A Prospective, Open-labeled, Clinical Study to evaluate the efficacy and safety of a Skin Lightening Soap for the treatment of Hyper Pigmentation in adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Changes in score of the Melasma area and severity index (MASI) (Baseline to EOT) Mexameter analysis (Melanin,erythema contents) (Baseline to EOT) Chromameter (L,a and b values) (Baseline to EOT) To assess the efficacy of skin lightening soap for the treatment of hyper pigmentation in adults in comparison to base line by following parameters(Baseline to EOT)
研究概览
简要总结
A Prospective, Open-labeled, Clinical Study to evaluate the efficacy and safety of a Skin Lightening Soap for the treatment of hyper pigmentation in adults.
Primary Objective: To assess the efficacy of „Skin Lightening Soap‟ for the treatment of hyper pigmentation disorders in adults.
Secondary Objective: To evaluate the safety of Skin Lightening Soap‟ for the treatment of hyper pigmentation disorders in adults.
Primary endpoints Changes in score of the Melasma area and severity index (MASI) (Baseline to EOT)
Mexameter analysis (Melanin,erythema contents) (Baseline to EOT)
Chromameter (L,a and b values) (Baseline to EOT)
To assess the efficacy of skin lightening soap for the treatment of hyper pigmentation in adults in comparison to base line by following parameters(Baseline to EOT)
Dermatologists assessment (Baseline to EOT) Shade card assessment(Baseline to EOT)
Secondary Endpoints Physician global improvement assessment scores at Day 1 to Day 90
skin whitening by subject self assessment during the visits (Baseline to EOT) - Patient satisfaction using grading scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Males and females of age group 18-60 years Subjects who are willing to give written informed consent.
- •Subjects with Fitzpatrick Skin types II to IV Subjects with hyper pigmentation disorders such as Melasma and lentigo (mild to moderate).
- •Patient is willing and able to comply with all trial requirements.
排除标准
- •Having major treatment, including topical hydroquinone or tretinoin, cryotherapy, electro-surgery, trichloroacetic acid application, laser or intense pulsed light, in the 3 months before the beginning of the study Past history of allergy to whitening cosmetic products Past history of atopic dermatitis Habit of going to the tanning salon or frequent sun exposure longer than 4 hours per day Present history of mental diseases Previous participation in a clinical trial within 6 months.
- •Pregnant or lactating woman Certain medications that may interfere with the study medication (these will be identified by the study Investigator).
结局指标
主要结局
Changes in score of the Melasma area and severity index (MASI) (Baseline to EOT) Mexameter analysis (Melanin,erythema contents) (Baseline to EOT) Chromameter (L,a and b values) (Baseline to EOT) To assess the efficacy of skin lightening soap for the treatment of hyper pigmentation in adults in comparison to base line by following parameters(Baseline to EOT)
时间窗: Baseline to end of the treatment | (Day 90)
Dermatologists assessment (Baseline to EOT) Shade card assessment(Baseline to EOT)
时间窗: Baseline to end of the treatment | (Day 90)
次要结局
- Physician global improvement assessment scores.(Melasma Quality of life questionnaire before and after the treatment. (Baseline to EOT) To study the performance of the skin lightening soap in imparting the)