Secondary end points are summarized in Table 4. The percent of patients with
a 2-grade improvement in IGA was 23.3% for vehicle-treated patients compared to
37.5%, and 56.7 % for the 1% and 5% active groups, respectively. No changes in persistent erythema or telangiectasias were found.
Perilesional erythema was decreased with the decrease in lesions.
All three formulations were well tolerated. Few subjects had moderate local
application site irritation (dryness, scaling, pruritus, stinging, and burning) post-baseline.
No subjects had severe dryness, scaling, or pruritus post-baseline. No subjects who applied Vehicle Gel or 1% E-BPO Gel had severe stinging or burning post-baseline.
One subject who applied 5% E-BPO Gel had severe stinging and burning that was reported as an AE.
DISCUSSION
In this study, we found E-BPO to be effective in reducing the number of inflammatory
lesion in patients with PPR. There was a clear trend of a dose response with the IGA success
of 20% for the vehicle and 37% and 53% for the 1% and the 5% formulations, respectively.
The reduction in inflammatory lesions also showed a trend towards a dose response.
Since benzoyl peroxide has no known anti-inflammatory properties but is a potent antimicrobial agent,
these results suggest a microbial factor as the stimulus or trigger for the follicular inflammation of PPR.
Benzoyl peroxide is a difficult agent to do M.I.C. determinations because of its poor solubility in
aqueous systems and no studies exist regarding the susceptibility of
Demodex Folliculorum to this drug. The other follicular organism, Propionibacterium
