Oral Isotretinoin in Melasma a Randomized Controlled Trial

NCT06201624 | Unknown Phase 1

• 1 other identifier: ZU-IRB#10462/26-2-2023
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Melasma

Outcome Measures

Primary Outcomes (2)

• Response to treatment

  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.

  three months

• Time to complete clearance

  The duration taken till complete clearance will be assessed as well.

  12 weeks

Secondary Outcomes (2)

• Quality of life index

  12 weeks

• Treatment tolerability

  12 weeks

Study Arms (2)

Isotretinoin

EXPERIMENTAL

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

Drug: Isotretinoin

Kligman Formula arm

ACTIVE COMPARATOR

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

Drug: Triple combination formula

Interventions

Isotretinoin DRUG

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

Isotretinoin

Triple combination formula DRUG

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

Also known as: modified Kligman formula

Kligman Formula arm

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18 and 50 years
• Patients complaining of melasma.
• Patients with all types of melasma (epidermal, dermal and mixed)
• Sexually active women who is willing to follow at least 2 types of contraceptive methods during study period
• Patients with skin type I-V

You may not qualify if:

• Pregnant or nursing women.
• Women on any concurrent therapy for melasma.
• Patients that are using any therapy for melasma for the last 45 days.
• Patient with abnormal liver function test or lipid profile.
• Patients with allergy or hypersensitivity to the assigned drugs.
• Women not willing to follow contraceptive methods at time of study.
• Patients on facial treatments or photosensitizing drugs within previous 6 months.
• Patients with back or joint pain.
• Patients with pre-existing or dormant dermatologic disease on the face that could interfere with the outcome of the study

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

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

Zagazig, Select Region, 44511, Egypt

RECRUITING

Related Publications (3)

• 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.

  PMID: 34411403 BACKGROUND

• 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.

  PMID: 25781892 BACKGROUND

• 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.

  PMID: 27062273 BACKGROUND

MeSH Terms

Conditions

Melanosis

Interventions

Isotretinoin

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors

Central Study Contacts

Hagar Nofal, Dr.

CONTACT

+201006387707; hagarnofal@aucegypt.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Dermatology

Study Record Dates

• First Submitted: December 30, 2023
• First Posted: January 11, 2024
• Study Start: March 1, 2023
• Primary Completion: January 31, 2024
• Study Completion: May 31, 2024
• Last Updated: January 11, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

EG (1)