Ortho Tri-Cyclen and Acne
by
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?
Conclusion
References
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).
Norgestimate
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.
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
