Safety and Efficacy Of Drospirenone and Ethinyl Estradiol vs Placebo in the Treatment of Truncal Acne

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.

Timeline

Start

2009-04

Primary completion

2012-04

Completion

2012-04

Drugs

Indications