A PROSPECTIVE, RANDOMIZED AND OPEN LABEL STUDY TO COMPARE EFFICACY AND SAFETY OF TOPICAL GLUTATHIONE (2%) WITH TOPICAL TRANEXAMIC ACID (3%) IN ADULT MELASMA PATIENTS
Phase 4
- Conditions
- MELASMA
- Registration Number
- JPRN-UMIN000050940
- Lead Sponsor
- DEPARTMENT OF PHARMACOLOGY, GOVERNMENT MEDICAL COLLEGE AMRITSAR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Not provided
Exclusion Criteria
Patients refusing to give written informed consent Hypersensitivity to test drugs Pregnancy and lactation Any major comorbidities Hormonal medication 3 months prior to study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of efficacy of topical glutathione (2%) in comparison to topical tranexamic acid (3%) through evaluation by Modified Melasma Area Severity Index at baseline, 30, 60 and 90 days of study (mMASI) and Physician Global Assessment (PGA) scores at 30, 60 and 90 days of study
- Secondary Outcome Measures
Name Time Method Evaluation of safety by documenting proportion of adverse effects in each group at 30, 60 and 90 days of study Evaluation of quality of life by Melasma Quality of Life Index (MELASQOL) at baseline and 90 days of study