Spironolactone for Hidradenitis Suppurativa

NCT ID: NCT04100083

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-21
• Study Completion Date: 2021-06-21

Brief 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.

Conditions

Hidradenitis Suppurativa

Study Design

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

Study Groups

Group 1

Patients taking 50mg Spironolactone

Group Type: ACTIVE_COMPARATOR

Spironolactone 50 MG

Intervention Type: DRUG

Study visit timeline: initial visit [consent and enrollment followed by baseline exam (0 months), 3 months, 6 months, and follow up at 7 months, with optional treatment extension period for up to one year of total treatment during which patients will follow up every 3 months

The drug will be taken via oral tablets once daily for a duration of 6 months. Patients will be instructed to continue any current treatment regimen for hidradenitis suppurativa that was initiated at least 4 weeks prior to their enrollment in the study. Patients will be instructed to avoid potassium supplements and foods containing high levels of potassium, including salt substitutes, which could potentially lead to hyperkalemia. They will be instructed to avoid medications listed in the exclusion criteria.

Group 2

Patients taking 100mg Spironolactone

Group Type: ACTIVE_COMPARATOR

Spironolactone 100mg

Intervention Type: DRUG

Study visit timeline: initial visit [consent and enrollment followed by baseline exam (0 months), 3 months, 6 months, and follow up at 7 months, with optional treatment extension period for up to one year of total treatment during which patients will follow up every 3 months

The drug will be taken via oral tablets once daily for a duration of 6 months. Patients will be instructed to continue any current treatment regimen for hidradenitis suppurativa that was initiated at least 4 weeks prior to their enrollment in the study. Patients will be instructed to avoid potassium supplements and foods containing high levels of potassium, including salt substitutes, which could potentially lead to hyperkalemia. They will be instructed to avoid medications listed in the exclusion criteria.

Group 3

Patients taking 200mg Spironolactone

Group Type: ACTIVE_COMPARATOR

Spironolactone 200 mg

Intervention Type: DRUG

Study visit timeline: initial visit [consent and enrollment followed by baseline exam (0 months), 3 months, 6 months, and follow up at 7 months, with optional treatment extension period for up to one year of total treatment during which patients will follow up every 3 months

The drug will be taken via oral tablets once daily for a duration of 6 months. Patients will be instructed to continue any current treatment regimen for hidradenitis suppurativa that was initiated at least 4 weeks prior to their enrollment in the study. Patients will be instructed to avoid potassium supplements and foods containing high levels of potassium, including salt substitutes, which could potentially lead to hyperkalemia. They will be instructed to avoid medications listed in the exclusion criteria.

Interventions

Spironolactone 50 MG

Study visit timeline: initial visit [consent and enrollment followed by baseline exam (0 months), 3 months, 6 months, and follow up at 7 months, with optional treatment extension period for up to one year of total treatment during which patients will follow up every 3 months

The drug will be taken via oral tablets once daily for a duration of 6 months. Patients will be instructed to continue any current treatment regimen for hidradenitis suppurativa that was initiated at least 4 weeks prior to their enrollment in the study. Patients will be instructed to avoid potassium supplements and foods containing high levels of potassium, including salt substitutes, which could potentially lead to hyperkalemia. They will be instructed to avoid medications listed in the exclusion criteria.

Intervention Type: DRUG

Spironolactone 100mg

Study visit timeline: initial visit [consent and enrollment followed by baseline exam (0 months), 3 months, 6 months, and follow up at 7 months, with optional treatment extension period for up to one year of total treatment during which patients will follow up every 3 months

The drug will be taken via oral tablets once daily for a duration of 6 months. Patients will be instructed to continue any current treatment regimen for hidradenitis suppurativa that was initiated at least 4 weeks prior to their enrollment in the study. Patients will be instructed to avoid potassium supplements and foods containing high levels of potassium, including salt substitutes, which could potentially lead to hyperkalemia. They will be instructed to avoid medications listed in the exclusion criteria.

Intervention Type: DRUG

Spironolactone 200 mg

Study visit timeline: initial visit [consent and enrollment followed by baseline exam (0 months), 3 months, 6 months, and follow up at 7 months, with optional treatment extension period for up to one year of total treatment during which patients will follow up every 3 months

The drug will be taken via oral tablets once daily for a duration of 6 months. Patients will be instructed to continue any current treatment regimen for hidradenitis suppurativa that was initiated at least 4 weeks prior to their enrollment in the study. Patients will be instructed to avoid potassium supplements and foods containing high levels of potassium, including salt substitutes, which could potentially lead to hyperkalemia. They will be instructed to avoid medications listed in the exclusion criteria.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

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

• 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

Other Identifiers

00083948

Identifier Type: -

Identifier Source: org_study_id