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.
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. Oral isotretinoin is a potential treatment modality for melasma that has not been investigated yet. In this study we aim to evaluate the efficacy and the tolerability of oral isotretinoin in the treatment of melasma and to compare its efficacy and tolerability with the current gold standard "topical triple combination formula"
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
40
Patients will receive 1mg/kg/day for 3 months
Patients are instructed to apply the triple combination formula at night daily for 3 months
Dermatology department, Zagazig University Hospitals, Faculty of Medicine, Zagazig University
Zagazig, Select Region, Egypt
RECRUITINGResponse to treatment
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 appearance, 3 = improved appearance, 4 = unaltered appearance, 5 = worsened appearance). The duration taken till complete clearance will be assessed as well.
Time frame: three months
Time to complete clearance
The duration taken till complete clearance will be assessed as well.
Time frame: 12 weeks
Quality of life index
The change in patients' quality of life using the difference between results of "Melasma Quality of Life Index" at baseline and end of treatment.
Time frame: 12 weeks
Treatment tolerability
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 patients' take/apply their medication.
Time frame: 12 weeks
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