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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
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 \[consent and enrollment followed by baseline exam (0 months), 3 months, 6 months, and follow up at 7 months, with optional treatment extension period for up to one year of total treatment during which patients will follow up every 3 months The drug will be taken via oral tablets once daily for a duration of 6 months. Patients will be instructed to continue any current treatment regimen for hidradenitis suppurativa that was initiated at least 4 weeks prior to their enrollment in the study. Patients will be instructed to avoid potassium supplements and foods containing high levels of potassium, including salt substitutes, which could potentially lead to hyperkalemia. They will be instructed to avoid medications listed in the exclusion criteria.
Proportion of patients with 2 grade improvement in Hidradenitis Suppurativa as assessed by physicians global assessment score
The proportion of patients achieving a clinical response - defined as at least a 2-grade improvement in Hidradenitis Suppurativa Physician's Global Assessment (HS-PGA) score relative to baseline at 6 months. HS-PGA is an anchored 6-stage HS-specific physician global assessment scale that was defined for use in a phase-II clinical trial. It is based on the number and type of nodules, abscesses, and fistulas.
Time frame: Baseline through one year
Tolerability of spironolactone as measured by incidence of patient reported and physician observed treatment-related adverse events
Adverse effects will define tolerability as Including, but not limited to hyperkalemia, renal insufficiency, menstrual irregularities (metrorrhagia, amenorrhea, breakthrough bleeding), breast tenderness and enlargement, orthostatic hypotension, and changes in libido\] and subject self-assessment using the Dermatology Life Quality Index (DLQI) - a validated 10-item dermatology-specific quality of life instrument
Time frame: Baseline through one year
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.
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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.
Time frame: 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
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.
Time frame: Baseline through one year
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),
Time frame: Baseline through one year
Comparison between group treatment effects
This will be defined as the estimate of difference in proportion of treatment responders between three treatment arms
Time frame: Baseline through one year