TherapyEfficacy of a low-dose oral contraceptive containing 20 μg of ethinyl estradiol and 100 μg of levonorgestrel for the treatment of moderate acne: A randomized, placebo-controlled trial☆,☆☆,★
Section snippets
Study population
Participants enrolled at 18 investigational sites were healthy women, at least 14 years of age, with regular menstrual cycles and moderate facial acne. Moderate facial acne was defined as a total facial count of 6 to 200 noninflammatory comedones, 10 to 75 inflammatory lesions (papules and pustules), and 5 or fewer nodules. Participants were required to have discontinued long-term retinoid therapy (oral or topical) for 6 weeks before enrollment, systemic antibiotics and other systemic acne
Patient disposition
A total of 371 patients were enrolled, with 185 randomly assigned to EE/LNG and 186 assigned to placebo. Two hundred forty-six patients completed the study and a similar number of patients discontinued treatment in both groups. The two most common reasons for discontinuation were “lost to follow-up” (EE/LNG, n = 11; placebo, n = 26) and “personal reason” (EE/LNG, n = 22; placebo, n = 13); significantly more patients in the placebo group than in the EE/LNG group were “lost to follow-up.”
Demographic and baseline characteristics
Discussion
This is one of two34 placebo-controlled trials demonstrating that a low-dose OC containing 20 μg of EE and 100 μg of LNG is efficacious and safe for the treatment of moderate acne vulgaris. Significantly greater reductions in total, inflammatory, and noninflammatory acne lesions were observed in patients treated with EE/LNG than in patients who received placebo, despite an impressive placebo response. For patients in the EE/LNG group, CGA scores were also significantly better compared with
Acknowledgements
We thank the additional investigators who participated in the study: PonJola Coney, MD, Douglass Forsha, MD, Michael Jarratt, MD, Steven Kempers, MD, Nellie Konnikov, MD, Richard G. B. Langley, MD, Anne Lucky, MD, Daniel Piacquadio, MD, Walter Powell, MD, David Rodriguez, MD, Hans Sander, MD, Daniel Stewart, DO, Edwardo Tschen, MD, and Guy Webster, MD, PhD. We also thank Robert Northington, PhD, and Dayong Li, PhD, for statistical analyses, and Kathleen Ohleth, PhD, for editorial assistance.
References (60)
- et al.
Plasma androgens in women with acne vulgaris
J Invest Dermatol
(1983) - et al.
Differential rates of conversion of testosterone to dihydrotestosterone in acne and in normal skin: a possible pathogenic factor in acne
J Invest Dermatol
(1971) Antiandrogen and hormonal treatment of acne
Dermatol Clin
(1996)- et al.
Cyproterone acetate/ethinyl estradiol in the treatment of acne: a comparative dose-response study of the estrogen component
Contraception
(1990) - et al.
Divergent effects of two low-dose oral contraceptives on sex hormone-binding globulin and free testosterone
Am J Obstet Gynecol
(1987) - et al.
Effects of seven low-dose combined oral contraceptives on sex hormone binding globulin, corticosteroid binding globulin, total and free testosterone
Contraception
(1990) - et al.
Effect of low-dose oral contraceptive on gonadotropins, androgens, and sex hormone binding globulin in nonhirsute women
Fertil Steril
(1990) - et al.
Changes in androgens during treatment with four low-dose contraceptives
Contraception
(1996) - et al.
Effect of low-dose oral contraceptives on androgenic markers and acne
Contraception
(1999) - et al.
Clinical and hormonal effects of ethinylestradiol combined with gestodene and desogestrel in young women with acne vulgaris
Contraception
(1996)
Effectiveness of norgestimate and ethinyl estradiol in treating moderate acne vulgaris
J Am Acad Dermatol
Norgestimate and ethinyl estradiol in the treatment of acne vulgaris: a randomized, placebo-controlled trial
Obstet Gynecol
A new low-dose monophasic combination oral contraceptive (Alesse®) with levonorgestrel 100 μg and ethinyl estradiol 20 μg
Contraception
Efficacy and safety of a low-dose monophasic combination oral contraceptive containing 100 μg levonorgestrel and 20 μg ethinyl estradiol (Alesse®)
Am J Obstet Gynecol
A multicenter randomized comparison of cycle control and laboratory findings with oral contraceptive agents containing 100 μg levonorgestrel with 20 μg ethinyl estradiol or triphasic norethindrone with ethinyl estradiol
Am J Obstet Gynecol
Report of the Consensus Conference on Acne Classification. Washington, D.C., March 24 and 25, 1990
J Am Acad Dermatol
Serum androsterone conjugates differentiate between acne and hirsutism in hyperandrogenic women
Fertil Steril
Androgen sulfate and glucuronide conjugates in nonhirsute and hirsute women with polycystic ovarian syndrome
Am J Obstet Gynecol
Calculation of free and bound fractions of testosterone and estradiol-17β to human plasma proteins at body temperature
J Steroid Biochem
A randomized, controlled trial of 20 μg ethinyl estradiol/100 μg levonorgestrel for acne treatment
Fertil Steril
The effect of tetracycline on levels of oral contraceptives
Am J Obstet Gynecol
A study of interaction of low-dose combination oral contraceptive with ampicillin and metronidazole
Contraception
The lack of interaction between temafloxacin and combined oral contraceptive steroids
Contraception
Oral contraceptive failure rates and oral antibiotics
J Am Acad Dermatol
Oral contraceptives and bone mineral density: a population-based study
Am J Obstet Gynecol
Decreased bone turnover in oral contraceptive users
Bone
Prescribing and managing oral contraceptive pills and emergency contraception for adolescents
Pediatr Clin North Am
Oral contraceptive health benefits: perception versus reality
Contraception
Type of oral contraceptive in relation to acute, initial episodes of pelvic inflammatory disease
Contraception
Oral contraceptive type and functional ovarian cysts
Am J Obstet Gynecol
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2019, Journal of the American Academy of DermatologyCitation Excerpt :A fifth COC, ethinyl estradiol/cyproterone acetate (Diane-35; Berlex Canada, Pointe-Claire, Quebec, Canada), is used worldwide for acne (along with hirsutism and FPHL)43-45 but is not available in the United States because of its potential hepatotoxicity.42,46 Many clinical trials have demonstrated the efficacy of COCs in the reduction of inflammatory and noninflammatory acne in women.47-54 COCs can even improve acne in normoandrogenic women55 and should not be limited to individuals with established endocrine diagnoses.
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2015, Journal of the American Academy of DermatologyMeta-Analysis comparing efficacy of antibiotics versus oral contraceptives in acne vulgaris
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Funding sources: Wyeth Pharmaceuticals.
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Disclosure: Drs Leyden, Shalita, Hordinsky, Swinyer, and Stanczyk have received research grants from and/or have served as consultants for Wyeth Pharmaceuticals. Dr Margaret Weber is an employee of Wyeth Pharmaceuticals. Competing conflicts of interest are: Dr Leyden (Parke-Davis and Ortho-McNeil Pharmaceutical, Inc); Dr Shalita (Ortho-McNeil Pharmaceutical, Inc); Dr Hordinsky (Parke-Davis); Dr Swinyer (RW Johnson Pharmaceutical Research Institute and Parke-Davis); and Dr Stanczyk (none).
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Reprint requests: Margaret E. Weber, MD, Wyeth Pharmaceuticals, 150 Radnor-Chester Rd, St Davids, PA 19087.