/consume (supplements) the test product for 8 months.The participants will be randomised and will be assigned to one of the threegroups:
1. Test regime- Customised regime includingtest serum
2. Test serum
3. Placebo
Participantswill be asked to visit the study center on Day 2 (visit-3). Follow-upassessments will be performed at M2, M4 M6 and M8 where each assessmentschedule will have 2 visits, 2 days apart (+2 days visit will done forTrichoscan imaging). This visit consists of Dermatological Assessment forSafety, Trichoscan® Imaging, Digital Imaging, Microscopic & DigitalImaging.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Male
入选标准
- •A willing participant must fulfill the following criteria to be eligible for participation in the study:
- •Male Patients aged 18 to 45 years with male pattern hair loss (Androgenetic Alopecia) of stage 2-4 as per Norwood scale.
- •Subjects willing to provide written informed consent, indicating that they thoroughly understand the purpose and procedures required for the study and are willing to participate in the study.
- •Patients willing to have a mark in the target area.
排除标准
- •A willing study participant will be excluded from the study, if any of the following criteria is noted:
- •Clinically relevant abnormal physical findings which could interfere with the aim of the study; in particular, skin damage such as skin abrasion, actinic keratosis or any abnormal findings in the scalp.
- •Clinically significant dandruff
- •Active unstable thyroid disease, including subjects on therapy for either hyperthyroidism or hypothyroidism unless their dose of thyroid medication has been stable for atleast 3 months.
- •Suspicion of malignancy, including prostate cancer.
- •Patients who had hair transplant surgery or hair weaving.
- •Patient who had light or laser treatment on the scalp.
- •History or evidence of hair loss other than Androgenetic Alopecia (e.g. due to auto-immune, endocrine, mechanical or infectious process or secondary to a scalp dermatological disorder).
- •Patients with active seborrheic dermatitis.
- •History of varicocele.
- •Clinically relevant abnormal laboratory values indicative of physical illness.
- •Ascertained or presumptive hypersensitivity to the active formulations or any of the excipients.
- •Patient with significant clinical relevant endocrinal, cerebrovascular, skin, pulmonary, haematological, immunological and cardiovascular disease could lead to safety risk.
- •Concurrent use of systemic corticosteroids, topical corticosteroids in the balding are studied, anabolic steroids, over-the-counter.
- •Use of the drugs with anti-androgenic properties within 6 months of study entry.
- •Patient had major surgery within 2 months prior to study entry, or who have not recovered from prior major surgery.
- •Participation in a drug research study within past 3 months.
结局指标
主要结局
The primary objective is to evaluate & compare the efficacy of the test regime with the test serum along with placebo as per Trichoscan® measurement including growth rate & hair density (hair per cm2 of test area)
时间窗: Baseline (month 0), month 2, month 4, month 6 & month 8
次要结局
- 1.To evaluate hair density within per cm2 of test area in comparison to baseline, month 2, month 4, month 6 & month 8 using instrumental and dermatological assessments(2.To evaluate and compare the hair thickness at baseline, month 2, month 4, month 6 and month 8 using Trichoscan®)