Oral Isotretinoin in Melasma a Randomized Controlled Trial

NCT ID: NCT06201624

Last Updated: 2024-01-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2024-05-31

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"

Conditions

Melasma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Isotretinoin

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

Group Type: EXPERIMENTAL

Isotretinoin

Intervention Type: DRUG

Patients will receive 1mg/kg/day for 3 months

Kligman Formula arm

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

Group Type: ACTIVE_COMPARATOR

Triple combination formula

Intervention Type: DRUG

Patients are instructed to apply the triple combination formula at night daily for 3 months

Interventions

Isotretinoin

Patients will receive 1mg/kg/day for 3 months

Intervention Type: DRUG

Triple combination formula

Patients are instructed to apply the triple combination formula at night daily for 3 months

Intervention Type: DRUG

Other Intervention Names

modified Kligman formula

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Hagar Nofal

Lecturer of Dermatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Zagazig, Select Region, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Hagar Nofal, Dr.

Role: CONTACT

hagarnofal@aucegypt.edu

+201006387707

Facility Contacts

Hagar Nofal, Dr.

Role: primary

hagarnofal@aucegypt.edu

01006387707

References

Artzi O, Horovitz T, Bar-Ilan E, Shehadeh W, Koren A, Zusmanovitch L, Mehrabi JN, Salameh F, Isman Nelkenbaum G, Zur E, Sprecher E, Mashiah J. The pathogenesis of melasma and implications for treatment. J Cosmet Dermatol. 2021 Nov;20(11):3432-3445. doi: 10.1111/jocd.14382. Epub 2021 Aug 19.

Reference Type: BACKGROUND

PMID: 34411403 (View on PubMed)

Garner ML, McShane DB, Burkhart CN, Morrell DS. Isotretinoin and vitiligo: can chronic cheilitis cause koebnerization? Pediatr Dermatol. 2015 May-Jun;32(3):e108-9. doi: 10.1111/pde.12538. Epub 2015 Mar 17.

Reference Type: BACKGROUND

PMID: 25781892 (View on PubMed)

Muthu SK, Narang T, Saikia UN, Kanwar AJ, Parsad D, Dogra S. Low-dose oral isotretinoin therapy in lichen planus pigmentosus: an open-label non-randomized prospective pilot study. Int J Dermatol. 2016 Sep;55(9):1048-54. doi: 10.1111/ijd.13293. Epub 2016 Apr 7.

Reference Type: BACKGROUND

PMID: 27062273 (View on PubMed)

Other Identifiers

ZU-IRB#10462/26-2-2023

Identifier Type: -

Identifier Source: org_study_id