Brief reportA systemic type i 5 α-reductase inhibitor is ineffective in the treatment of acne vulgaris☆
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Test agent, dosage selection, and duration of trial
Compound A is a selective and potent inhibitor of type I 5 α-reductase. Data from healthy volunteers demonstrated dose-dependent decreases in serum and sebum DHT levels at doses ranging from 5 to 25 mg/d.10 Pharmacokinetic studies of doses above 25 mg/d were nonlinear and did not result in a significant increase in plasma area under the curve. For these reasons 25 mg/d was the chosen test dose. In a pilot study for patients with mild to moderately severe acne, 25 mg/d produced a significant
Results
A total of 182 evaluable patients received 3 months of therapy. In all, 37 received 3 months of therapy with Compound A, 34 received 100 mg of minocycline twice a day, 74 received a combination of minocycline (100 mg twice a day) and 25 mg of Compound A daily, and 37 were treated with placebo. Table II, Table III Between group difference Difference 95% Confidence intervals P value Compound A (25 mg) vs placebo −0.4 −5.3,4.4 .862 Compound A (25 mg) vs minocycline 5.1 0.2, 10.0 .045 Compound A (25 mg) vs
Discussion
In this trial, a potent and selective type I 5 α-reductase inhibitor was not significantly different from placebo in the treatment of moderately severe inflammatory acne. Significant improvement was seen in those treated with minocycline (100 mg twice a day) and those treated with the combination of this antibiotic and the type I 5 α-reductase inhibitor. However, no increment in improvement was seen for patients treated with the combination. These negative results raise important questions
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Supported by Merck Research Laboratories.
Disclosure: Several authors have consultancy agreements with, are members of the Speakers Bureau at, or are employees of the sponsoring company.