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Norgestimate and ethinyl estradiol in the treatment of acne vulgaris: a randomized, placebo-controlled trial.
Obstet Gynecol. 1997 Apr; 89(4):615-22.OG

Abstract

OBJECTIVE

To evaluate the efficacy of a triphasic, combination oral contraceptive (OC), (norgestimate-ethinyl estradiol), in comparison with placebo in the treatment of moderate acne vulgaris.

METHODS

Two hundred fifty women were enrolled in a multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the effectiveness of norgestimate-ethinyl estradiol in the treatment of acne vulgaris. Subjects were 15-49 years old and had moderate acne vulgaris. Each month for 6 months, subjects received either 3 consecutive weeks of active OC treatment followed by 1 week of inactive drug, or 4 consecutive weeks of color-matched placebo tablets. Efficacy was assessed by facial acne lesion counts, the investigator's global assessment, and the subject's self-assessment. Hormone levels were also measured.

RESULTS

Despite the large placebo effect inherent in an acne trial (due to, for example, careful skin care, frequent office visits, regression to the mean), of the 164 subjects who completed the study without major protocol deviations, the OC group was significantly better than the placebo group for all primary efficacy measures: inflammatory lesions (mean reduction, 51.4% compared to 34.6%; P = .01), total lesions (mean reduction, 46.4% compared to 33.9%; P = .001); investigator's global assessment (83.3% compared to 62.5%; P = .001). Free testosterone decreased significantly and sex hormone-binding globulin increased significantly in the OC group, but remained unchanged in the placebo group.

CONCLUSION

A triphasic combination of norgestimate and ethinyl estradiol is an effective treatment for moderate acne vulgaris in women with no known contraindication to OC therapy.

Authors+Show Affiliations

Foundation for Developmental Endocrinology, Inc., Cleveland, Ohio, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

9083323

Citation

Redmond, G P., et al. "Norgestimate and Ethinyl Estradiol in the Treatment of Acne Vulgaris: a Randomized, Placebo-controlled Trial." Obstetrics and Gynecology, vol. 89, no. 4, 1997, pp. 615-22.
Redmond GP, Olson WH, Lippman JS, et al. Norgestimate and ethinyl estradiol in the treatment of acne vulgaris: a randomized, placebo-controlled trial. Obstet Gynecol. 1997;89(4):615-22.
Redmond, G. P., Olson, W. H., Lippman, J. S., Kafrissen, M. E., Jones, T. M., & Jorizzo, J. L. (1997). Norgestimate and ethinyl estradiol in the treatment of acne vulgaris: a randomized, placebo-controlled trial. Obstetrics and Gynecology, 89(4), 615-22.
Redmond GP, et al. Norgestimate and Ethinyl Estradiol in the Treatment of Acne Vulgaris: a Randomized, Placebo-controlled Trial. Obstet Gynecol. 1997;89(4):615-22. PubMed PMID: 9083323.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Norgestimate and ethinyl estradiol in the treatment of acne vulgaris: a randomized, placebo-controlled trial. AU - Redmond,G P, AU - Olson,W H, AU - Lippman,J S, AU - Kafrissen,M E, AU - Jones,T M, AU - Jorizzo,J L, PY - 1997/4/1/pubmed PY - 1997/4/1/medline PY - 1997/4/1/entrez SP - 615 EP - 22 JF - Obstetrics and gynecology JO - Obstet Gynecol VL - 89 IS - 4 N2 - OBJECTIVE: To evaluate the efficacy of a triphasic, combination oral contraceptive (OC), (norgestimate-ethinyl estradiol), in comparison with placebo in the treatment of moderate acne vulgaris. METHODS: Two hundred fifty women were enrolled in a multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the effectiveness of norgestimate-ethinyl estradiol in the treatment of acne vulgaris. Subjects were 15-49 years old and had moderate acne vulgaris. Each month for 6 months, subjects received either 3 consecutive weeks of active OC treatment followed by 1 week of inactive drug, or 4 consecutive weeks of color-matched placebo tablets. Efficacy was assessed by facial acne lesion counts, the investigator's global assessment, and the subject's self-assessment. Hormone levels were also measured. RESULTS: Despite the large placebo effect inherent in an acne trial (due to, for example, careful skin care, frequent office visits, regression to the mean), of the 164 subjects who completed the study without major protocol deviations, the OC group was significantly better than the placebo group for all primary efficacy measures: inflammatory lesions (mean reduction, 51.4% compared to 34.6%; P = .01), total lesions (mean reduction, 46.4% compared to 33.9%; P = .001); investigator's global assessment (83.3% compared to 62.5%; P = .001). Free testosterone decreased significantly and sex hormone-binding globulin increased significantly in the OC group, but remained unchanged in the placebo group. CONCLUSION: A triphasic combination of norgestimate and ethinyl estradiol is an effective treatment for moderate acne vulgaris in women with no known contraindication to OC therapy. SN - 0029-7844 UR - https://www.unboundmedicine.com/medline/citation/9083323/Norgestimate_and_ethinyl_estradiol_in_the_treatment_of_acne_vulgaris:_a_randomized_placebo_controlled_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0029-7844(97)00059-8 DB - PRIME DP - Unbound Medicine ER -