Oral Isotretinoin in Melasma a Randomized Controlled Trial

Zagazig University

Status and phase: Enrolling; Phase 1

Conditions: Melasma

Treatments: Drug: Triple combination formula; Drug: Isotretinoin

Study type: Interventional

Funder types: Other

Identifiers

NCT06201624

ZU-IRB#10462/26-2-2023

Details and patient eligibility

About

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.

Full 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"

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

Isotretinoin

Experimental group

Description:

patients will receive oral isotretinoin (1 mg/kg/day) for 3 months

Treatment:

Drug: Isotretinoin

Kligman Formula arm

Active Comparator group

Description:

patients will receive topical triple combination formula at night everyday over the affected areas for 3 months

Treatment:

Drug: Triple combination formula