NCT03953209

Spironolactone for the Treatment of Melasma

Spironolactone for the Treatment of Melasma: a Prospective, Open-label Proof-of-concept and Dose-ranging Study

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to prospectively gather data on the efficacy and tolerability of spironolactone to treat refractory melasma and to compare treatment response of randomized 50 mg, 100mg, and 200mg per day dosing.

Detailed description

Melasma is a common, acquired condition of the skin characterized by symmetric reticulated hyperpigmented patches, most often of the central face and mandible. An array of treatment modalities encompassing topical, oral, procedural, and combination therapies have been used to treat the disorder, with varying levels of immediate and long-term efficacy. Current treatment options are often unsuccessful in inducing complete disease remission. The tolerability of certain treatments is a valid concern, with adverse reactions such as irritation, peeling, burning, and post-inflammatory hyperpigmentation a common occurrence. Antiandrogens like spironolactone have been successfully used as adjunctive treatment for melasma. However, evidence for its off-label use for this purpose remains anecdotal. Clinical data regarding its efficacy and dosing are absent from the literature and are likely barriers to the drug's use in melasma. The high relapse rates and unfavorable side effect profiles of traditional treatment regimens underlie the need for an improved multimodal approach. This prospective, randomized trial seeks to obtain information about the efficacy and tolerability of spironolactone to treat refractory melasma to guide future studies and clinical decision making. Participants will be randomized to one of the three dosage groups and take the study drug for 12 weeks. Outcomes will be assessed at baseline, week 6, week 12, and week 16. Subjects may opt to participate in a treatment extension period of up to 9 additional months, in which they will return to clinic monthly for outcome assessment.

Conditions

• Melasma

Interventions

Type	Name	Description
DRUG	Spironolactone 50Mg Tablet	Oral administration of one spironolactone 50 mg tablet once daily for 12 weeks
DRUG	Spironolactone 100Mg Tablet	Oral administration of one spironolactone 100 mg tablet once daily for 12 weeks
DRUG	Spironolactone 200Mg	Oral administration of two spironolactone 100 mg tablets once daily for 12 weeks

Timeline

• Start date: 2020-03-05
• Primary completion: 2021-01-01
• Completion: 2021-01-01
• First posted: 2019-05-16
• Last updated: 2024-09-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study