Oral Isotretinoin in Melasma a Randomized Controlled Trial

Melasma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06201624
• Other study ID #: ZU-IRB#10462/26-2-2023
• Status: Recruiting
• Phase: Phase 1
• Start date: March 1, 2023
• Est. completion date: May 31, 2024

Study information

• Verified date: December 2023
• Source: Zagazig University
• Contact: Hagar Nofal, Dr.
• Phone: +201006387707
• Email: hagarnofal[@]aucegypt.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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"

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Melanosis
• Melasma

Intervention

Drug:
• Isotretinoin
Patients will receive 1mg/kg/day for 3 months
• Triple combination formula
Patients are instructed to apply the triple combination formula at night daily for 3 months

Locations

Country	Name	City	State
Egypt	Dermatology department, Zagazig University Hospitals, Faculty of Medicine, Zagazig University	Zagazig	Select Region

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Time to complete clearance	The duration taken till complete clearance will be assessed as well.	12 weeks
Secondary	Quality of life index	The change in patients' quality of life using the difference between results of "Melasma Quality of Life Index" at baseline and end of treatment.	12 weeks
Secondary	Treatment tolerability	Treatment tolerability will be assessed in terms of the side effects reported by the investigator or the patients in follow-up visits including but not limited to; facial erythema, scaling, a burning sensation, and cheilitis. Patients' compliance assessed by the percentage of patients withdraw from each arm of the study and the number of days per week the patients' take/apply their medication.	12 weeks