Spironolactone for the Treatment of Melasma

• Status: Withdrawn
• Trial end date: 2021-01-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of South Carolina
• Treatments: Spironolactone

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.