Low-Dose OCs File With FDA for Acne Indication.

CHICAGO -- Physicians can add another oral contraceptive to their armamentarium for clearing moderate facial acne in women, Dr. Richard Derman said at the annual meeting of the American College of Obstetricians and Gynecologists.

Estrostep, a low-dose contraceptive consisting of 1 mg of norethindrone acetate and 20, 30, and 35 [micro]g of ethinyl estradiol, reduced the number of acne lesions by 48% in 297 women taking the agent, compared with a 36% reduction among 296 women on placebo, a significant difference. These findings emerged from a pooled analysis of data from two identical, randomized, placebo-controlled trials, said Dr. Derman, director of ambulatory services in ob.gyn. at the University of Illinois at Chicago.

Pfizer Inc., the manufacturer of Estrostep, has requested approval of a new indication for the OC for use in the treatment of moderate acne vulgaris.

So far, Ortho-McNeil's Ortho Tri-Cyclen (norgestimate/ethinyl estradiol) is the only oral contraceptive to have received Food and Drug Administration approval for the indication of acne clearing. Wyeth-Ayerst Laboratories has also applied to market its low-dose oral contraceptive Alesse (1evonorgestrel/ethinyl estradiol) for the acne indication. In all cases, the prescribed indication is limited to women of reproductive age who desire contraception, have no contraindications to OCs, and are unresponsive to topical acne medications.

"Most of us believe clinically that oral contraceptives to a greater or lesser degree help our acne patients," Dr. Derman said.

New York-based dermatologist Diane Berson said that she has been prescribing. OCs off label for the clearance of moderate acne vulgaris for years. OCs are ideal in the female patient who tends to have an acne vulgaris flare around the time of her menses or ovulation because of the ...