Hidradenitis SuppurativaPhase 4NCT04100083
Spironolactone for Hidradenitis Suppurativa
A Phase 4 study testing Spironolactone 50 MG, Spironolactone 100mg and Spironolactone 200 mg in people with Hidradenitis Suppurativa, run by Medical University of South Carolina.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Hidradenitis Suppurativa
- What is being tested?
- Spironolactone 50 MG, Spironolactone 100mg and Spironolactone 200 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 21 Sep 2020to 21 Jun 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.)
- 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.
- 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.
- Subject must be a female.
- Subject must be 18-70 years of age.
- 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.
- Subject must provide written informed consent prior to any study-related procedures being performed.
- 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.)
- Subject has previously received spironolactone or another antiandrogenic treatment for hidradenitis suppurativa.
- The subject is a pregnant or nursing female.
- Subject is hyperkalemic, defined by a potassium level of greater than 5.1 mEq/liter.
- Subjects with Addison's disease.
- Subjects taking eplerenone or other potassium-sparing diuretics, lithium, cholestyramine, ACE inhibitors/angiotensin II antagonists/aldosterone blockers, or NSAIDS.
- Subjects receiving potassium supplementation.
- Subjects with history of renal disease or an eFGR < 30.
- Subjects with acute or chronic liver failure.
- 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
About this study
Official title: Spironolactone in the Treatment of Hidradenitis Suppurativa: a Prospective, Open-Label Proof-of-Concept and Dose-Ranging Study
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.
- Conditions
- Hidradenitis Suppurativa
- Being tested
- Spironolactone 50 MG, Spironolactone 100mg, Spironolactone 200 mg
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spironolactone 50 MGDrug
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 100mgDrug
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 mgDrug
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 group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Patients taking 50mg Spironolactone Receives: Drug: Spironolactone 50 MG |
| Group 2 | Active comparator | Patients taking 100mg Spironolactone Receives: Drug: Spironolactone 100mg |
| Group 3 | Active comparator | Patients taking 200mg Spironolactone Receives: Drug: Spironolactone 200 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline through one year
Secondary outcomes (5)
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
Measured: 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.
Measured: 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.
Measured: 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),
Measured: 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
Measured: Baseline through one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study start21 Sep 2020
- Primary completion21 Jun 2021
- Study completion21 Jun 2021
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dirk Elston, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04100083
- Sponsor's protocol ID
- 00083948
- Status last verified
- Sep 2024
- First submitted
- 20 Sep 2019
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spironolactone in the Treatment of Hidradenitis Suppurativa: a Prospective, Open-Label Proof-of-Concept and Dose-Ranging Study
- ClinicalTrials.gov ID
- NCT04100083
- Acronym / sponsor ID
- 00083948
- Conditions
- Hidradenitis Suppurativa
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 21 Sep 2020 (actual)
- Primary completion
- 21 Jun 2021 (actual)
- Study completion
- 21 Jun 2021 (actual)
- First posted
- 24 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: Spironolactone 50 MGPatients taking 50mg Spironolactone |
| Group 2 | Active comparator | Drug: Spironolactone 100mgPatients taking 100mg Spironolactone |
| Group 3 | Active comparator | Drug: Spironolactone 200 mgPatients taking 200mg Spironolactone |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spironolactone 50 MGStudy 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. | Drug | Group 1 |
| Spironolactone 100mgStudy 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. | Drug | Group 2 |
| Spironolactone 200 mgStudy 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. | Drug | Group 3 |
Primary outcome
Proportion of patients with 2 grade improvement in Hidradenitis Suppurativa as assessed by physicians global assessment score
Time frame: 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.
5 secondary outcomes
Tolerability of spironolactone as measured by incidence of patient reported and physician observed treatment-related adverse events
Time frame: Baseline through one year
Proportion of patients achieving clinical response at month 3
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
Time frame: Baseline through one year
Change in patient-reported disease activity
Time frame: Baseline through one year
Comparison between group treatment effects
Time frame: Baseline through one year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dirk Elston, MD principal investigator
Medical University of South Carolina
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Spironolactone 50 MG, Spironolactone 100mg and Spironolactone 200 mg in people with Hidradenitis Suppurativa, run by Medical University of South Carolina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with 2 grade improvement in Hidradenitis Suppurativa as assessed by physicians global assessment score (time frame: Baseline through one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.