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Sponsors and Collaborators: |
Massachusetts General Hospital Bayer |
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Information provided by: | Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00722761 |
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.
Condition | Intervention | Phase |
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Acne Vulgaris |
Drug: drospirenone and ethinyl estradiol Drug: Placebo tablets |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Single-Center, Randomized Double-Blind, Parallel-Group Study to Examine the Safety and Efficacy Of YAZ Compared With Placebo In The Treatment Of Moderate Truncal Acne Vulgaris |
Estimated Enrollment: | 100 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | July 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Active Comparator
Drospirenone and Ethinyl estradiol (YAZ)
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Drug: drospirenone and ethinyl estradiol
1 tablet daily
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B: Placebo Comparator
Placebo
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Drug: Placebo tablets
1 tablet daily
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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).
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA
EXCLUSION CRITERIA
Contact: Lynne M Hermosilla | 617-726-5066 | harvardskinstudies@partners.org |
United States, Massachusetts | |
Clinical Unit for Research Trials in Skin | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: Lynne Hermosilla 617-726-5066 harvardskinstudies@partners.org | |
Principal Investigator: Alexandra B Kimball, MD | |
Sub-Investigator: Maria B Alora-Palli, MD |
Principal Investigator: | Alexandra B. Kimball, MD, MPH | Massachusetts General Hospital |
Responsible Party: | Massachusetts General Hospital ( Alexandra B. Kimball, MD, MPH ) |
Study ID Numbers: | 2008-P-000754 |
Study First Received: | July 24, 2008 |
Last Updated: | August 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00722761 History of Changes |
Health Authority: | United States: Institutional Review Board |
YAZ oral contraceptive Acne vulgaris |
Estrogens Facial Dermatoses Skin Diseases Facies Contraceptive Agents Hormone Antagonists Estradiol valerate Contraceptives, Oral Hormones, Hormone Substitutes, and Hormone Antagonists Ethinyl Estradiol |
Sebaceous Gland Diseases Estradiol 17 beta-cypionate Hormones Acne Vulgaris Estradiol Exanthema Aldosterone Antagonists Estradiol 3-benzoate Drospirenone Polyestradiol phosphate |
Estrogens Facial Dermatoses Skin Diseases Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Ethinyl Estradiol Sebaceous Gland Diseases |
Hormones Acne Vulgaris Estradiol Pharmacologic Actions Aldosterone Antagonists Acneiform Eruptions Drospirenone |