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Systemic Acne Treatments for Women

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I found the below article in the June 2002 issue of Skin and Allergy

News. It describes oral contraceptives, accutane and antibiotics.

Hope someone finds this useful.

Take care,

Matija

Drug Update: Systemic Acne Treatments for Women

Mitchel L. Zoler, editor

Heidi Splete, writer

The road to clear skin is getting shorter. Recent Food and Drug

Administration approval of several oral contraceptives for the

treatment of mild to moderate acne has expanded the systemic

treatment options for women. In addition, a flurry of direct-to-

consumer advertising may send more women to their primary care

physicians or gynecologists seeking prescriptions for acne

medications.

As dermatologists know and primary care physicians are learning, acne

is prevalent among adults, especially women. Women are becoming

increasingly aware of their treatment options and are actively

seeking them rather than hoping that the condition will resolve on

its own. Physicians can treat adult acne with oral or topical agents,

or a combination of both, but it's important to tailor treatment to

the patient's type of acne. Oral contraceptives and antibiotics are

good for inflammatory acne. Oral or topical retinoids, such as

isotretinoin, are best for treating severe nodular acne. Treatment

should also be dictated by severity; no treatment protocol is best

for everyone.

All drugs listed should be avoided during pregnancy and by women who

are breast-feeding. Women aged 35 or older who smoke should not take

oral contraceptives.

----------------------------------------------------------------------

ORAL CONTRACEPTIVES

This class treats inflammatory acne on a hormonal level by reducing

androgen production and circulating androgens. Some study results

have shown increased levels of androgens in women with acne, but the

exact relationship between acne and the menstrual cycle remains

elusive. Many women with acne also have hyperandrogenic symptoms,

such as irregular periods, oily skin, and mild hirsutism.

OCs can be effective for mild to moderate acne but are often

ineffective for more severe cases. They're a good choice for women

with mild to moderate acne who also want contraception. Daily use is

necessary. Some OCs have been specifically tested and approved for

treating acne, while others have not. Some oral contraceptives, those

with larger androgen doses, are bad for acne. All three OCs listed

are equally safe and have not been tested head-to-head. Hormonal

manipulation helps resolve the acne but also causes many side

effects, so an element of trial and error is involved. Limit side

effects by cutting the estrogen dose. A patient with bloating or

nausea may find a lower dose more tolerable; a patient with

breakthrough bleeding may need a higher dose. Other oral

contraceptives probably have similar safety and efficacy, but

physicians may feel more comfortable prescribing one with FDA

approval for acne. If used with one of the antibiotics listed below,

advise a second method of birth control because of concern that

antibiotics may negate estrogen's contraceptive effect.

Drug Daily Dosage Cost/Day* Comment**

norgestimate and ethinyl estradiol (Ortho Tri-Cyclen) 180-250 µg

norgestimate and 35 µg ethinyl estradiol $1.11 First birth control

pill with FDA approval for acne. Contains 35 µg of estrogen.

Generally well tolerated.

norethindrone acetate and ethinyl estradiol (Estrostep) 1 mg

norethindrone acetate and 20-35 µg ethinyl estradiol $1.18 Approved

by the FDA for treating moderate acne. Formulated so that ethinyl

estradiol dose rises as pills are used during a cycle, starting at 20

µg/day early in cycle and increasing to 30 µg/day and then to 35

µg/day. May be better tolerated in some women than alternative

formulations. Currently the lowest estrogen dose with FDA approval

for acne.

levonorgestrel and ethinyl estradiol (Alesse) 100 µg levonorgestrel

and 20 µg ethinyl estradiol $1.13 Application for acne indication

submitted to FDA in January 2001; approval expected this year.

Delivers 20 µg of ethinyl estradiol daily throughout cycle, making it

the lowest-estrogen formulation. May be better tolerated in women

with bloating or nausea on higher-dose formulations.

----------------------------------------------------------------------

OTHER SYSTEMIC AGENTS

Drug Daily Dosage Cost/Day* Comment**

tetracycline 1 g $0.22 Effective for moderate inflammatory acne, but

an oral contraceptive may be a better choice if acne seems to have a

hormonal influence. Tetracycline resolves moderate acne, precluding

need for isotretinoin, which has more side effects. Some patients

have success using tetracycline plus birth control pills. May disrupt

effectiveness of birth control pills, so additional contraception

should be used. Tetracycline dosage varies widely. Patients whose

acne is mostly under control can get by on 250 mg/day. Avoid in women

who are pregnant or breast-feeding and in women taking isotretinoin;

not recommended for women over 40 with vascular problems. Can't be

taken immediately before or after eating, which makes compliance

challenging. May cause photosensitivity, so patients on tetracycline

must use sun protection.

doxycycline 150 mg $0.87 (doxycycline hyclate); $3.72 (doxycycline

monohydrate) Tetracycline-related antibiotic that's more convenient

for some patients since it can be taken with food and milk. Taking at

breakfast and dinner increases compliance, although taking at bedtime

can cause indigestion. Downside is more pronounced phototoxicity than

tetracycline and higher cost. Can't be prescribed to patients taking

isotretinoin. May disrupt effectiveness of birth control pills, so

additional contraception should be used. Two forms of doxycycline

exist: the hyclate salt and the monohydrate salt. Safety and efficacy

are similar, but there is a substantial price difference and the

monohydrate causes fewer gastrointestinal side effects.

minocycline 75-100 mg $4.66 (100 mg b.i.d.) Most recent drug

available in tetracycline class. More effective than other drugs in

class, but also more expensive. Reports of liver toxicity and

photosensitivity with use. Usually reserved for acne that does not

respond to other antibiotics. May disrupt effectiveness of birth

control pills, so additional contraception should be used.

isotretinoin (Accutane) 1-2 mg/kg $19.50 (40 mg b.i.d.) Very

effective for treating nodular cystic acne but has most severe side

effects of any systemic acne treatment. Discuss potential adverse

effects thoroughly with patients before prescribing. Because of

teratogenic risk, women of child-bearing age taking isotretinoin

should use two forms of contraception to prevent pregnancy. If

patient isn't already using an oral contraceptive, physician may want

to suggest a formulation approved for acne treatment. To curb the

number of women who become pregnant while on isotretinoin, the

manufacturer launched an intensive education and control program

early this year aimed at physicians and pharmacists. Dosage is

divided and taken twice a day; course of treatment is about 5 months.

If side effects appear, lower the daily dosage and extend the

treatment period to deliver the full regimen. Patients on

isotretinoin must avoid tetracycline, doxycycline, and minocycline,

which raise the risk of pseudotumor cerebri.

*Cost/day is based on the average wholesale price in the 2001 Red

Book for a 100-unit container or closest available size of the

generic formulation, unless otherwise specified.

**Comments reflect the opinions and expertise of the following

sources:

Dr. Diane Berson, director of dermatology, Iris Cantor Women's Health

Center, and assistant professor of dermatology, Cornell University,

New York.

Dr. R. Nunley, associate professor of dermatology, Virginia

Commonwealth University, Richmond.

Dr. Alan R. Shalita, chairman and distinguished teaching professor,

department of dermatology, State University of New York Downstate

Medical Center, Brooklyn.

Dr. C. Shaw, associate professor, division of dermatology,

University of Toronto.

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