Low-Dose OCs File With FDA for Acne Indication

OB/GYN News, June 15, 2001 by Kathryn Demott

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 effect of hormones on oil-forming glands. In these patients, OCs are a good adjunct to topical retinoids, and they can be continued long after the topical therapy is discontinued. In patients with severe acne vulgaris with the potential for scarring, Dr Berson said she uses isotretinoin (Accutane). But even then, OCs can be an adjunct in women who have a cyclic hormonal component to their flares.

Many of the OCs on the market clear acne, although they don't have an FDA indication for treating it, she added.

In the Estrostep study, women in the OC group had a 56% reduction in inflammatory lesions by the end of six cycles, compared with a 46% reduction among patients in the placebo group. Comedones were also reduced by 39% in the OC group and 25% in the placebo group.

Overall, 48% of patients in the OC group had no lesions or had minimal or mild lesions, compared with 33% of the placebo group, at the end of the study.

The incidence of breakthrough bleeding was more common in the OC group (17%), compared with the placebo group (2%).

In a separate randomized, placebo-controlled study of 371 women presented at the annual meeting of the American Academy of Dermatology, those who received 20 [micro]g of ethinyl estradiol and 100 [micro]g of levonorgestrel (Alesse) for up to six cycles had greater clearance of acne lesions than those on placebo. The mean percent change in total lesion count was significantly lower for the active treatment group than for the placebo group (-29.7% vs. -9.1%).

The mean percent changes in inflammatory and noninflammatory lesions also differed significantly (-41.5% vs. -27.9% and -18.3% vs. -9.12%, respectively).

Clinicians rated 57% of the active treatment group as "clear/almost clear" at week 6. Among subjects in the placebo group, 47% achieved this rating.