Sponsor study identifier
interventional
0
0 countries
N/A
Study Start
September 21, 2020
Actual (reported)Primary Completion
June 21, 2021
Actual (reported)Study Completion
June 21, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 21, 2021
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 20, 2019
Actual (reported)September 24, 2019
Actual (reported)September 21, 2020
Actual (reported)June 21, 2021
Actual (reported)June 21, 2021
Actual (reported)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
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
Patients taking 50mg Spironolactone
Patients taking 100mg Spironolactone
Patients taking 200mg Spironolactone
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.
Dirk Elston, MD
Medical University of South Carolina
0 participants (actual enrollment reported by the registry).
First Submitted
September 20, 2019
First Posted
September 24, 2019
Study Start
September 21, 2020
Actual (reported)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.
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.
Contact the study team to confirm eligibility.
Primary Completion
June 21, 2021
Actual (reported)Study Completion
June 21, 2021
Actual (reported)Last Updated
September 19, 2024
Record last verified: 2024-09
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Source: ClinicalTrials.gov.
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