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Spironolactone for Hidradenitis Suppurativa

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04100083
Recruitment Status : Not yet recruiting
First Posted : September 24, 2019
Last Update Posted : December 11, 2019
Sponsor:
Information provided by (Responsible Party):
Medical University of South Carolina

Tracking Information
First Submitted Date  ICMJE September 20, 2019
First Posted Date  ICMJE September 24, 2019
Last Update Posted Date December 11, 2019
Estimated Study Start Date  ICMJE January 21, 2020
Estimated Primary Completion Date June 21, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 20, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04100083 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 20, 2019)
  • Tolerability of spironolactone as measured by incidence of patient reported and physician observed treatment-related adverse events [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline through one year ]
    This will be defined as the estimate of difference in proportion of treatment responders between three treatment arms
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Spironolactone for Hidradenitis Suppurativa
Official Title  ICMJE Spironolactone in the Treatment of Hidradenitis Suppurativa: A Prospective, Open-Label Proof-of-Concept and Dose-Ranging Study
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hidradenitis Suppurativa
Intervention  ICMJE
  • 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.

  • Drug: 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.

  • Drug: 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.

Study Arms  ICMJE
  • Active Comparator: Group 1
    Patients taking 50mg Spironolactone
    Intervention: Drug: Spironolactone 50 MG
  • Active Comparator: Group 2
    Patients taking 100mg Spironolactone
    Intervention: Drug: Spironolactone 100mg
  • Active Comparator: Group 3
    Patients taking 200mg Spironolactone
    Intervention: Drug: Spironolactone 200 mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 20, 2019)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 21, 2020
Estimated Primary Completion Date June 21, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04100083
Other Study ID Numbers  ICMJE 00083948
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Medical University of South Carolina
Study Sponsor  ICMJE Medical University of South Carolina
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dirk Elston, MD Medical University of South Carolina
PRS Account Medical University of South Carolina
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP