ORLANDO – An over-the-counter 5.5% benzoyl peroxide preparation with lipohydroxy acid was a safe and effective alternative to prescription 5% benzoyl peroxide with 1% clindamycin in a 12-week randomized, double-blind, multicenter study of patients with mild to moderate acne vulgaris who also were treated with generic 0.025% tretinoin.
Statistically significant improvement on a variety of efficacy endpoints was seen at weeks 8 and 12 in 60 men and women aged 18-50 years who were randomized to either the OTC-based or prescription-based regimen, Susana Raab of L’Oreal Research & Innovation, Clark, N.J., reported in a poster at the Orlando Dermatology Aesthetic and Clinical Conference.
Courtesy Wikimedia Commons/Kinan Ayu/Creative Commons license
The mean reduction in total acne lesion count at week 8 was approximately 60% with the OTC regimen and 64% in the prescription regimen. At week 12, the mean reduction was about 72% in both groups. The mean improvement in global acne assessment was approximately 31% and 33% in the groups, respectively, at 8 weeks, and about 33% in both groups at 12 weeks.
The mean improvement in overall appearance was 37%-38% in both groups at 8 weeks, and was close to 50% in both groups at 12 weeks, Ms. Raab said.
All skin types and a range of ethnicities were represented in the study population. Subjects applied the OTC benzoyl peroxide with lipohydroxy acid or the prescription benzoyl peroxide and clindamycin twice daily for 12 weeks. The tretinoin was applied daily at night after the other products were dried and absorbed. Three blinded board-certified dermatologists assessed the subjects for tolerability, and lesion counts were performed on the entire face to assess for open and closed comedones, papules, and pustules.
The dermatologists also assessed for tone, smoothness, brightness, appearance of pores, global acne, overall skin appearance, and tolerability.
The degree of acne relapse was assessed during a 4-week regression phase at which time the treatment was discontinued.
Both treatments improved inflammatory and noninflammatory lesions to a similar degree within 2 weeks of use. Dryness and peeling were seen with both treatments, but resolved by week 12. Stinging, tingling, itching, and burning also were common with both treatments, and largely resolved in both groups by week 8, except for significant stinging in the OTC treatment group. No significant overall differences were seen between the groups with respect to tolerance parameters, Ms. Raab noted.
“When compared, both treatments were at parity in improvement of all efficacy attributes at all time points,” she and her colleagues concluded.