Spironolactone for Hidradenitis Suppurativa

NCT04100083 | Withdrawn Phase 4

• 1 other identifier: 00083948
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with 2 grade improvement in Hidradenitis Suppurativa as assessed by physicians global assessment score

  The proportion of patients achieving a clinical response - defined as at least a 2-grade improvement in Hidradenitis Suppurativa Physician's Global Assessment (HS-PGA) score relative to baseline at 6 months. HS-PGA is an anchored 6-stage HS-specific physician global assessment scale that was defined for use in a phase-II clinical trial. It is based on the number and type of nodules, abscesses, and fistulas.

  Baseline through one year

Secondary Outcomes (5)

• Tolerability of spironolactone as measured by incidence of patient reported and physician observed treatment-related adverse events

  Baseline through one year

• Proportion of patients achieving clinical response at month 3

  Baseline through 3 months

• Proportion of patients achieving clinical response at any study visits during the optional treatment extension period of up to 1 year

  Baseline through one year

• Change in patient-reported disease activity

  Baseline through one year

• Comparison between group treatment effects

  Baseline through one year

Study Arms (3)

Group 1

ACTIVE COMPARATOR

Patients taking 50mg Spironolactone

Drug: Spironolactone 50 MG

Group 2

ACTIVE COMPARATOR

Patients taking 100mg Spironolactone

Drug: Spironolactone 100mg

Group 3

ACTIVE COMPARATOR

Patients taking 200mg Spironolactone

Drug: Spironolactone 200 mg

Interventions

Spironolactone 50 MG 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 1

Spironolactone 100mg 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

Spironolactone 200 mg 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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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 has previously received spironolactone or another antiandrogenic treatment for hidradenitis suppurativa.
• The subject is a pregnant or nursing female.
• 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.
• 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.

Sponsors & Collaborators

• Medical University of South Carolina: lead

MeSH Terms

Conditions

Hidradenitis Suppurativa

Interventions

Spironolactone; Canrenoic Acid

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnadienes

Study Officials

• Dirk Elston, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2019
• First Posted: September 24, 2019
• Study Start: September 21, 2020
• Primary Completion: June 21, 2021
• Study Completion: June 21, 2021
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share