Effect of application of cream with skin peeling compared to cream alone in patients of facial pigmentation.
- Conditions
- Health Condition 1: L811- Chloasma
- Registration Number
- CTRI/2019/07/020372
- Lead Sponsor
- OT APPLICABLE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Patients with modified MASI score >5.
2. Patients in general good health.
3. Females of childbearing age will be on a reliable form of contraception during the course of treatment other than oral contraceptive pills or hormone intrauterine device.
4. Patients must be willing to sign consent, answer questionnaires, and comply with all clinical visits, and use sunscreen and sun-protection measures.
5. Patients must be willing to not apply other treatment options for melasma during the course of the study.
1. Patients with known allergy to any components of the peel.
2. Patients on any concurrent therapy, concurrent illness, active or recurrent herpes labialis, keloidal tendencies, unrealistic expectations.
3. Pregnant and willing to be pregnant women, nursing mothers.
4. Patients who cannot communicate with investigators or who are unlikely to cooperate.
5. Patients who have been treated for melasma with any topical therapy in past 2 weeks or chemical peel in past 4 weeks.
6. Patients who have used micro derma abrasion or facial laser treatments in the past 3 months.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Change in pigmentation as seen by the effect on mMasi score at week 0, 6 and 12 <br/ ><br>2.Change in quality of life as seen by the effect on MELASQOL score at week 0 and 12.Timepoint: 1.Change in pigmentation as seen by the effect on mMasi score at week 0, 6 and 12 <br/ ><br>2.Change in quality of life as seen by the effect on MELASQOL score at week 0 and 12.
- Secondary Outcome Measures
Name Time Method 1. Reduction in mean mMASI score from week 0 to week 6 and 12. <br/ ><br>2. Improvement in MELASQOL score from week 0 to week 12. <br/ ><br>3. Adverse event assessment every 2 weeks till the end of treatment.Timepoint: 1. Reduction in mean mMASI score from week 0 to week 6 and 12. <br/ ><br>2. Improvement in MELASQOL score from week 0 to week 12. <br/ ><br>3. Adverse event assessment every 2 weeks till the end of treatment.