A Study to Examine the Safety and Efficacy of Drospirenone and Ethinyl Estradiol (YAZ) Versus Placebo In HS
Condition: Hidradenitis Suppurativa
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Intervention: drospirenone and ethinyl estradiol (YAZ); Placebo
Intervention description: 1 tablet daily for 24 weeks; 1 tablet daily for 24 weeks
Intervention MeSH terms: Drospirenone; Ethinyl Estradiol; Drospirenone and ethinyl estradiol combination; Estradiol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 4.0
Sex: Female
Minimum age: 14 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: YAZ; oral contraceptive; hidradenitis suppurativa

Summary:

      The purpose of this study is to find out if taking a birth control pill, YAZ, is safe and
      effective for treating hidradenitis suppurativa. Hidradenitis suppurativa (HS) is a chronic
      (long lasting) skin disorder that mostly affects the armpits and groin area. It appears as
      blackheads and one or more red, tender bumps that may enlarge, break open, and drain pus.
      Scarring may result after several attacks of the disease.

      The exact cause of HS isn't known. However, it is believed that the plugging of hair
      follicles and bacterial infection that occur in acne also occur in HS. Many of the
      medications used for treating acne are also used for HS. However, none of the medications are
      consistently effective.

      YAZ is a combination birth control pill. Nearly all birth control pills are made up of a
      combination of estrogen and progestin hormones. YAZ contains ethinyl estradiol (an estrogen)
      and drospirenone (a progestin). People who develop acne have sebaceous glands that are
      over-stimulated by male sex hormones (androgens). Sebaceous glands secrete an oily substance
      into a hair follicle to lubricate hair or skin. The progestin in YAZ actually blocks the male
      sex hormones (androgens) that cause acne. Hormones seem to play a role in HS as the condition
      occurs after puberty. It affects more women than men and HS often gets worse around the time
      a women has her menstrual period.

      YAZ has been approved by the U.S. Food and Drug Administration (FDA) to treat moderate acne
      in women who desire an oral contraceptive for birth control.

      This study uses a placebo. A placebo looks like the study drug but contains no active drug.
      We use placebos in research studies to learn if the effects seen in research subjects are
      truly from the study drug or from other reasons.
    

Eligibility criteria:

        INCLUSION CRITERIA

          1. Female Subjects 14-45 years of age who have achieved spontaneous menarche.

          2. Clinical diagnosis of hidradenitis suppurativa of stage II or greater on the Hurley
             scale.

          3. Willing and able to understand and sign informed consent.

          4. Able to complete study and comply with study procedures.

        EXCLUSION CRITERIA

          1. Change is use of oral or topical antibiotics in past 90 days.

          2. Use of intralesional steroids within 30 days.

          3. Use of isotretinoin in past six months.

          4. Use of biologics such as Infliximab (Remicade®) or Etanercept (Enbrel®) within the
             past 3 months or 5 half lives (whichever is shorter).

          5. History of renal insufficiency

          6. History of hepatic dysfunction

          7. History of adrenal Insufficiency

          8. History of vascular or metabolic disease including existing or previous arterial
             thromboembolic diseases (myocardial infarction, stroke), existing or previous venous
             thromboembolic diseases (deep vein thrombosis, pulmonary embolism), and any condition
             which could increase the risk to suffer any of the above mentioned disorders

          9. History of hypertension

         10. History of Diabetes mellitus with vascular involvement

         11. Migraine headaches with focal neurological symptoms

         12. Major surgery with prolonged immobilization

         13. Known or suspected carcinoma of the breast

         14. History of Carcinoma of the endometrium or other known or suspected estrogen-dependent
             neoplasia

         15. Undiagnosed abnormal genital bleeding

         16. Cholestatic jaundice of pregnancy or jaundice with prior pill use

         17. History of Liver tumor (benign or malignant) or active liver disease

         18. Smokers

         19. Regular intake of medications that may increase potassium levels such as NSAIDS,
             potassium sparing diuretics, potassium supplementation, ACE inhibitors, Angiotensin-II
             receptor antagonists, heparin and aldosterone antagonists.

         20. Hypersensitivity to any component of the study drug

         21. Clinically significant abnormal findings or conditions (other than acne), which might,
             in the opinion of the Principal Investigator, interfere with study evaluations or pose
             a risk to subject safety during the study.

         22. Subjects who are known to be pregnant or planning a pregnancy.