Spironolactone for Hidradenitis Suppurativa

Phase 4

Withdrawn

• Conditions: Hidradenitis Suppurativa
• Interventions: Drug: Spironolactone 50 MG; Drug: Spironolactone 100mg; Drug: Spironolactone 200 mg

• Registration Number: NCT04100083
• Lead Sponsor: Medical University of South Carolina

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-20
• Study First Submitted QC: 2019-09-20
• Study First Posted: 2019-09-24
• Study Start: 2020-09-21
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-22
• Last Update Posted: 2020-10-26
• Primary Completion: 2021-06-21
• Study Completion: 2021-06-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Spironolactone 50 MG	Patients taking 50mg Spironolactone
Group 2	Spironolactone 100mg	Patients taking 100mg Spironolactone
Group 3	Spironolactone 200 mg	Patients taking 200mg Spironolactone

Primary Outcome Measures

Name	Time	Method
Proportion of patients with 2 grade improvement in Hidradenitis Suppurativa as assessed by physicians global assessment score	Baseline through one year	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.

Secondary Outcome Measures

Name	Time	Method
Tolerability of spironolactone as measured by incidence of patient reported and physician observed treatment-related adverse events	Baseline through one year	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
Proportion of patients achieving clinical response at month 3	Baseline through 3 months	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.
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	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.
Change in patient-reported disease activity	Baseline through one year	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),
Comparison between group treatment effects	Baseline through one year	This will be defined as the estimate of difference in proportion of treatment responders between three treatment arms