Oral Isotretinoin in The Treatment of Melasma A Randomized Controlled Clinical Trial

ZU-IRB#10462/26-2-2023

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 importance of photoprotection, and the role of hormones in disease persistence before embarking on therapeutic correction. So in this study, we are exploring the efficacy of oral isotretinoin for treating melasma.

2023-03-01

2024-01-31

2024-05-31

Recruiting

Early phase I

40

Inclusion Criteria: 1. Age between 18 and 50 years 2. Patients complaining of melasma. 3. Patients with all types of melasma (epidermal, dermal and mixed) 4. Sexually active women who is willing to follow at least 2 types of contraceptive methods during study period 5. Patients with skin type I-V Exclusion Criteria: 1. Pregnant or nursing women. 2. Women on any concurrent therapy for melasma. 3. Patients that are using any therapy for melasma for the last 45 days. 4. Patient with abnormal liver function test or lipid profile. 5. Patients with allergy or hypersensitivity to the assigned drugs. 6. Women not willing to follow contraceptive methods at time of study. 7. Patients on facial treatments or photosensitizing drugs within previous 6 months. 8. Patients with back or joint pain. 9. Patients with pre-existing or dormant dermatologic disease on the face that could interfere with the outcome of the study

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}

2024-01-11