What is the Pill's role in reducing acne?
Your next patient is a 17-year-old female, who says she is interested in using an oral contraceptive (OC) to help control her acne. How do you discuss the use of the Pill in her acne treatment?
Acne is among the most common of all dermatologic conditions, affecting 85% of people ages 15 to 24.1 Use of oral contraceptives represents one strategy in treating mild to moderate cases of the dermatologic condition.
Combined OCs prevent acne through several mechanisms. They reduce the production of the androgen testosterone by suppressing luteinizing hormone.2 Androgen bioavailability also is reduced due to an increase in the level of sex hormone-binding globulin, which binds free androgens. Oral contraceptives act on multiple sites to decrease the total and free androgen levels, and they ultimately lead to a reduction in sebum production.1
The Pill has been the focus of several studies in acne treatment3 and has been shown to be effective alone or in combination with other oral or topical treatments.
All combined oral contraceptives lower free testosterone, point out the authors of Contraceptive Technology.4 In the United States, 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 1997.5 Estrostep gained its approval on research published in 2001.6 Yasmin, a combination of ethinyl estradiol and drospirenone (Berlex Laboratories; Montville, NJ), and Alesse, an ethinyl estradiol/levonorgestrel pill from Philadelphia-based Wyeth-Ayerst Laboratories, are under review for possible acne indications.
Scientists in Europe have just reported results from a Phase 3 study designed to evaluate the efficacy and safety of Belara, a monophasic pill with 2 mg chlormadinone acetate (CMA) and 0.03 mg ethinyl estradiol. In the study, the formulation appeared superior to placebo in the treatment of acne of the face, décolleté and back, as well as treatment of seborrhea.7
The pill, manufactured by Grünenthal GmbH in Aachen, Germany, is available in many European countries, including Germany, France, Spain, and Italy, as well as many Latin American countries, including Chile, Peru, Ecuador, Mexico, and Colombia. Will U.S. clinicians see this formulation?
"In the United States, CMA is a nearly unknown substance that requires significant effort for clinical development in order to obtain regulatory approval," says Anke Krüger-Hellwig, company spokeswoman. In addition, Grünenthal has no presence in the U.S. market, she says. "Due to these facts, Grünenthal is currently not in the position to communicate any accurate dates for availability of Belara in the U.S."
Adolescents wonder, but don't always ask, how soon they can expect to see benefits from OCs on their acne, says Paula J. Adams Hillard, MD, professor in the departments of obstetrics/gynecology and pediatrics at the University of Cincinnati College of Medicine. Clinicians should encourage adolescent patients to allow at least three months to assess the benefits of the Pill when it comes to acne treatment, she advises.
With acne, teens may notice initially that they do not experience a premenstrual "flare" of acne, says Hillard, so patients should be advised to continue all other acne medications, such as antibiotics and topical medications, during the initial three months of OC use, she suggests.
3-month checkup: Assess benefits
A three-month checkup is a good time to assess the benefits from OCs, says Hillard. Patients also may want to plan a follow-up visit with their dermatologist or primary clinician as well. Sometimes systemic antibiotics can be discontinued after the three-month visit. If the acne is of such a severe nature that isotretinoin (Accutane; Hoffman-La Roche; Nutley, NJ) may be required, the three-month checkup period is a good time for the dermatologist to assess whether to initiate this therapy, she adds.
Teens may think that topical medications can be discontinued when they begin using the Pill, but encourage patients to continue their use, says Hillard. "Sometimes prior to initiating OCs, patients will have discontinued topical medications," she notes. "At the initial visit during which OCs are started, I typically urge them to reinstitute the topical medications, giving the rationale that they act differently from OCs."
If you are evaluating an adolescent patient for possible acne treatment with OCs, consider whether or not the patient meets the criteria for polycystic ovary syndrome (PCOS) or androgen excess disorders spectrum, says Hillard.
"Girls with severe acne often have other signs of androgen excess and may have irregular menses or obesity," advises Hillard. "Initiating OCs for acne without considering this diagnosis makes it less likely that there will be a discussion or recognition of the health risks of overweight/obesity or the risks of medical sequelae associated with PCOS, insulin resistance, diabetes, and metabolic syndrome."
1. Deitch HR, Hillard PJA. A gynecologist's guide to acne. Contemporary OB/GYN 2002; 1:88-99.
2. Thorneycroft IH, Stanczyk FZ, Bradshaw KD, et al. Effect of low-dose oral contraceptives on androgenic markers and acne. Contraception 1999; 60:255-262.
3. Arowojolu AO, Gallo MF, Grimes DA, et al. Combined oral contraceptive pills for treatment of acne. Cochrane Database Syst Rev 2004; (3):CD004425.
4. Hatcher RA, Trussell J, Stewart F, et al. Contraceptive Technology: 18th revised edition. New York City: Ardent Media; 2004.
5. 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.
6. 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.
7. Gaspard UJ. Belara. A new opportunity in contraception. Presented at the 9th Congress of the European Society of Contraception. Istanbul, Turkey; May 2006.