Safety and Efficacy Of Drospirenone and Ethinyl Estradiol vs Placebo in the Treatment of Truncal Acne
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: drospirenone and ethinyl estradiol; Placebo tablet
Intervention description: Drosperinone (3mg) and ethinyl estradiol (0.02mg) tablet given once daily for 24 weeks; Placebo tablet (no active drug) given once daily for 24 weeks
Intervention MeSH terms: Drospirenone; Ethinyl Estradiol; Drospirenone and ethinyl estradiol combination; Estradiol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 30.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: YAZ; oral contraceptive; Acne vulgaris

Summary:

      The purpose of this study is to find out if taking a birth control pill, YAZ, is safe and
      effective for treating acne on the trunk (the main part of the body that does not include the
      arms, legs, and head).

      Acne vulgaris is a very common skin disorder. It is caused when oil-producing skin glands
      (sebaceous glands) become plugged. The plug can cause blackheads, whiteheads, pimples, and
      cysts on the face, neck, upper chest, and upper back.

      YAZ is a combination birth control pill. A "combination" pill means that it is made up of
      more than one major ingredient. Nearly all birth control pills are made up of a combination
      of estrogen and progestin hormones. Estrogens are steroid hormones produced by the ovaries
      responsible for the typical female features. Progestins are steroid hormones produced by the
      ovary and placenta responsible for making the uterus fit for pregnancy. YAZ also contains an
      estrogen called ethinyl estradiol, and a progestin called drospirenone. People who develop
      acne have sebaceous glands that are over-stimulated (that is, the sebaceous glands have
      increased activity) by male sex hormones (androgens). The progestin in YAZ blocks the male
      sex hormones (androgens) that cause acne.

      The study drug being used in this study is called YAZ. It has been approved by the U.S. Food
      and Drug Administration (FDA) to treat moderate acne in women who want an oral contraceptive
      for birth control.

      In this study, YAZ will be compared to a placebo for safety and effectiveness. A placebo
      looks like the study drug but contains no active drug (like a sugar pill). 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:

          -  Female Subjects 18-45 years of age who have achieved spontaneous menarche.

          -  A clinical diagnosis of truncal acne vulgaris and the desire for an oral contraceptive
             for birth control.

          -  A minimum of 10 but not more than 50 inflammatory lesions on the back and chest
             combined.

          -  Maximum of 5 nodules.

          -  Willing and able to understand and sign informed consent.

          -  Able to complete study and comply with study procedures.

        Exclusion Criteria:

          -  Use of topical acne medications such as tretinoin, benzoyl peroxide or topical
             antibiotics within 2 weeks

          -  Use of oral antibiotics within 30 days.

          -  Use of systemic corticosteroids within 4 weeks.

          -  Use of oral contraceptives within 12 weeks.

          -  Use of isotretinoin in past six months.

          -  Use of phototherapy devices for acne such as ClearLight or Zenozapper within 1 week.

          -  Use of tanning booths or lamps within 1 week prior to baseline.

          -  BMI >30

          -  History of renal insufficiency

          -  History of hepatic dysfunction

          -  History of adrenal Insufficiency

          -  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

          -  History of hypertension

          -  Diabetes mellitus with vascular involvement

          -  Migraine headaches with focal neurological symptoms

          -  Recent major surgery with prolonged immobilization

          -  Known or suspected carcinoma of the breast

          -  Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia

          -  Undiagnosed abnormal genital bleeding

          -  Cholestatic jaundice of pregnancy or jaundice with prior pill use

          -  Liver tumor (benign or malignant) or active liver disease

          -  Smoking > ½ pack of cigarettes/week

          -  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.

          -  Hypersensitivity to any component of the study drug

          -  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.

          -  Subjects who are known to be pregnant or planning a pregnancy.