Ortho Tri-Cyclen and Acne


Jessica Slenger

What does Ortho Tri-Cyclen do for the treatment of acne and how does it work?

What causes acne?

What are the side effects?

What does the scientific research say?







What does Ortho Tri-Cyclen do for the treatment of acne and how does it work?

            In 1960, the medical world of the United States was revolutionized by the introduction of The Pill.  For the past forty years, The Pill has been the most popular form of reversible birth control. But beside the stellar contraceptive effectiveness rate ranging from 97-99.9% (when taken as directed), many other non-contraceptive benefits exist in conjunction with this method of birth control. Studies have proven that a women’s incidence of ovarian and endometrial cancers, benign cysts of the ovaries and breasts, and pelvic inflammatory disease, all decrease with pill use. Heavy bleeding and severe cramps are also minimized (www.fda.gov/bbs/topics/CONSUMER/CON00027.html). Recent claims state that birth control may also effectively treat some types of acne. Though, back in 1966, The Rocky Mountain Medical Journal published an article illustrating the effectiveness of estrogen-progestin combination in the treatment of stubborn acne, and maintaining that the cyclic administration of oral contraception is a useful measure for many women.

It was not until January 2, 1997 that marked another big step in the world of the birth control pill when, for the first time, an oral contraceptive was approved for marketing by the United States Food and Drug Administration (FDA) as an effective treatment for acne. Ortho Tri-Cyclen, originally introduced in 1992 by the Ortho-McNeil Pharmaceutical Corporation, is the first low dose birth control pill approved for a noncontraceptive indication. (www.pslgroup.com/dg/fa6a/htm.) Ortho Tri-Cyclen is the only birth control pill that has been clinically proven for the treatment of moderate vulgaris acne, in women ages 15 or older, who menstruate, are unresponsive to other topical or oral anti-acne medications and show no medical reasons prohibiting their use of oral contraceptives. Studies show that 9 out of 10 women who took Ortho Tri-Cyclen saw significant improvements in their skin. (www.//ortho-mcneil.com/orthotri-cyclen/info/goodforyourskin.htm)  Ortho Tri-Cyclen differs from other birth control pills because it contains estrogen (which is thought to decrease the level of other hormones that contribute to the development of acne producers) along with a patented brand of progestin, norgestimate, which does not have a dimming effect on the estrogen’s acne-reducing benefits. These two principal components are the main reason Ortho Tri-Cyclen is effective in the treatment of acne. (www.messenger-inquire.com/yourhealth/e9981.htm) Along with the combination of ethinly estradiol, which may increase sex hormone binding globulin (SHGB) and lessen resulting free testosterone, the severity of facial acne is decreased by lowering levels of serum free hormones that contribute to acne breakouts in otherwise healthy women. (www.ama-assn.org/special/contra/ortho/cyclen.htm) The Ortho formulation with low androginicity as a treatment of acne is also effective due to the triphasic approach of administering the norgestimate (.18, .215, .25 ug) plus ethinyl estradiol (35 ug). Therefore, Ortho Tri-Cyclen helps promote clear skin without compromising the effectiveness of pregnancy prevention (like oral acne medications such as tetracycline can do).










                                                                                                    Ethinyl Estradiol


Although marketed as birth control since 1992, just in recent years has Ortho Tri-Cyclen sales skyrocketed. According to IMS Health, before the FDA approved it for the treatment of acne, Ortho Tri- Cyclen ranked seventh among popular birth control. After being approved as an acne treatment, and undergoing intensive marketing and advertising campaigns, Ortho Tri-Cyclen has become the number one birth control pill on the market. (www.messenger-inquirer.com/yourhealth/e9981.htm) An advertisement calls Ortho Tri- Cyclen “the first pill proven to control blemishes as well as prevent pregnancy.” Does this mean that dermatologists should turn to prescribing birth control to treat acne?  Birth control pills are not the only tool available to consumers looking to reduce outbreaks.  And, even when treatments such as benzoyl peroxide and salicylic acid fail, Ortho Tri-Cyclen has not yet been proven effective in clearing up severe acne.

What causes acne?

            The initial inciting event in the development of acne is the action of androgens on the sebaceous gland to stimulate increased sebum production. From there, the surface of the skin becomes sticker from abnormal keratinization. This leads to the plugging of the pores, trapping the sebum, and thus providing an ideal medium for bacterial growth. Inflammation results and eventually resolves the infection, but this process of wound healing often can lead to visible scaring. (http://www.ncbi.nlm.nih.gov/PubMed/) It is the high serum androgen levels that are associated with the presents of acne in women, due to the increased androgen production in the ovaries beginning with the onset of puberty. It is this androgen production that is combated by oral contraceptives.

Other causes of acne include the collection of oil, bacteria, and dead skin cells that clog pores, stress, pollution, excess humidity, and excessive touching of the face by the hands or hair. Some medications such as andrenocorticotropic hormones, certain corticosteroids, androgens, phenytoin, lithium isoniazid and cyclosporine are also known offenders (Journal of Oral and Maxillofacial Surgery, 1998 May).

What are the side effects?


The use of Ortho Tri-Cyclen is consistent with known risks associated with the use of oral contraceptives including stroke, blood clots, myocardial infarction, gall bladder disease, thromboembolism, nausea, weight gain, headaches, and irregular bleeding. (
www.ama-assn.org/special/contra/ortho/cyclen.htm)  In addition to the side effects listed above, women who use oral contraception should not smoke. Each month supply of birth control pills is accompanied by a warning that illustrates smoking hazards saying, “Cigarette smoking increases the risk of serious adverse side effects on the heart and blood vessels from oral contraception use.”


Women who suffer from high blood pressure, diabetes, high cholesterol and those who have or have had clotting disorders, heart attack, stroke, angina pectoris, cancer of the breast or sex organs, jaundice, or liver tumors also associate themselves with a significant increase of risk when taking oral contraceptives.

            Though the use of oral contraceptives carry with them some adverse effects, they too are associated with several noncontraceptive benefits. According to Redmond (1998), oral contraceptives provide significant protection against ovarian cancer, and against conditions such as pelvic inflammatory disease and ectopic pregnancy. They are also helpful in protecting women against conditions that affect their quality of life such as dysmenorrhea, and menorrhagia, as well as the benefit of acne treatment.

What does the scientific research say?

Although other birth control pills, including some manufactured by Ortho-McNeil, are thought to be just as effective in their success at warding off acne, none is able to carry such a claim until their developers research to prove it. In two, double blind, placebo controlled, six month, multicenter clinical trials, commissioned by Ortho-McNeil, the participants taking Ortho Tri-Cyclen showed a statistically significant decrease in inflammatory lesion count, and total lesion count and, more impressively, acne improved in 80 percent of users. (www.ama-assn.org/special/contra/ortho/cyclen.htm)  According to a research article in Contraception, this study required a placebo control because acne is a condition that can vary in severity over time and patients participating in this study are more likely to be careful about their skin hygiene, resulting in regression to the mean. For these reasons, and due to the large expected placebo effect, a controlled experimental design is essential. In these two studies, 462 patients at 20 sites across the United States were randomized into two groups, one received Ortho Tri-Cyclene, and the other was given color matched placebo tablets. All subjects agreed to use nonhormonal contraception as a backup method and to practice the same skin care regime, which included the use of a mild soap and a noncomedogenic (non-pore clogging) moisturizer containing sunscreen. They were followed for six treatment cycles, and assessed after months one, three and six. Of the 462 women in the study, 75% of the active group (n=163) and 68% of the placebo group (n=161) retained its members. At the end of six months, both groups showed a significant decline in total lesions; the placebo group showed a 30% decrease (not atypical as a result of the placebo affect), whereas the oral contraception users showed a much greater decrease, reduced on average by 49.6% or one-half. For inflammatory lesions, decreases of 36.6% and 56.6% were the respective results.  Among patients who received active treatment, 88.3% reported excellent, good or fair improvement, of which 31.9% reported excellent results. By every variable measured, Ortho Tri-Cyclen treatment produced marked improvement in mean patient condition. Furthermore, visible improvements of the skin may also lead to enhanced compliance and a greater continuation rate by many users, (Redmond, 1998). As a result, the Ortho McNeil Pharmaceutical company concluded that their triphasic combination of norgestimate and ethinyl estradiol lengthens the time interval to recurrence of acne lesions (Int J Fertil Womens Med, 1998).

The Dermatology Research Associates Inc., and the Foundation for Developmental Endocrinology, Inc., followed the same study and both affirmed that “an oral contraception containing .035mg of ethinyl estradiol combined with the triphasic regime of norgestimate is a safe and effective treatment for mild to moderate acne vulgaris in women with no known contradiction to oral contraceptive therapy,” (Obstet Gynecol 1997 & J Am Acad Dermatol 1997). Furthermore, free testosterone decreased significantly and sex hormone-binding globulin increased significantly in the active group, but remained unchanged in the control group.  The Ortho McNeil study, evaluating the efficacy of the norgestimate/ethinyl estradiol combination is the only found research design evaluating such, though several journals who followed the study concluded in favor of this drug as an effective treatment for acne. In 1998, Dermatology confirmed that a possible cause for acne is an adrenal enzymatic block of which the only treatment is hormonal.

In a 1998 cohort study to determine the use of oral contraception for contraception and acne, ninth grade secondary school girls answered a questionnaire on their menstrual cycle. Of the 2248 responders, 10% mentioned acne as the most important reason for the use of oral contraception (Acta Obstet Gynecol Scand, 1998).  This confirms that an increasing number for young women are seeking oral contraception merely for it acne-reducing effects.


Each of the studies illustrates improvement of acne among oral contraception users, though hormonal treatment is not the first line of defense in female acne. However, Ortho Tri-Cyclen is a good choice for women seeking acne treatment who are already using oral contraceptives. Oral antibiotics, like tetracycline, doxycycline or monocycline, which may be a better choice for women not using birth control, are not options for those women who do because they diminish the effectiveness of oral contraceptive protection against pregnancy. While Ortho Tri-Cyclen’s wide spread advertisements and high prescription rate have caused little concern among gynecologists, many dermatologists prescribe birth control with reservation for treating acne. Dr. Seth Matarasso, a San Francisco dermatologist says that he tries topical creams and antibiotics first, then prescribes Ortho Tri-Cyclen only after discussing the systemic medication with the patient, her parents, and her gynecologist. (www.mojones.com/mother_jones/MA98/lloyd.html) Some health professionals have mixed feelings about the remarkable success of Ortho Tri-Cyclen, worrying that women are compromising good birth control decisions in order to gain the promised pimple-free skin. Seemingly, patients are less interested in discussing side effects of brand specific birth control pills than in “buying what Madison Avenue tells them to”. (www.messenger-inquirer.com/yourhealth/e9981.htm) Magazines such as Glamour and Shape feature multipage advertisements, using up-close photos of beautiful models to plug the promise to clear up skin while staying baby free. The bottom line, according to Dr. Elena Gates, chief OB-GYN at Mount Zion Medical Center in California, is that Ortho Tri-Cyclen is a prime example of a “good new drug,” reminding consumers that individual results tend to vary, and acknowledges, “You need to be cautious that advertisers aren’t creating a need where one doesn’t exist.” Ortho Tri-Cyclen does improve the appearance of acne in most people, but unless its contraceptive effects are likewise desired, maybe seeking other anti-acne products first would serve as an effective measure for treatment.


Beylot C, Doutre MS, Beylot-Barry M, (1998). Oral contraceptives and cyproterone acetate in female acne treatment. Dermatology, 196(1), 148-52


Lucky AW, Henderson TA, Olson WH, Robisch DM, Lebwohl M, Swinyer LJ, (1997). Effectiveness of norgestimate and ethinyl estradiol in treating moderate acne vulgaris. Journal of American Acad Dermatology, 37(5Pt1), 746-54


Olson WH, Lippman JS, Robisch DM, (1998). The duration of response to norgestimate and ethinyl estradiol in the treatment of acne vulgaris. Internal Journal of Fertil Womens Med, 43(6), 286-90


Redmond GP, (1998). Effectiveness of oral contraceptives in the treatment of acne, Contraception, 58(3 Suppl), 29S-33S


Redmond GP, Olson WH, Lippman JS, Kafrissen ME, Jones TM, Jorizzo JL, (1997). Norgestimate and ethinyl estradiol in the treatment of acne vulgaris: a radomized, placebo controlled trial. Obstetrics and Gynecology, 89(4), 615-22


Van Hoff MH, Hirasing RA, Kaptein MB, Koppenaal C, Voorhorst FJ, Schoemaker J, (1998). The use of oral contraceptives by adolescents for contraception, menstrual cycle problems or acne. Acta Obstetrics and Gynecol Scand, 77(9), 898-904


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