SEOUL, SOUTH KOREA — The hyaluronic acid filler Voluma demonstrated excellent efficacy, durability, and patient satisfaction in correcting midface volume deficits at the interim 78-week analysis in a large prospective multicenter study.
At 78 weeks, 84% of patients maintained a clinically meaningful improvement after a single baseline injection and a touch-up injection, if needed, at week 4, Dr. Greg J. Goodman said at the World Congress of Dermatology.
Moreover, 95% of participants pronounced themselves satisfied or very satisfied with the product at the 78-week mark. An equal percentage indicated they would recommend the treatment to others, added Dr. Goodman of Monash University, Melbourne.
Based upon these interim results of what will be a 104-week study – the first-ever formal study of the filler’s long-term effects in daily clinical practice – correction of mild to severe midface volume deficits with Voluma is a safe, effective, long-lasting, and cost-effective alternative to surgical correction, he continued.
The study involved 103 middle-aged subjects with a baseline score of 2-5 on the 6-point Mid-Face Volume-Deficit Scale (MVDS). They were corrected to a 0 or 1, meaning no or mild deficit, by means of a baseline injection of up to 2 cc of Voluma per side. This was followed by an additional injection of up to 2 cc per side if needed at week 4. Patients received a mean total volume of 3.1 mL per side. No further retreatment was permitted until week 78.
A greater than 1-point improvement over baseline MVDS was present in 96% of patients at week 8, 90% at week 52, and 84% at week 78. Similarly, 100% of patients had a greater than 1-point improvement on the 5-point Global Aesthetic Improvement Scale (GAIS)at week 8, 92% at week 52, and 82% at week 78. In all, 78% of patients rated themselves as having more than a 1-point improvement on the GAIS at week 78.
At week 78, 32% of patients received a supplemental injection of Voluma, based upon protocol-defined criteria indicating they had returned to within less than 1 MVDS point of their pretreatment midface volume.
The chief side effect of treatment was mild to moderate bruising at the injection site. This was much more common early in the study, when Voluma was new to Australian physicians.
"We were finding our way back then," Dr. Goodman recalled.
The study was sponsored by Allergan. Dr. Goodman is a consultant to the company.