Spironolactone for the Treatment of Melasma

NCT ID: NCT03953209

Last Updated: 2024-09-04

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-05
• Study Completion Date: 2021-01-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

spironolactone 50 mg

Oral administration of spironolactone 50 mg once daily for 12 weeks

Group Type: EXPERIMENTAL

Spironolactone 50Mg Tablet

Intervention Type: DRUG

Oral administration of one spironolactone 50 mg tablet once daily for 12 weeks

spironolactone 100 mg

Oral administration of spironolactone 100 mg once daily for 12 weeks

Group Type: EXPERIMENTAL

Spironolactone 100Mg Tablet

Intervention Type: DRUG

Oral administration of one spironolactone 100 mg tablet once daily for 12 weeks

spironolactone 200 mg

Oral administration of spironolactone 200 mg once daily for 12 weeks

Group Type: EXPERIMENTAL

Spironolactone 200Mg

Intervention Type: DRUG

Oral administration of two spironolactone 100 mg tablets once daily for 12 weeks

Interventions

Spironolactone 50Mg Tablet

Oral administration of one spironolactone 50 mg tablet once daily for 12 weeks

Intervention Type: DRUG

Spironolactone 100Mg Tablet

Oral administration of one spironolactone 100 mg tablet once daily for 12 weeks

Intervention Type: DRUG

Spironolactone 200Mg

Oral administration of two spironolactone 100 mg tablets once daily for 12 weeks

Intervention Type: DRUG

Other Intervention Names

Aldactone; Aldactone; Aldactone

Eligibility Criteria

Inclusion Criteria

1. Subject must have clinically diagnosed melasma, with an inadequate response to other treatment modalities, including but not limited to depigmenting agents, topical retinoids, topical steroids, peeling agents, laser and light therapies and combined topical creams.

2. Subject must be a female.

3. Subject must be 18-70 years of age.

4. Women of child-bearing potential must be on effective contraception. Acceptable methods of contraception include oral contraceptive pills (OCPs), hormonal or copper IUDs, contraceptive implants, contraceptive injections, birth control patches, vaginal rings, condom, sponge, diaphragm with spermicide, or prior surgical sterilization.

5. Subject must provide written informed consent prior to any study-related procedures being performed.

6. Subject must be willing to comply with all clinical study procedures.

Exclusion Criteria

1. Subject is a pregnant or nursing female.

2. Subject has previously received spironolactone or another antiandrogenic treatment for melasma.

3. Subject is hyperkalemic, defined by a potassium level of greater than 5.1 mEq/liter.

4. Subjects with Addison's disease.

5. Subjects taking eplerenone or other potassium-sparing diuretics, lithium, cholestyramine, ACE inhibitors/angiotensin II antagonists/aldosterone blockers, or NSAIDS.

6. Subjects receiving potassium supplementation.

7. Subjects with history of renal disease or an eFGR < 30.

8. Subjects with acute or chronic liver failure.

9. Subject has an acute psychiatric condition that impairs ability to give consent or follow study protocols.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dirk Elston, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Medical University of SC

Charleston, South Carolina, United States

Countries

United States

Other Identifiers

00076765

Identifier Type: -

Identifier Source: org_study_id