To study Quality of Life and untoward effects of TRI-LUMA Cream in women with melasma on face.
Phase 4
Completed
- Registration Number
- CTRI/2018/01/011403
- Lead Sponsor
- Galderma India Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 33
Inclusion Criteria
Participants with moderate to severe melasma on the face.
Childbearing potential patient with highly effective contraceptive methods
Willing to avoid unusual sun exposure as far as possible for the entire study duration.
Exclusion Criteria
Patients with prior history of mometasone based triple combination melasma therapy or under hormonal replacement therapy including usage of OC pills
If Patients were immunocompromised or were under immunosuppressive treatment, or had contraindications for corticosteroid treatment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Quality of life and Participant SatisfactionTimepoint: Day 0, 1 month, 2 months
- Secondary Outcome Measures
Name Time Method Clinical evaluation for in use toleranceTimepoint: Day 0, 1 month, 2 months;Clinical evaluation of skin atrophyTimepoint: Day 0, 1 month, 2 months;Instrumental evaluation for colorTimepoint: Day 0, 1 month, 2 months;Non-invasive Ultrasound biomicroscopy (UBM) of the skinTimepoint: Day 0, 1 month, 2 months;Percent Changes in MASI scoreTimepoint: Day 0, 1 month, 2 months;Subjective self-assessment for in use toleranceTimepoint: Day 0, 1 month, 2 months