Oral Isotretinoin in Melasma a Randomized Controlled Trial
- Registration Number
- NCT06201624
- Lead Sponsor
- Zagazig University
- Brief Summary
Melasma is a common refractory acquired hyperpigmentation of the skin having a serious impact on patients' quality of life. Melasma is challenging to treat. Treatment is often a multimodality approach. Due to the attached psychological and social stress, it is important to counsel patients with melasma adequately about the chronicity of the disease, the impo...
- Detailed Description
Melasma has a significant impact on the quality of life and self-esteem of those affected. Darker skin photo types e.g. Egyptians have excess potential to develop melasma.
Melasma is a chronic and challenging condition to manage. Previous treatment modalities have been unsatisfactory.
...
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- Age between 18 and 50 years
- Patients complaining of melasma.
- Patients with all types of melasma (epidermal, dermal and mixed)
- Sexually active women who is willing to follow at least 2 types of contraceptive methods during study period
- Patients with skin type I-V
- Pregnant or nursing women.
- Women on any concurrent therapy for melasma.
- Patients that are using any therapy for melasma for the last 45 days.
- Patient with abnormal liver function test or lipid profile.
- Patients with allergy or hypersensitivity to the assigned drugs.
- Women not willing to follow contraceptive methods at time of study.
- Patients on facial treatments or photosensitizing drugs within previous 6 months.
- Patients with back or joint pain.
- Patients with pre-existing or dormant dermatologic disease on the face that could interfere with the outcome of the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Kligman Formula arm Triple combination formula patients will receive topical triple combination formula at night everyday over the affected areas for 3 months Isotretinoin Isotretinoin patients will receive oral isotretinoin (1 mg/kg/day) for 3 months
- Primary Outcome Measures
Name Time Method Response to treatment three months Treatment efficacy will be assessed by the change in disease severity measured in mMASI at the end of the treatment period, and the difference in the global appearance of melasma through standardized photographs using Global Aesthetic Improvement Scale (GAIS) using a five-point ordinal scale (1 = exceptionally improved appearance, 2 = very improved appearanc...
Time to complete clearance 12 weeks The duration taken till complete clearance will be assessed as well.
- Secondary Outcome Measures
Name Time Method Treatment tolerability 12 weeks Treatment tolerability will be assessed in terms of the side effects reported by the investigator or the patients in follow-up visits including but not limited to; facial erythema, scaling, a burning sensation, and cheilitis. Patients' compliance assessed by the percentage of patients withdraw from each arm of the study and the number of days per week the pa...
Quality of life index 12 weeks The change in patients' quality of life using the difference between results of "Melasma Quality of Life Index" at baseline and end of treatment.
Trial Locations
- Locations (1)
Dermatology department, Zagazig University Hospitals, Faculty of Medicine, Zagazig University
🇪🇬Zagazig, Select Region, Egypt