NCT06201624

Oral Isotretinoin in Melasma a Randomized Controlled Trial

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Zagazig University · Other Government
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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"

Conditions

• Melasma

Interventions

Type	Name	Description
DRUG	Isotretinoin	Patients will receive 1mg/kg/day for 3 months
DRUG	Triple combination formula	Patients are instructed to apply the triple combination formula at night daily for 3 months

Timeline

• Start date: 2023-03-01
• Primary completion: 2024-01-31
• Completion: 2024-05-31
• First posted: 2024-01-11
• Last updated: 2024-01-11

Locations

1 site across 1 country: Egypt