Evaluation of efficacy, safety, and tolerance of a liposomal based cocktail of topical depigmenting agents for treatment of epidermal melasma
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
- 主要终点
- To evaluate improvement in modified Melasma Area and Severity Index (mMASI) score.
研究概览
简要总结
This study is to compare the efficacy and tolerability of a novel test product in the management of epidermal melasma. This study is designed as a prospective, single arm, open label study. A total of 40 subjects, fulfilling the inclusion and exclusion criteria, will be enrolled in the study. All enrolled subjects will receive the test product and will be followed at Baseline (Month 0), Month 1, Month 2, Month 3, and Month 4.
The efficacy and tolerability parameters will be assessed by various methods, including dermatological examination, digital examination (Visage-LS), and subject self-assessment, for the entire study period.
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
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Inclusion criteria: 1)Female and male patients, from 18-45 years of age with epidermal melasma.
- •Subjects with mild to moderate epidermal melasma.
- •Participants who can provide a written informed consent and photo consent form.
- •Participants who are willing to follow up for four visits over a period of 12 weeks.
- •Participants who are able and willing to follow all the study procedures including abstinence from usage of any OTC product related to face applications.
- •Participants who are willing to be clinically photographed as per protocol.
排除标准
- •Exclusion criteria: 1)Patient who is not willing to participate in the study.
- •Patients who are using other pigment reduction creams (except sunscreen and a base moisturiser).
- •Subjects with other dermatological disorder of the face that may interfere with the study evaluation (Acne, DPN, Seborrheic melanosis) 4)Subjects with known hypersensitivity to any of the study compunds or constituents.
- •Subjects who are expected to be exposed to the triggering factors (excessive sun exposure, UVB photo therapy, use of OCPs).
- •Patient who has received facial procedures like dermabrasion, chemical peels, or laser procedures within the last 1 month.
- •Any patient as per investigator’s opinion is unfit for participation in the study.
- •Pregnant / lactating females.
结局指标
主要结局
To evaluate improvement in modified Melasma Area and Severity Index (mMASI) score.
时间窗: Month 0, Month 1, Month 2, Month 3
次要结局
- Mean change in mMASI scores.(Month 0 to Month 3)
- Improvement in Tone Homogeneity(Month 0 to Month 3)
- Mean change in Melanin & Erythema Indices.(Month 0 to Month 3.)
- Subject perceived efficacy by Patient Global Assessment.(Month 3)
- Change in subject’s quality of life by Melasma Quality of Life survey.(Month 1 & 3)
研究者
Dr Shilpa Kanathur
Bangalore Medical College & Research Institute, Bengaluru