MIAMI BEACH – It may now be possible for patients to experience the benefits of hyaluronic acid fillers without a needle, according to investigators.
In a double-blind, controlled study of 100 women with moderate to severe photo-damaged skin, a novel nanotechnology was used to shepherd topical hyaluronic acid through the dermis, essentially overcoming the large particle size hurdle of years past.
Dr. Glynis Ablon
Significant improvements in overall efficacy, skin roughness, and "smoothing effect" were observed after 90 days. Blinded observers reported the benefits in 40 women who applied topical cross-linked hyaluronic acid (Restylane) twice a day to their full face, compared with 20 women who applied the nanotechnology vehicle only. Additional significant improvements were seen among another 40 women who applied non-cross linked topical hyaluronic acid using the same regimen.
"We know the skin is a barrier. It acts as a barrier for things getting in, but it can also prevent topical compounds from getting in," said Dr. Glynis R. Ablon, who is on the dermatology faculty at the University of California, Los Angeles.
"Topical hyaluronic acid does appear to be penetrating the skin with this unique Ionic Nano Particle Technology [INParT] delivery system," she said.
The potential for Transdermal Corp’s INParT extends beyond patients with photo-damaged skin and could provide additional therapeutic options for acne, rosacea, psoriasis, and melasma, said Dr. Ablon, at the South Beach Symposium.
Dr. Ablon and her colleague Dr. Mark S. Nestor conducted the study at two U.S. sites. Participants were 35 to 65 years old and evaluated at days 15, 45, 90, and 120 (following a 4-week washout period).
They assessed six parameters. For example, at 120 days, the percentage of patients with skin roughness rated as "smooth" or "very smooth" was 100% of the cross linked group, 88% of the non-cross linked group, and 55% of controls. Similarly, at 20 weeks skin ratings of "hydrated" or "very hydrated" were reported for 100% of the cross-linked group, 87% of the non-cross linked group, and 52% of controls.
Similar improvements in skin elasticity, skin radiance, and "smoothing effect" were also observed.
The raters also measured overall efficacy at the same time point. The percentage of patients who reported good or excellent overall efficacy was 93% in the cross-linked group, 35% in the non-cross linked group, and 0% in the control group.
Topical hyaluronic acid "appears to have a significant aesthetic enhancement effect," Dr. Ablon said.
Interestingly, skin roughness, hydration, and elasticity ratings continued to improve even after 90 days in the cross-linked hyaluronic acid group, Dr. Ablon said. This finding suggests collagen remodeling took place.
The researchers also assessed how well participants accepted the therapy at 12 weeks. "Tolerance was 100% across the board," Dr. Ablon said.
Transdermal Corp funded this study through an unrestricted educational grant. Dr. Ablon and Dr. Nestor are consultants and investigators for Transdermal Corp. Dr. Ablon also is an investigator and advisory board member for Medicis, which markets Restylane. Dr. Nestor is an investigator, consultant, speaker, and advisory board member for Medicis.