AT THE ODAC CONFERENCE
ORLANDO (FRONTLINE MEDICAL NEWS) – A non-resorbable wrinkle filler proved highly effective and durable for the treatment of atrophic acne scars in a randomized, controlled, multicenter study.
At 1 month after treatment with polymethylmethacrylate-collagen, or PMMA-collagen (Artefill, Suneva Medical, Inc.), nearly 70% of 97 subjects showed at least a 2-point improvement on the validated 4-point Acne Scar Rating Scale, compared with about 40% of 50 control subjects injected with saline. At 6 months, the response rate remained above 60% in the PMMA-collagen group, but dropped closer to 30% among those in the control group, Dr. James M. Spencer of Mount Sinai School of Medicine, New York reported in a poster at the Orlando Dermatology Aesthetic and Clinical Conference.
The control group subjects were then crossed over to the treatment group, and, at 12 months, the response rates were about 70% and nearly 60% in the treatment and control groups, respectively, he said.
Similarly, both Physician and Subject Global Aesthetic Improvement Scale (PGAIS/SGAIS) scores diverged during a 6-month evaluator-blinded phase of the study, then converged after crossover by the control group subjects. For example, the percentage of treatment and control group subjects with improvement at 1 month and 6 months according to the 5-point PGAIS was about 90% vs. less than 65%, and about 80% vs. about 30%, respectively. More than 90% in both groups showed improvement at 12 months, after control group crossover.
Additionally, subject satisfaction at 1 and 6 months in the treatment and control groups based on assessment of scar correction using Patient Satisfaction Scale scores was above 80% vs. about 60%, and about 80% vs. about 50%, respectively. Satisfaction in both groups was between 80% and 90% at 12 months, after control group crossover.
Study subjects, who had a mean age of 44 years, were enrolled from 10 U.S. centers and were treated during one injection session. An additional touch-up injection was allowed as needed. A total of 1,292 scars were treated in the 97 treatment group subjects, and 424 were treated in the 50 control group subjects. Participants were evaluated by blinded assessors at 2 weeks and 1, 3, and 6 months, after which control group subjects were treated with PMMA-collagen. Assessments were made in open-label fashion at 9 and 12 months. Most subjects (61%) were women, and 20% had Fitzpatrick skin types 5 or 6.
During the blinded portion of the study, six treatment-related adverse events were reported among treatment group subjects, and two were reported among control group subjects. None of the subjects experienced granulomas, changes in pigmentation, or hypertrophic scarring.
This study is the first randomized, blinded study of PMMA-collagen for treating acne scars, Dr. Spencer noted, adding that the findings demonstrate the efficacy and safety of PMMA-collagen for this purpose.
“The improvement is durable, lasting for 12 months,” he wrote, noting that the filler is easily administered and requires minimal training in those who are familiar with dermal fillers.
“PMMA-collagen works very well on deep, severe acne scars, and should also work very well on shallow scars,” he said.
The product may enable practitioners to effectively treat acne scarring without a large capital equipment expenditure and without the risks associated with resurfacing procedures,” he said.
This study was sponsored by Suneva Medical, Inc.