Observational Study to Evaluate Efficacy, Safety and Tolerability of Z-n-butylresorcinol in Patients with Melasma
- Conditions
- Melasma
- Registration Number
- CTRI/2015/04/005697
- Lead Sponsor
- Micro Labs Ltd
- Brief Summary
This study is Open Label,Single Arm, Observational Study to Evaluate Efficacy, Safety and Tolerabilityof 4-n-butylresorcinol in 50 subjects with Melasma. The study conducted at two sites inIndia. The primary outcome measures efficacy of 4-n-butylresorcinol in reducingmelasma and the secondary outcome measures safety and tolerability of 4-n-butylresorcinol bythe investigators. The total treatment period is 8 weeks
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 50
•Subjects with melasma who are either treatment naive or were not on any treatment for at-least 6 months •Subjects aged 18 and above years with melasma •Subjects with Epidermal type of melasma •Subjects with Fitzpatrick skin types III, IV and V •Subjects willing to apply sunscreen during the course of study •Subjects willing to return for all clinic visits and complete all study-related procedures.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluate the efficacy of 4-n-butylresorcinol in reducing melasma 4th week and 8th Week
- Secondary Outcome Measures
Name Time Method Evaluate safety of 4-n-butylresorcinol based on the adverse effects as mentioned by the patient and evaluated by the investigator. Assess tolerability of 4-n-butylresorcinol by the investigators
Trial Locations
- Locations (2)
Dr.B.R Ambedkar Medical college
🇮🇳Bangalore, KARNATAKA, India
Kempegowda Institute of Medical Sciences
🇮🇳Bangalore, KARNATAKA, India
Dr.B.R Ambedkar Medical college🇮🇳Bangalore, KARNATAKA, IndiaDrMadan MohanPrincipal investigator080-25476498derma_madanmohan@yahoo.co.in