An open-label, single-arm study to evaluate efficacy and safety of a cream in reducing skin pigmentation in healthy pregnant female (1st and 2nd trimester) and lactating female (post pregnancy mother having 0 month to 18 months old baby) subjects with Mild to Moderate Melasma.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1)Dermatological evaluation of the severity of melasma using Melasma Area and Severity Index (MASI) Score
研究概览
简要总结
The potentialsubjects will be screened as per the inclusion and exclusion criteria onlyafter obtaining written informed consent from the subjects.
There are total 5 visits in the study i.e.
· Visit 01: Screening Visit (within 30 days prior to day01)
· Visit 02: Enrolment (Week 1, Day 01)
· Visit 03: Evaluation phase (Week 4, Day 28 ± 2 days)
· Visit 04: Evaluation phase (Week 12, Day 84 ± 2 days)
· Visit 05: Evaluation phase and End of the study (Week20, Day 140 ± 2 days)
Beforeentering the facility, at security check-post, subjects will be asked forpre-entry scrutiny check for COVID-19 symptoms. Study can be conducted inmultiple batches (set of subjects) in order to follow the norms of covid-19restrictions.
Instrumentalassessment, dermatological assessments and questionnaires will be assessed.Photographs will be taken using VISIA-CR. Images will be analyzed using ImagePro Software/3D analysis system. Safety will be assessed throughout the studyby monitoring of adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 22.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Sex: Females, either of the following a.Healthy pregnant females (1st and 2nd trimester – preferably first half of the 2nd trimester).
- •b.Post-pregnant females (post pregnancy mother having 0 month to 18 months old baby) at the time of consent.
- •Subjects with mild to moderate melasma determined by Melasma Area and Severity Index (MASI) score.
- •Subjects having at least 2 hyperpigmentary spots on the face.
- •Atleast 10 subjects with hypopigmentation along with melasma and at least 2 hyperpigmentary spots on the face.
- •Subjects who have a history of delivery within 42 weeks (applicable for post-pregnant females only).
排除标准
- •Subjects who have pigmentation due to any other reason than exposure to UV light like result of hormonal changes, freckles.
- •Subjects with skin disease (e.g., moderate to severe acne vulgaris face or nodulocystic acne, psoriasis, atopic dermatitis or any other condition as per Investigators discretion), which would interfere with the assessment area.
- •Subjects having history of diabetes, acute cardiac and circulatory diseases, HIV, hepatitis.
- •Participation in a similar clinical study within the previous 90 days.
结局指标
主要结局
1)Dermatological evaluation of the severity of melasma using Melasma Area and Severity Index (MASI) Score
时间窗: Baseline, Week 4, Week 12, Week 20
2)Evaluation of skin hyperpigmentation using Mexameter
时间窗: Baseline, Week 4, Week 12, Week 20
次要结局
- Evaluation of dark spot /blemishes /hypopigmentary spots using Chromameter.(Baseline, Week 4, Week 12, Week 20)
- Dermatological evaluation of skin radiance using modified Griffiths Scale.(Baseline, Week 4, Week 12, Week 20)
- Evaluation of uneven skin tone using Felix Von Luschan Skin colour chart.(Baseline, Week 4, Week 12, Week 20)
- Evaluation of skin pigmentation /melasma /hypopigmentation by image analysis.(Baseline, Week 4, Week 12, Week 20)
- Subject Satisfaction Questionnaire and Product Response Index (Perception about Product).(Baseline, Week 4, Week 12, Week 20)
- Photographs by VISIA CR(Baseline, Week 4, Week 12, Week 20)