Using oral isotretinoin to treat melasma
Oral Isotretinoin in The Treatment of Melasma A Randomized Controlled Clinical Trial
This study is testing if taking oral isotretinoin can help people with melasma improve their skin compared to the usual cream treatment.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | Zagazig University Government |
| Locations | 1 site (Zagazig, Select Region) |
| Trial ID | NCT06201624 on ClinicalTrials.gov |
What this trial studies
This study investigates the efficacy and tolerability of oral isotretinoin as a treatment for melasma, a chronic skin condition that significantly affects quality of life. Participants will be compared against the current gold standard treatment, a topical triple combination formula. The study aims to include patients aged 18 to 50 with various types of melasma, while excluding those with certain health conditions or concurrent therapies. The research is conducted at Zagazig University Hospitals, focusing on a population that may have a higher prevalence of melasma.
Who should consider this trial
Good fit: Ideal candidates are sexually active women aged 18 to 50 with all types of melasma who can adhere to contraceptive methods.
Not a fit: Patients who are pregnant, nursing, or currently undergoing other treatments for melasma may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients suffering from melasma.
How similar studies have performed: This approach is novel as oral isotretinoin has not been previously investigated for treating melasma.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Zagazig, Select Region
- Dermatology department, Zagazig University Hospitals, Faculty of Medicine, Zagazig University — Zagazig, Select Region, Egypt (Recruiting)
Study contacts
- Study coordinator: Hagar Nofal, Dr.
- Email: hagarnofal@aucegypt.edu
- Phone: +201006387707
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.