CTRI/2026/02/103260尚未招募不适用
A Baseline-Controlled Clinical Study to Evaluate the Efficacy and Tolerability of a Test Product in Female Trial participants with Facial Melasma over 16 Weeks
CATALYSIS S.L.,1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年2月16日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
This is an interventional, baseline-controlled, single-center study to evaluate the efficacy and tolerability of a test product in female participants with facial melasma. Participants will be followed for approximately 17 weeks, including screening and washout, with six study visits. Assessments will be conducted at baseline and at Weeks 4, 8, 12, and 16. At Week 12, approximately 50% of participants will discontinue the test product while the remaining will continue until Week 16 to assess maintenance of effect.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 25.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Female
入选标准
- •Female participants aged 25 to 60 years at the time of screening.
- •Participants in general good health, as determined by medical history and dermatological examination.
- •Participants with clinically diagnosed mild to moderate facial melasma, as assessed by the investigator.
- •Participants with Fitzpatrick skin phototypes III to VI.
- •Participants who have not used topical or systemic depigmenting, skin-lightening, or irritating products on the face within 7 days prior to baseline.
- •Participants willing to discontinue use of other facial skincare products during the study, except the test product and permitted basic products as advised by the investigator.
- •Participants without active facial dermatological conditions (e.g., severe acne, wounds, infections) that could interfere with study assessments.
- •Participants willing to avoid facial cosmetic or dermatological procedures during the study period.
- •Participants willing to avoid excessive sun exposure and follow sun-protection advice throughout the study.
- •Participants willing and able to comply with study procedures and scheduled visits.
- •Participants who provide written informed consent and agree to photographic documentation for study purposes.
排除标准
- •Participants with severe melasma or other facial dermatological conditions that may interfere with study evaluations.
- •Participants who are pregnant, breastfeeding, or planning pregnancy during the study period.
- •Participants with a known hypersensitivity or allergy to any component of the test product.
- •Participants who have undergone facial cosmetic or skin-lightening procedures within 7 days prior to baseline.
- •Participants currently using or having recently used oral photosensitizing medications or phototherapy within 7 days prior to baseline.
- •Participants who have received systemic corticosteroids, immunosuppressive therapy, or antiepileptic drugs within the past 6 months.
- •Participants with photosensitivity disorders or chronic facial dermatoses.
- •Participants who have participated in another clinical trial involving an investigational product within 3 months prior to screening.
- •Participants with psychological, cognitive, or language limitations that may affect informed consent or study compliance.
- •Participants unable to undergo standardized photography or assessments as required by the study.
研究者
Dr Mukta Sachdev
MS Clinical Research Pvt. Ltd
研究点 (1)
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