Melasma
Conditions
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 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.
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. 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
Interventions
DRUGIsotretinoin
Patients will receive 1mg/kg/day for 3 months
Patients are instructed to apply the triple combination formula at night daily for 3 months
Sponsors
Zagazig University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 appearance, 3 = improved appearance, 4 = unaltered appearance, 5 = worsened appearance). The duration taken till complete clearance will be assessed as well. |
| Time to complete clearance | 12 weeks | The duration taken till complete clearance will be assessed as well. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 patients' take/apply their medication. |
Countries
Egypt
Contacts
Primary ContactHagar Nofal, Dr.
Outcome results
None listed