Randomized split-face study using a post-procedural biotech cellulose mask to improve patient comfort and downtime.

BACKGROUND: There are many post-procedural treatments touted to improve comfort and decrease downtime, but very few prospective randomized studies. AIMS: To analyze the safety and efficacy of a post-procedural biotech cellulose mask. PATIENTS/METHOD: Fifteen patients undergoing either a microneedling with radiofrequency (n = 5), non-ablative fractional (n = 5), or full erbium:YAG resurfacing (n = 5) treatment were randomized to receive a biotech cellulose mask on one side of the face for 30 min after the procedure and for 2 h a day until healed. Standardized photos and thermal images were taken 30 min after the procedure and daily until healed. The investigator and blind evaluators reviewed the photos, and subjects answered daily questionnaires. RESULTS: An analysis of the thermal images showed a significant reduction in facial temperature on the biotech cellulose mask side as compared to the control side in all groups with an average of 2.2 (range 0.2-6.5) degree Celsius reduction across all 15 subjects. All subjects reported less pain and heat immediately upon application of the mask. Thirty minutes after application, 13/15 continued to report less pain and heat, and 11/15 reported less erythema and swelling on the mask side while blind evaluators were able to choose which side had the mask 80% of the time. On average, subjects also reported significantly less swelling on Day 1 and Day 2. CONCLUSION: The biotech cellulose mask decreased patient's facial temperature, feelings of heat and pain, as well as downtime without any side effects for the subjects in this study undergoing a variety of treatments.

One-Year Data on the Longevity and Safety of Hyaluronic Acid Filler for Static Horizontal Neck Rhytids.

BACKGROUND: The long-term efficacy and safety of hyaluronic acid fillers injected into the neck have yet to be analyzed in a prospective trial in the United States. OBJECTIVE: Analyze the long-term efficacy and safety of a hyaluronic acid filler for static horizontal neck rhytids. MATERIALS AND METHODS: Twenty-six subjects were enrolled in the study. Six subjects were randomized to receive saline and 20 subjects were randomized to receive HA RR. All subjects were randomized to use a cannula on 1 side and needle on the other with optional retreatment on day 30 and optional crossover treatment with different assignment on day 60. The subjects were graded using the Transverse Neck Line Scale, Canfield photography, and the Global Aesthetic Improvement Scale on day 360. RESULTS: A significant improvement from baseline on day 360 was achieved on the Transverse Neck Line Scale according to the blind evaluator, subjects, and investigator without any delayed-onset or prolonged side effects. There was no significant difference in the average improvement from the short-term analysis on day 60 to the long-term analysis on day 360. CONCLUSION: HA RR achieved significant long-term improvement in static horizontal neck rhytids without any long-term side effects.

A split-face, blind, randomized placebo-controlled clinical trial investigating the efficacy and safety of hyaluronic acid filler for the correction of atrophic facial scars.

BACKGROUND: Hyaluronic acid fillers have been studied extensively for facial wrinkles; however, their efficacy for atrophic facial scars has yet to be analyzed in a prospective placebo-controlled study. OBJECTIVE: To analyze the efficacy and safety of a hyaluronic acid filler for atrophic facial scars. METHODS & MATERIALS: Fifteen subjects were randomized to receive up to 1 ml of VYC-17.5 L on one cheek and up to 1 ml of saline on the other side, with an optional touch-up treatment. Subjects were graded by a live blind evaluator using the Quantitative Global Scarring Grading System (QGSGS) (J Cosmet Dermatol. 2006;5:48), the Global Aesthetic Improvement Scale (GAIS), and Canfield photo-analysis. RESULTS: According to the blind evaluator, there was a significant reduction 90 days after the last treatment on the QGSGS for VYC-17.5L compared with saline (-6.6 VYC-17.5L vs -1.7 saline [t(28) = -4.3196, p = 0.008]). There was a smaller, but still significant reduction on the QGSGS for saline alone (10.4 to 8.6 [t(14) = -3.453, p = 0.004]). In addition, 93% (13/14) of subjects chose VYC-17.5L over saline treatment and reported an improvement on the GAIS. There were no serious side effects and all minor side effects resolved by Day 30. CONCLUSION: VYC-17.5L achieved significant improvements in rolling atrophic scars as compared to saline, though saline also had modest improvements.

A Randomized, Placebo-Controlled, Split-Neck Trial of Hyaluronic Acid Filler for Static Horizontal Neck Rhytides Using Either a Cannula or Needle.

BACKGROUND: Hyaluronic acid (HA) fillers have been studied extensively on the face; however, their safety and efficacy on the neck has not yet been evaluated in a prospective trial in the United States. OBJECTIVE: Analyze the efficacy and safety of a HA filler for static horizontal neck rhytides using either a cannula or needle. MATERIALS AND METHODS: Twenty-six subjects were randomized to receive up to 1 mL of the HA filler Restylane Refyne (HARR, n = 20) or saline (n = 6) using a cannula on one side and a needle on the other with optional repeat treatment. Subjects were graded using the Transverse Neck Line Scale, Canfield photography, and the Global Aesthetic Improvement Scale. RESULTS: A significant improvement 30 days after the last treatment was achieved on the Transverse Neck Line Scale when comparing HARR with saline according to the blind evaluator, subjects, and investigator without any significant side effects. In addition, the blind evaluator, subjects, and investigator rated the side of the neck injected with a needle as having significantly greater improvement than the cannula. CONCLUSION: The hyaluronic acid filler, Restylane Refyne, achieved significant improvement in static horizontal neck rhytides using either a cannula or needle without any serious side effects, although the needle was more effective.