Oral Isotretinoin in Melasma a Randomized Controlled Trial

Phase 1

Recruiting

• Conditions: Melasma
• Interventions: Drug: Triple combination formula; Drug: Isotretinoin

• 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 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"

Study Timeline

• Study Start: 2023-03-01
• Status Verified: 2023-12
• Study First Submitted: 2023-12-30
• Study First Submitted QC: 2023-12-30
• Last Update Submitted: 2023-12-30
• Study First Posted: 2024-01-11
• Last Update Posted: 2024-01-11
• Primary Completion: 2024-01-31
• Study Completion: 2024-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 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

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 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 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 patients' take/apply their medication.
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