A study for the treatment of melasma which compares the effectiveness and side effects of metformin cream with triple combination cream which contains steroid plus hydroquinone plus retinoid skin lightening agents and tranexamic acid cream.
Phase 2
- Conditions
- Health Condition 1: L811- Chloasma
- Registration Number
- CTRI/2024/07/070009
- Lead Sponsor
- Dr Namitha P
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Patients willing to give informed consent.
2.Both male and female patients aged more than 18yrs
3.Patients with clinically diagnosed melasma.
4.Patients with melasma who have not applied any topical creams since two weeks/ who have not taken oral steroids since the last one month/ done any procedures like lasers/ chemical peels.
Exclusion Criteria
1. Pregnant and lactating women
2. Patients on oral contraceptives, phenytoin
3. Patients on renal dysfunction
4. Patients allergic to the medications under trial
5. Patients with acne vulgaris/ rosacea
6.Patients with facial hair (beard)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the efficacy of 30% metformin cream versus triple combination cream and 10 % tranexamic acid cream in the reduction of MASI (Melasma Area and Severity Index) score and its safety in the treatment of melasma.Timepoint: At 4 weeks, 8 weeks, 12 weeks follow up
- Secondary Outcome Measures
Name Time Method MASI score will be assessed at 4 weeks, 8 weeks and 12 weeks follow up along with simultaneous serial digital photographsTimepoint: At 4 weeks, 8 weeks, 12 weeks follow up