Safety and Efficacy Of Drospirenone and Ethinyl Estradiol vs Placebo in the Treatment of Truncal Acne
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      Acne is a common skin disease that affects 85-100% of the population. Although it often
      appears during puberty, it may persist during the third decade of life and even later. It is
      characterized by a variety of lesions consisting of non-inflammatory lesions known as
      comedones, and inflammatory lesions such as papules, pustules, nodules and cysts. It commonly
      occurs on the face, chest, and back. Although not as noticeable as facial acne, truncal acne
      may also affect a person's self esteem and body image and reduce one's participation in
      sports because of the need to undress in a shared locker room. Most acne studies focus on
      facial acne and ignore treatment outcomes in the chest and back.

      The pathogenesis of acne is multifactorial, developing in the sebaceous gland. These factors
      include intrafollicular hypercornification, which induces follicular obstruction resulting in
      comedone formation, excess sebum production, Propionibacterium acnes activity and
      inflammation.

      Hormone therapies, such as oral contraceptives and antiandrogens (e.g. spironolactone)
      counteract the effects of androgens on the sebaceous glands. It has been over ten years since
      estrogen-containing oral contraceptives (OCs) first obtained FDA approval for use in acne.
      Since then, several randomized controlled trials have corroborated their efficacy and safety
      for this growing indication in women of child bearing age. Studies have shown hormonal
      therapies to be effective in treating moderate acne vulgaris in women with no known
      contraindication to OC therapy.

      YAZ is an oral contraceptive that is FDA approved for acne vulgaris. Unlike other progestins,
      drospirenone has unique antimineralocorticoid (mild diuretic effect) and antiandrogenic
      properties. The antiandrogenic property of drospirenone means that it blocks the male sex
      hormones that can cause acne. In two multicenter, double blind, randomized,
      placebo-controlled studies, 889 subjects, ages 14 to 45 years, with moderate acne received
      YAZ or placebo for six 28 day cycles. The primary efficacy endpoints were the percent change
      in inflammatory lesions, non-inflammatory lesions, total lesions, and the percentage of
      subjects with a "clear" or "almost clear" rating on the Investigator's Static Global
      Assessment (ISGA) scale on day 15 of cycle 6.

      Subjects will be assigned to a treatment group upon randomization. Bayer HealthCare
      Pharmaceuticals personnel, investigators, subjects and study nurse/coordinators will be
      blinded to the study product treatment assignment. The study duration will be 24 weeks with
      visits at screening, baseline (week 0), week 6, week 12, week 18, and week 24. Lesion counts
      (total, inflammatory, non-inflammatory) and an ISGA, and photography will be performed on
      every visit. A physical examination will be done at baseline and Week 24. Safety will be
      assessed from reported adverse events (AEs).
    

Intervention name(s): drospirenone and ethinyl estradiol; Placebo tablet
Intervention type(s): Drug; Drug
Intervention description(s): 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
Other intervention name(s): YAZ; Placebo
Intervention MeSH terms: Drospirenone; Ethinyl Estradiol; Drospirenone and ethinyl estradiol combination; Estradiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: YAZ; oral contraceptive; Acne vulgaris