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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).
Althoughmarketed as birth control since 1992, just in recent years hasOrtho 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 beingapproved as an acne treatment, and undergoing intensive marketingand advertising campaigns, Ortho Tri-Cyclen has become the numberone birth control pill on the market. (www.messenger-inquirer.com/yourhealth/e9981.htm)An advertisement calls Ortho Tri- Cyclen“the first pillproven to control blemishes as well as prevent pregnancy.”Does this mean that dermatologists should turn to prescribingbirth control to treat acne? Birth control pills are notthe only tool available to consumers looking to reduce outbreaks. And, even when treatments such as benzoyl peroxide and salicylicacid fail, Ortho Tri-Cyclen has not yet been proven effective inclearing up severe acne.
What causes acne?
The initial inciting event in the development of acne is theaction of androgens on the sebaceous gland to stimulate increasedsebum production. From there, the surface of the skin becomessticker from abnormal keratinization. This leads to the pluggingof the pores, trapping the sebum, and thus providing an idealmedium for bacterial growth. Inflammation results and eventuallyresolves the infection, but this process of wound healing oftencan lead to visible scaring. (http://www.ncbi.nlm.nih.gov/PubMed/) It is the highserum androgen levels that are associated with the presents ofacne in women, due to the increased androgen production in theovaries beginning with the onset of puberty. It is this androgenproduction that is combated by oral contraceptives.
Other causes of acne include thecollection of oil, bacteria, and dead skin cells that clog pores,stress, pollution, excess humidity, and excessive touching of theface by the hands or hair. Some medications such asandrenocorticotropic hormones, certain corticosteroids,androgens, phenytoin, lithium isoniazid and cyclosporine are alsoknown offenders (Journal of Oral and Maxillofacial Surgery, 1998May).
What are the side effects?
The use of Ortho Tri-Cyclen is consistent with known risksassociated with the use of oral contraceptives including stroke,blood clots, myocardial infarction, gall bladder disease,thromboembolism, nausea, weight gain, headaches, and irregularbleeding. (www.ama-assn.org/special/contra/ortho/cyclen.htm) In addition to the side effects listed above, women who use oralcontraception should not smoke. Each month supply of birthcontrol pills is accompanied by a warning that illustratessmoking hazards saying,“Cigarette smoking increases therisk of serious adverse side effects on the heart and bloodvessels from oral contraception use.”
Women whosuffer from high blood pressure, diabetes, high cholesterol andthose who have or have had clotting disorders, heart attack,stroke, angina pectoris, cancerof the breast or sex organs,jaundice, or liver tumors also associate themselves with asignificant increase of risk when taking oral contraceptives.
Though the use of oral contraceptives carry with them someadverse effects, they too are associated with severalnoncontraceptive benefits. According to Redmond (1998), oralcontraceptives provide significant protection against ovariancancer, and against conditions such as pelvic inflammatorydisease and ectopic pregnancy. They are also helpful inprotecting women against conditions that affect their quality oflife such as dysmenorrhea, and menorrhagia, as well as thebenefit of acne treatment.
Whatdoes the scientific research say?
Although other birth control pills, includingsome manufactured by Ortho-McNeil, are thought to be just aseffective in their success at warding off acne, none is able tocarry such a claim until their developers research to prove it.In two, double blind, placebo controlled, six month, multicenterclinical trials, commissioned by Ortho-McNeil, the participantstaking Ortho Tri-Cyclen showed a statistically significantdecrease in inflammatory lesion count, and total lesion countand, more impressively, acne improved in 80 percent of users. (www.ama-assn.org/special/contra/ortho/cyclen.htm) According to a research article inContraception,thisstudy required a placebo control because acne is a condition thatcan vary in severity over time and patients participating in thisstudy are more likely to be careful about their skin hygiene,resulting in regression to the mean. For these reasons, and dueto the large expected placebo effect, a controlled experimentaldesign is essential. In these two studies, 462 patients at 20sites across the United States were randomized into two groups,one received Ortho Tri-Cyclene, and the other was given colormatched placebo tablets. All subjects agreed to use nonhormonalcontraception as a backup method and to practice the same skincare regime, which included the use of a mild soap and anoncomedogenic (non-pore clogging) moisturizer containingsunscreen. They were followed for six treatment cycles, andassessed after months one, three and six. Of the 462 women in thestudy, 75% of the active group (n=163) and 68% of the placebogroup (n=161) retained its members. At the end of six months,both groups showed a significant decline in total lesions; theplacebo group showed a 30% decrease (not atypical as a result ofthe placebo affect), whereas the oral contraception users showeda much greater decrease, reduced on average by 49.6% or one-half.For inflammatory lesions, decreases of 36.6% and 56.6% were therespective results. Among patients who received activetreatment, 88.3% reported excellent, good or fair improvement, ofwhich 31.9% reported excellent results. By every variablemeasured, Ortho Tri-Cyclen treatment produced marked improvementin mean patient condition. Furthermore, visible improvements ofthe skin may also lead to enhanced compliance and a greatercontinuation rate by many users, (Redmond, 1998). As a result,the Ortho McNeil Pharmaceutical company concluded that theirtriphasic combination of norgestimate and ethinyl estradiollengthens the time interval to recurrence of acne lesions (Int JFertil Womens Med, 1998).
The Dermatology Research AssociatesInc., and the Foundation for Developmental Endocrinology, Inc.,followed the same study and both affirmed that“an oralcontraception containing .035mg of ethinyl estradiol combinedwith the triphasic regime of norgestimate is a safe and effectivetreatment for mild to moderate acne vulgaris in women with noknown contradiction to oral contraceptive therapy,”(ObstetGynecol 1997&J Am Acad Dermatol 1997). Furthermore, freetestosterone decreased significantly and sex hormone-bindingglobulin increased significantly in the active group, butremained unchanged in the control group. The Ortho McNeilstudy, evaluating the efficacy of the norgestimate/ethinylestradiol combination is the only found research designevaluating such, though several journals who followed the studyconcluded in favor of this drug as an effective treatment foracne. In 1998,Dermatologyconfirmed that a possible causefor acne is an adrenal enzymatic block of which the onlytreatment is hormonal.
In a 1998 cohort study to determinethe use of oral contraception for contraception and acne, ninthgrade secondary school girls answered a questionnaire on theirmenstrual cycle. Of the 2248 responders, 10% mentioned acne asthe most important reason for the use of oral contraception (ActaObstet Gynecol Scand, 1998). This confirms that anincreasing number for young women are seeking oral contraceptionmerely for it acne-reducing effects.
Each of the studies illustrates improvement ofacne among oral contraception users, though hormonal treatment isnot the first line of defense in female acne. However, OrthoTri-Cyclen is a good choice for women seeking acne treatment whoare already using oral contraceptives. Oral antibiotics, liketetracycline, doxycycline or monocycline, which may be a betterchoice for women not using birth control, are not options forthose women who do because they diminish the effectiveness oforal contraceptive protection against pregnancy. While OrthoTri-Cyclen’s wide spread advertisements and highprescription rate have caused little concern among gynecologists,many dermatologists prescribe birth control with reservation fortreating acne. Dr. Seth Matarasso, a San Francisco dermatologistsays that he tries topical creams and antibiotics first, thenprescribes Ortho Tri-Cyclen only after discussing the systemicmedication with the patient, her parents, and her gynecologist. (www.mojones.com/mother_jones/MA98/lloyd.html)Some health professionals have mixed feelings about theremarkable success of Ortho Tri-Cyclen, worrying that women arecompromising good birth control decisions in order to gain thepromised pimple-free skin. Seemingly, patients are lessinterested in discussing side effects of brand specific birthcontrol pills than in“buying what Madison Avenue tells themto”. (www.messenger-inquirer.com/yourhealth/e9981.htm)Magazines such as Glamour and Shape feature multipageadvertisements, using up-close photos of beautiful models to plugthe promise to clear up skin while staying baby free. The bottomline, according to Dr. Elena Gates, chief OB-GYN at Mount ZionMedical Center in California, is that Ortho Tri-Cyclen is a primeexample of a“good new drug,”reminding consumers thatindividual results tend to vary, and acknowledges,“You needto be cautious that advertisers aren’t creating a need whereone doesn’t exist.”Ortho Tri-Cyclen does improve theappearance of acne in most people, but unless its contraceptiveeffects are likewise desired, maybe seeking other anti-acneproducts first would serve as an effective measure for treatment.
Beylot C, Doutre MS, Beylot-Barry M, (1998).Oral contraceptives and cyproterone acetate in female acnetreatment.Dermatology, 196(1), 148-52
Lucky AW, Henderson TA, Olson WH, Robisch DM,Lebwohl M, Swinyer LJ, (1997). Effectiveness of norgestimate andethinyl estradiol in treating moderate acne vulgaris.Journalof American Acad Dermatology, 37(5Pt1), 746-54
Olson WH, Lippman JS, Robisch DM, (1998). Theduration of response to norgestimate and ethinyl estradiol in thetreatment of acne vulgaris.Internal Journal of Fertil WomensMed,43(6), 286-90
Redmond GP, (1998). Effectiveness of oralcontraceptives in the treatment of acne,Contraception,58(3 Suppl), 29S-33S
Redmond GP, Olson WH, Lippman JS, KafrissenME, Jones TM, Jorizzo JL, (1997). Norgestimate and ethinylestradiol in the treatment of acne vulgaris: a radomized, placebocontrolled 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 oralcontraceptives by adolescents for contraception, menstrual cycleproblems or acne.Acta Obstetrics and Gynecol Scand,77(9), 898-904
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