Journal of the American Academy of Dermatology
Effectiveness of norgestimate and ethinyl estradiol in treating moderate acne vulgaris☆,☆☆,★
Section snippets
Study design
This prospective study was conducted from November 1993 through May 1995 at 10 investigational centers in the United States. This was one of two studies designed to evaluate the efficacy of the triphasic norgestimate/ethinyl estradiol OC in the treatment of acne vulgaris. These studies were double blind, randomized, and placebo controlled, with appropriate, statistically determined sample sizes. Results of the other study have been published elsewhere. 13 The study was conducted in compliance
Data set analyzed
The safety analyses included 231 subjects and were performed on all subjects who took study medication and had at least one on-study safety assessment, but not necessarily an efficacy assessment. Two hundred twenty-eight subjects were included in the intent-to-treat data set (all subjects who received study medication and had at least one on-therapy efficacy evaluation), and 160 subjects were included in the evaluable-for-efficacy data set (all subjects who completed the study with no major
DISCUSSION
Although other studies of the effect of OCs on acne have been performed, they were less comprehensive than this trial. By failing to include a placebo control group, earlier studies neglected to account for the large placebo effect that is typical of acne studies. 14, 15, 16, 17, 18, 19, 20 Placebo effects in acne studies are caused in part by the regression to the mean phenomenon as well as the inclusion of careful skin care. In addition, participants are usually seen regularly by their
Acknowledgements
We wish to acknowledge the participation of the ORTHO TRI-CYCLEN Acne Vulgaris Study Group II: D. Baker, Portland, Ore.; J. Barkoff, Albuquerque, N.M.; T. Jones, Bryan, Tex.; M. Kanzler and D. Gorsulowsky, Fremont, Calif.; M. Lebwohl, New York, N.Y.; J. Lindholm and H. Katz, Fridley, Minn.; A. Lucky, Cincinnati, Ohio; D. Pariser and R. Pariser, Norfolk, Va.; G. Redmond, Cleveland, Ohio; and L. Swinyer, Salt Lake City, Utah.
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Cited by (0)
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Supported by Ortho-McNeil Pharmaceutical, Raritan, N.J.
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Reprint requests: Anne W. Lucky, MD, Dermatology Research Associates, Inc., 7691 Five Mile Rd., Suite 312, Cincinnati, OH 45230.
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