Clinical trial NCT04100083: Spironolactone for Hidradenitis Suppurativa
Official title: Spironolactone in the Treatment of Hidradenitis Suppurativa: a Prospective, Open-Label Proof-of-Concept and Dose-Ranging Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Hidradenitis Suppurativa
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2019-09-24
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Proportion of patients with 2 grade improvement in Hidradenitis Suppurativa as assessed by physicians global assessment score
timeFrame: Baseline through one year
Secondary outcomes:
measure: Tolerability of spironolactone as measured by incidence of patient reported and physician observed treatment-related adverse events
timeFrame: Baseline through one year
measure: Proportion of patients achieving clinical response at month 3
timeFrame: Baseline through 3 months
measure: Proportion of patients achieving clinical response at any study visits during the optional treatment extension period of up to 1 year
timeFrame: Baseline through one year
measure: Change in patient-reported disease activity
timeFrame: Baseline through one year
measure: Comparison between group treatment effects
timeFrame: Baseline through one year
Other outcomes:
Locations:
Study officials:
affiliation: Medical University of South Carolina
name: Dirk Elston, MD
role: PRINCIPAL_INVESTIGATOR
References: