Spironolactone for the Treatment of Melasma

NCT03953209 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: 00076765
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Melasma

Keywords

spironolactone

Outcome Measures

Primary Outcomes (1)

• Proportion of patients achieving clinical response

  Clinical response defined as a 30% reduction in physician-assigned melanoma severity score on an anchored 100 mm visual analogue scale (VAS) with a minimum of 0 representing clear (better outcome) and a maximum of 100 representing very severe (worse outcome)

  baseline and 12 weeks

Secondary Outcomes (4)

• Proportion of patients achieving clinical response

  week 6, week 16, and optional treatment extension period visits lasting up to 1 yr

• Change in Dermatology Life Quality Index (DLQI)

  baseline, week 6, week 12, week 16, and week 6, week 16, and optional treatment extension period visits lasting up to 1 yr

• Tolerability of spironolactone as measured by incidence of treatment-related adverse events

  baseline, week 6, week 12, week 16, and week 6, week 16, and optional treatment extension period visits lasting up to 1 yr

• Comparing proportion of patients achieving clinical response between the three treatment arms: 50 mg, 100 mg, and 200 mg of spironolactone

  week 6, week 12, week 16, and week 6, week 16, and optional treatment extension period visits lasting up to 1 yr

Study Arms (3)

spironolactone 50 mg

EXPERIMENTAL

Oral administration of spironolactone 50 mg once daily for 12 weeks

Drug: Spironolactone 50Mg Tablet

spironolactone 100 mg

EXPERIMENTAL

Oral administration of spironolactone 100 mg once daily for 12 weeks

Drug: Spironolactone 100Mg Tablet

spironolactone 200 mg

EXPERIMENTAL

Oral administration of spironolactone 200 mg once daily for 12 weeks

Drug: Spironolactone 200Mg

Interventions

Spironolactone 50Mg Tablet DRUG

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

Also known as: Aldactone

spironolactone 50 mg

Spironolactone 100Mg Tablet DRUG

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

Also known as: Aldactone

spironolactone 100 mg

Spironolactone 200Mg DRUG

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

Also known as: Aldactone

spironolactone 200 mg

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: Males will be excluded from this study due to the high incidence of gynecomastia and sexual dysfunction seen in spironolactone use at higher doses in men. The drug is not routinely used to treat dermatologic conditions in men due to its poor tolerability.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Subject must be a female.
• Subject must be 18-70 years of age.
• 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.
• Subject must provide written informed consent prior to any study-related procedures being performed.
• Subject must be willing to comply with all clinical study procedures.

You may not qualify if:

• Subject is a pregnant or nursing female.
• Subject has previously received spironolactone or another antiandrogenic treatment for melasma.
• Subject is hyperkalemic, defined by a potassium level of greater than 5.1 mEq/liter.
• Subjects with Addison's disease.
• Subjects taking eplerenone or other potassium-sparing diuretics, lithium, cholestyramine, ACE inhibitors/angiotensin II antagonists/aldosterone blockers, or NSAIDS.
• Subjects receiving potassium supplementation.
• Subjects with history of renal disease or an eFGR \< 30.
• Subjects with acute or chronic liver failure.
• Subject has an acute psychiatric condition that impairs ability to give consent or follow study protocols.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of SC

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Melanosis

Interventions

Spironolactone; Tablets; Canrenoic Acid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Dosage Forms; Pharmaceutical Preparations; Pregnadienes

Study Officials

• Dirk Elston, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2019
• First Posted: May 16, 2019
• Study Start: March 5, 2020
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: September 4, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)