90768
document
Effectiveness of norgestimate and ethinyl estradiol in treating moderate acne vulgaris . BACKGROUND An excess of androgen is believed to contribute to development of acne in some patients . Because oral contraceptives ( OCs ) may reduce the active androgen level , hormonal therapy with OCs has been used successfully to treat patients with acne , although this treatment has previously not been studied in placebo-controlled trials . OBJECTIVE Our purpose was to evaluate the efficacy of a triphasic , combination OC ( ORTHO TRI-CYCLEN [ Ortho-McNeil Pharmaceutical , Raritan , N.J. ] , norgestimate/ethinyl estradiol ) compared with placebo in the treatment of moderate acne vulgaris . METHODS Two hundred fifty-seven healthy female subjects , 15 to 49 years of age with moderate acne vulgaris , were enrolled in a multicenter , randomized , double-blind , placebo-controlled clinical trial . Each month for 6 months , subjects received either 3 consecutive weeks of the OC ( i.e. , tablets containing a fixed dose of ethinyl estradiol [ 0.035 mg ] and increasing doses of norgestimate [ 0.180 mg , 0.215 mg , 0.250 mg ] ) followed by 7 days of inactive drug or placebo ( color-matched tablets ) . Efficacy was assessed by facial acne lesion counts , an investigator 's global assessment , a subject 's self-assessment , and an analysis of within-cycle variation ( cycle 6 ) in lesion counts . RESULTS Of the 160 subjects in whom efficacy could be evaluated , the OC group showed a statistically significantly greater improvement than the placebo group for all primary efficacy measures . The mean decrease in inflammatory lesion count from baseline to cycle 6 was 11.8 ( 62.0 % ) versus 7.6 ( 38.6 % ) ( p = 0.0001 ) , and the mean decrease in total lesion count was 29.1 ( 53.1 % ) versus 14.1 ( 26.8 % ) ( p = 0.0001 ) in the OC and placebo groups , respectively . In the investigator 's global assessment , 93.7 % of the active treatment group versus 65.4 % of the placebo group were rated as improved at the end of the study ( p < 0.001 ) . Six of the seven secondary efficacy measures ( total comedones , open comedones , closed comedones , papules , pustules , and the subject 's self-assessment of study treatment ) were also significantly more favorable in the OC group compared with the placebo group . CONCLUSION An OC containing 0.035 mg of ethinyl estradiol combined with the triphasic regimen of norgestimate is a safe and effective treatment of moderate acne vulgaris in women with no known contraindication to OC therapy .
90769
Intervention_Pharmacological
norgestimate
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Intervention_Pharmacological
ethinyl estradiol
90771
Intervention_Pharmacological
oral contraceptives
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Intervention_Pharmacological
triphasic , combination OC
90773
Intervention_Pharmacological
ORTHO TRI-CYCLEN
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Intervention_Pharmacological
Ortho-McNeil Pharmaceutical
90775
Intervention_Pharmacological
Raritan
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Intervention_Pharmacological
norgestimate/ethinyl estradiol )
90777
Intervention_Control
placebo
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Intervention_Pharmacological
OC
90779
Intervention_Pharmacological
ethinyl estradiol
90780
Intervention_Pharmacological
norgestimate
90781
Intervention_Pharmacological
inactive drug
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Intervention_Control
placebo
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Intervention_Pharmacological
ethinyl estradiol
90784
Outcome_Other
Effectiveness
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Outcome_Other
efficacy
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Outcome_Other
Efficacy
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Outcome_Physical
facial acne lesion counts
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Outcome_Physical
global assessment
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Outcome_Other
subject 's self-assessment
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Outcome_Physical
within-cycle variation ( cycle 6 ) in lesion counts .
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Outcome_Physical
improvement
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Outcome_Physical
mean decrease in inflammatory lesion count
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Outcome_Physical
mean decrease in total lesion count
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Outcome_Physical
investigator 's global assessment
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Outcome_Physical
secondary efficacy measures ( total comedones , open comedones , closed comedones , papules , pustules , and the subject 's self-assessment of study treatment )
90796
Outcome_Other
safe and effective treatment of moderate acne vulgaris
90797
Participant_Condition
moderate acne vulgaris
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Participant_Condition
acne
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Participant_Sample-size
Two hundred fifty-seven
90800
Participant_Condition
healthy
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Participant_Sex
female
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Participant_Age
15 to 49 years of age
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Participant_Condition
moderate acne vulgaris
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Participant_Sample-size
160
90805
Participant_Sex
women