Oral Isotretinoin in Melasma a Randomized Controlled Trial

Last updated: December 30, 2023
Sponsor: Zagazig University
Overall Status: Active - Recruiting

Phase

1

Condition

N/A

Treatment

Triple combination formula

Isotretinoin

Clinical Study ID

NCT06201624
ZU-IRB#10462/26-2-2023
  • Ages 18-50
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 contraceptivemethods during study period
  5. Patients with skin type I-V

Exclusion

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 couldinterfere with the outcome of the study

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Triple combination formula
Phase: 1
Study Start date:
March 01, 2023
Estimated Completion Date:
May 31, 2024

Study 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"

Connect with a study center

  • Dermatology department, Zagazig University Hospitals, Faculty of Medicine, Zagazig University

    Zagazig, Select Region 44511
    Egypt

    Active - Recruiting

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