Spironolactone for Hidradenitis Suppurativa

Hidradenitis Suppurativa Clinical Trial

Official title:

Spironolactone in the Treatment of Hidradenitis Suppurativa: A Prospective, Open-Label Proof-of-Concept and Dose-Ranging Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04100083
• Other study ID #: 00083948
• Status: Withdrawn
• Phase: Phase 4
• Start date: September 21, 2020
• Est. completion date: June 21, 2021

Study information

• Verified date: October 2020
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 21, 2021
• Est. primary completion date: June 21, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hidradenitis
• Hidradenitis Suppurativa

Intervention

Drug:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Tolerability of spironolactone as measured by incidence of patient reported and physician observed treatment-related adverse events	Adverse effects will define tolerability as Including, but not limited to hyperkalemia, renal insufficiency, menstrual irregularities (metrorrhagia, amenorrhea, breakthrough bleeding), breast tenderness and enlargement, orthostatic hypotension, and changes in libido] and subject self-assessment using the Dermatology Life Quality Index (DLQI) - a validated 10-item dermatology-specific quality of life instrument	Baseline through one year
Secondary	Proportion of patients achieving clinical response at month 3	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. Its stages are as follows: Clear-No inflammatory or noninflammatory nodules, Minimal-Only the presence of noninflammatory nodules, Mild-<5 inflammatory nodules without abscesses draining fistulas or 1 abscess or draining fistula without additional inflammatory nodules, Moderate-greater than or equal to 5 inflammatory nodules or 1 abscess or draining fistula and greater than or equal to 1 inflammatory nodule or 2-5 abscesses or draining fistulas and <10 inflammatory nodules, Severe-2-5 abscesses or draining fistulas and greater than or equal to 10 inflammatory nodules, Very Severe--5 abscesses or draining fistulas.	Baseline through 3 months
Secondary	Proportion of patients achieving clinical response at any study visits during the optional treatment extension period of up to 1 year	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. Its stages are as follows: Clear-No inflammatory or noninflammatory nodules, Minimal-Only the presence of noninflammatory nodules, Mild-<5 inflammatory nodules without abscesses draining fistulas or 1 abscess or draining fistula without additional inflammatory nodules, Moderate-greater than or equal to 5 inflammatory nodules or 1 abscess or draining fistula and greater than or equal to 1 inflammatory nodule or 2-5 abscesses or draining fistulas and <10 inflammatory nodules, Severe-2-5 abscesses or draining fistulas and greater than or equal to 10 inflammatory nodules, Very Severe--5 abscesses or draining fistulas.	Baseline through one year
Secondary	Change in patient-reported disease activity	Change will be define from baseline using a 100 mm VAS ranging from 0 mm (no disease activity) and 100 mm (worst disease activity possible),	Baseline through one year
Secondary	Comparison between group treatment effects	This will be defined as the estimate of difference in proportion of treatment responders between three treatment arms	Baseline through one year