LISBON – A novel, intradermally-injected, monophasic hyaluronic acid filler known as Belotero Intense outperformed Perlane for the treatment of moderate to deep nasolabial folds in a 12-month, double-blind, randomized trial, according to Dr. Martina Kerscher.
Merz Pharmaceuticals’ Belotero Intense is manufactured using a proprietary Cohesive Polydensified Matrix technology. The resultant product, a monophasic, polydensified hyaluronic acid filler, was designed to provide greater elasticity, less risk of lumping, and longer-lasting improvements than achievable with biphasic hyaluronic acid fillers, said Dr. Kerscher at the annual congress of the European Academy of Dermatology and Venereology.
She reported on 20 patients aged 35-65 years, with nasolabial folds (NLFs) that were grades 3-4 on a 5-point scale, meaning the defects were either moderately deep or very long and deep. Participants were randomized double-blindly to a single intradermal injection on one side of the face with Belotero Intense, while the NLFs on the other side of the face were treated with Medicis Aesthetics’ Perlane, a biphasic hyaluronic acid filler. Both products are gels of nonanimal origin. No touch-ups were permitted during the 12 months of follow-up.
Physician- and patient-rated scores on the Wrinkle Severity Rating Scale improved with both products; however, the degree of improvement was significantly greater through 24 weeks with the monophasic hyaluronic acid filler.
Belotero Intense is designed to provide greater elasticity, less risk of lumping, and longer-lasting improvements than is achievable with biphasic hyaluronic acid fillers, said Dr. Martina Kerscher.
Mean scores on the 0-4 scale went from a baseline of 4.0 to 2.4 with the biphasic filler and to 2.1 with the monophasic filler at week 2; at week 24, mean scores were 2.7 for the biphasic filler, compared with 2.4 for the monophasic filler. At week 48, however, both products showed similar effects.
Investigators and patients gave the monophasic hyaluronic acid gel higher marks on the Global Aesthetic Improvement Scale through 24 weeks. After week 24, scores for the two products merged, reported Dr. Kerscher of the University of Hamburg (Germany) division of cosmetic science.
Standardized measurements of wrinkle depth for the Belotero Intense-treated NLFs went from a baseline of 271 mm to 172 mm at week 2, 194 mm at week 24, and 213 mm at week 48. Depth of the Perlane-treated NLFs improved from 222 mm at baseline to 152 mm at week 2, 177 mm at week 24, and 184 mm at week 48. This translated to a 28% reduction in wrinkle depth at week 24 in the monophasic filler-treated lesions, compared with a 20% decrease in the biphasic filler-treated folds. The week 48 improvement was 21% in the monophasic- and 17% in the biphasic-treated NLFs.
Self-rated patient satisfaction was scored on a 0-10 scale, with a lower score showing a higher level of satisfaction. From a baseline of 7.0, scores improved to 2.3 for the biphasic filler and 2.1 for the monophasic filler at week 2, to 4.9 for biphasic and 3.8 for monophasic at week 24, and to 6.7 for biphasic and 5.7 for monophasic at week 48.
Of note, the blinded patients consistently recorded significantly less injection site pain with the monophasic hyaluronic acid filler.
Belotero Intense is licensed in the United Kingdom and several European countries as a medical device for the correction of deep folds and for volume augmentation. A sister product, Belotero Balance, earned marketing approval from the Food and Drug Administration in November 2011 for correction of moderate to severe wrinkles and folds. Belotero Intense is intended for deeper injection and correction of more pronounced defects than is Belotero Balance.
Merz is seeking FDA approval of Belotero Intense.
The study presented by Dr. Kerscher was sponsored by Merz, which markets the Belotero product line. She is a consultant to the company.