Spironolactone for Hidradenitis Suppurativa

• Status: Withdrawn
• Trial end date: 2021-06-21
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to evaluate if the drug spironolactone - which is used to treat acne and male pattern hair growth in women - is effective in treating hidradenitis suppurativa in females and which dose of the drug works the best. Participation in this study will take about 4 clinic visits over approximately 7 months with the option to continue for longer if desired.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Individuals will be screened for eligibility by a screening visit conducted by named investigators.

Inclusion Criteria To be eligible for the study: (All answers must be "YES" for subject to be eligible.)

1. Subject must have clinically diagnosed hidradenitis suppurativa, with an inadequate response to other treatment modalities, including but not limited to local or systemic antibiotics, immunosuppressive agents, retinoids, biologic therapies, surgical management.

2. Subject disease severity must be classified as 'mild' or more severe on the HS-PGA Scale at screening exam, because subjects classified as 'clear' or 'minimal' on the scale will be unable to achieve the prespecified treatment response.

3. Subject must be a female.

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

5. 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.

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

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

Exclusion Criteria The presence of the following excludes subjects from the study: (All answers must be "NO" for subject to be eligible.)

1. Subject has previously received spironolactone or another antiandrogenic treatment for hidradenitis suppurativa.

2. The subject is a pregnant or nursing female.

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.

• All races and ethnicities will be considered for inclusion in the study.

• 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. It is not routinely used to treat dermatologic conditions in men due to its poor tolerability.

• Subjects under the age of 18 will not be considered for inclusion in this study. The disease most often manifests during the second and third decades of life, therefore the disorder is far less prevalent in children and adolescents.2