New research eyes OC in acne treatment
The next patient in your exam room is an adolescent female, who says she’s interested in birth control pills. Her chief focus? While she’s interested in contraception, she asks several questions about an "acne pill."
According to A Pocket Guide to Managing Contraception, all combined oral contraceptives (OCs) lower free testosterone due to their antiandrogenic compounds.1 However, only two pills — Ortho Tri-Cyclen (Ortho-McNeil Pharmaceutical, Raritan, NJ) and Estrostep (Warner Chilcott, Rockaway, NJ) — carry an approved indication from the Food and Drug Administration (FDA) for treatment of mild-to-moderate acne. Ortho Tri-Cyclen uses a combination of ethinyl estradiol and norgestimate, while Estrostep uses a mix of ethinyl estradiol and norethindrone acetate. Ortho Tri-Cyclen received its indication based on research published in 19972; Estrostep gained its approval on research published in 2001.3
Look for other OCs to seek similar acne indications; recently published research indicates that Yasmin (Berlex Laboratories, Montville, NJ), a combination of ethinyl estradiol and drospirenone, also is effective in treating the condition.4 Other OCs are now being evaluated for possible treatment of acne5; two trials involving Alesse (Wyeth-Ayerst Laboratories, Philadelphia) showed total acne improvement of 23%-40% compared with 9%-23% with placebo.6,7 Alesse relies on a combination of ethinyl estradiol and levonorgestrel.
Berlex Laboratories is conducting further research on potential use of Yasmin in acne treatment and awaits completion of those studies before filing with the FDA, says company spokes-woman Kimberly Schillace.
The Yasmin trial was designed as a double-blind study to compare the efficacy and tolerability of the drug. Ortho Tri-Cyclen was used as the comparison drug. Researchers at 56 international centers randomly assigned 1,154 women to use the study or the comparison drug. Of those who completed the study, 505 received Yasmin and 486 received Ortho Tri-Cyclen.
Investigators reported that Yasmin use resulted in a greater reduction of acne lesions than the comparison drug; in addition, researchers observed an improvement of overall facial acne in women receiving Yasmin compared to those using the comparison drug.2
The unique pharmacologic activities of drospirenone may have resulted in Yasmin’s performance, comments lead author Ian Thorneycroft, MD, professor of obstetrics and gynecology at the University of South Alabama and an obstetrician/gynecologist with the Bay Area Physicians for Women at Spring Hill Hospital, both in Mobile, AL.
Drospirenone first became available with the initial launch of Yasmin in Europe in 2000, followed by its U.S. launch in 2001. Scientists also are studying Yasmin’s antimineralocorticoid and anti-androgenic properties for potential use in treatment of premenstrual dysphoric disorder.
Canadian clinicians now may use Yasmin in their practices; the drug just received Canadian clearance for use as a contraceptive in January 2005.
U.S. clinicians may see a lower dose of the drug in 2005; Berlex submitted a New Drug Application in December 2003 for the new product. If approved by the FDA, the new version of Yasmin will contain 20 mcg ethinyl estradiol with 3 mg drospirenone.
If an adolescent chooses an OC strictly for use as an acne treatment, she may feel embarrassed about using a "birth control" pill. How should a clinician counsel for method success? Take a look at the following suggestions8:
- Discuss the fact that the Pill is a medical treatment, similar to drugs that are prescribed for other medical conditions. Consider the drug as a "hormone pill."
- Remind the adolescent that the Pill has additional noncontraceptive benefits, including period regulation, correction of hormonal imbalances, reduction of hirsutism, and prevention of iron deficiency anemia, pelvic inflammatory disease, and ectopic pregnancy. Oral contraceptives also help to decrease the risk of ovarian and endometrial cancers.
1. Hatcher RA, Zieman M, Cwiak C, et al. A Pocket Guide to Managing Contraception. Tiger, GA: Bridging the Gap Foundation; 2004.
2. Thorneycroft H, Gollnick H, Schellschmidt I. Superiority of a combined contraceptive containing drospirenone to a triphasic preparation containing norgestimate in acne treatment. Cutis 2004; 74:123-130.
3. Redmond GP, Olson WH, Lippman JS, et al. Norgestimate and ethinyl estradiol in the treatment of acne vulgaris: A randomized, placebo-controlled trial. Obstet Gynecol 1997; 89:615-622.
4. Maloney JM, Arbit DI, Flack M, et al. Use of a low-dose oral contraceptive containing norethindrone acetate and ethinyl estradiol in the treatment of moderate acne vulgaris. Clinical J Women’s Health 2001; 1:123-131.
5. Haider A, Shaw JC. Treatment of acne vulgaris. JAMA 2004; 292:726-735.
6. Thiboutot D, Archer DF, Lemay A, et al. A randomized, controlled trial of a low-dose contraceptive containing 20 microg of ethinyl estradiol and 100 microg of levonorgestrel for acne treatment. Fertil Steril 2001; 76:461-468.
7. Leyden J, Shalita A, Hordinsky M, et al. Efficacy of a low-dose oral contraceptive containing 20 microg of ethinyl estradiol and 100 microg of levonorgestrel for the treatment of moderate acne: A randomized, placebo-controlled trial. J Am Acad Dermatol 2002; 47:399-409.
8. Reproductive health issues for adolescents. Contraception Report 1997; 8:13-14.