In the various placebo-controlled clinical trials, the most common adverse events associated with oral prasterone (200mg) were acne and hirsutism. These are both apparently secondary to androgenic activity of prasterone or its metabolites.
In the placebo-controlled trials, acne was frequently cited as a reason for early discontinuation. Acne was not, however, reported as severe. It diminishes with the use of common topical non-prescription anti-acne treatments.[i]
Based on time to first report of the event, the frequency of patients reporting acne declines after the first 6 months.
In the pooled data for the United States placebo-controlled trials, acne was reported in greater than 35% of patients in the prasterone groups, compared to approximately 15% of placebo patients. In a Taiwan clinical trial, acne was reported in almost 60% of patients in the prasterone group, compared to almost 30% of placebo patients. The higher rate of acne in the Taiwan clinical trial may be due to the fact that in the Taiwan clinical trial, the proportion of patients receiving concomitant corticosteroids was much higher than in the United States clinical trials.
The occurrence of acne is not dose-related, nor related to the patient