Clinical study to evaluate the safety and efficacy of a cream in reducing skin pigmentation in healthy pregnant females and lactating females with Mild to Moderate Melasma.
- Conditions
- Health Condition 1: L989- Disorder of the skin and subcutaneous tissue, unspecified
- Registration Number
- CTRI/2022/08/044646
- Lead Sponsor
- Zydus Wellness Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
1)Sex: Females, either of the following
a.Healthy pregnant females (1st and 2nd trimester â?? 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.
2)Subjects with mild to moderate melasma determined by Melasma Area and Severity Index (MASI) score.
3)Subjects having at least 2 hyperpigmentary spots on the face.
4)Atleast 10 subjects with hypopigmentation along with melasma and at least 2 hyperpigmentary spots on the face.
5)Subjects who have a history of delivery within 42 weeks (applicable for post-pregnant females only).
1)Subjects who have pigmentation due to any other reason than exposure to UV light like result of hormonal changes, freckles.
2)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.
3)Subjects having history of diabetes, acute cardiac and circulatory diseases, HIV, hepatitis.
4)Participation in a similar clinical study within the previous 90 days.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1)Dermatological evaluation of the severity of melasma using Melasma Area and Severity Index (MASI) Score <br/ ><br>2)Evaluation of skin hyperpigmentation using Mexameter <br/ ><br>Timepoint: Baseline, Week 4, Week 12, Week 20
- Secondary Outcome Measures
Name Time Method Dermatological evaluation of skin radiance using modified Griffiths Scale.Timepoint: Baseline, Week 4, Week 12, Week 20;Evaluation of dark spot /blemishes /hypopigmentary spots using Chromameter.Timepoint: Baseline, Week 4, Week 12, Week 20;Evaluation of skin pigmentation /melasma /hypopigmentation by image analysis.Timepoint: Baseline, Week 4, Week 12, Week 20;Evaluation of uneven skin tone using Felix Von Luschan Skin colour chart.Timepoint: Baseline, Week 4, Week 12, Week 20;Photographs by VISIA CRTimepoint: Baseline, Week 4, Week 12, Week 20;Subject Satisfaction Questionnaire and Product Response Index (Perception about Product).Timepoint: Baseline, Week 4, Week 12, Week 20