IncobotulinumtoxinA for the treatment of platysmal bands: a single-arm, prospective proof-of-concept clinical study.

BACKGROUND: IncobotulinumtoxinA improves the appearance of facial rhytides and the aging neck. OBJECTIVE: To investigate the efficacy, safety, and subject satisfaction of incobotulinumtoxinA for platysmal band treatment. METHODS: Subjects (n = 23) with 2 to 4 platysmal bands (scoring ≥1 on a newly validated 5-point assessment scale) were enrolled. IncobotulinumtoxinA (15 U) was administered to each band. Assessments, using the 5-point scale, occurred at 6 posttreatment visits over 5 months. Adverse events were recorded and subjects self-assessed the appearance of their platysmal bands versus baseline. RESULTS: At maximum tension, a response (≥1-point improvement from baseline score) was observed in 65.2% of subjects 3 (±1) days posttreatment, rising to 100% on Day 8 (±1). The change from baseline in the mean score was significant at each time point, including the final visit (Weeks 20-21). Response rates were higher at maximum tension than at rest. The peak effect occurred later at rest than at maximum tension. No serious adverse event occurred. At maximum tension, 69.6%, 73.9%, and 68.2% of subjects rated their platysmal bands as "improved" or "markedly improved" at Visits 2, 3, and 4, respectively. CONCLUSION: IncobotulinumtoxinA is an effective and well-tolerated treatment for platysmal bands, with a rapid onset and long duration of effect.

Onset, longevity, and patient satisfaction with incobotulinumtoxinA for the treatment of glabellar frown lines: a single-arm, prospective clinical study.

BACKGROUND: IncobotulinumtoxinA (Bocouture(®)) is free from complexing proteins and effective for treating glabellar frown lines. PURPOSE: To determine the efficacy, onset, and duration of action of incobotulinumtoxinA for the treatment of glabellar frown lines. PATIENTS AND METHODS: In this single-arm, prospective, proof-of-concept study, 23 patients were treated with 25 U incobotulinumtoxinA, equally split between five injection sites in the glabella. Severity of glabellar frown lines was rated by an independent rater from standardized photographs using the validated Merz 5-point scale at several visits over 5 months following treatment. To assess patient satisfaction, patients completed a questionnaire before and 2 weeks after treatment. RESULTS: The percentage of responders at maximum frown 2-4 days after treatment was 95.2% and 85.0% when responders were defined as patients with ≥ 1-point and ≥ 2-point improvement on the 5-point scale compared with baseline, respectively. At this time point, 84% of the maximum effect had occurred. The responder rate at maximum frown, according to both definitions, was 100% for at least the next two visits (days 8 ± 1 and 14 ± 2). At all visits, the change from baseline in the mean glabellar frown-line score at maximum frown was statistically significant, with on average an almost 1-point improvement from baseline 5 months after treatment. CONCLUSION: IncobotulinumtoxinA is an effective and well-tolerated treatment for glabellar frown lines, with a rapid onset of action and a long duration of effect lasting for more than 5 months.

A prospective, split-face, randomized, comparative study of safety and 12-month longevity of three formulations of hyaluronic acid dermal filler for treatment of nasolabial folds.

BACKGROUND: Data regarding several hyaluronic acids (HAs) used identically for facial tissue augmentation have heretofore been unavailable. OBJECTIVES: This prospective, split-face, randomized, two-armed study sought to determine the long-term safety and effectiveness of three HAs (HA-1 (Belotero Basic/Balance), HA-2 (Restylane), and HA-3 (Juvéderm Ultra 3/Juvéderm Ultra Plus XC) in the treatment of nasolabial folds (NLFs). METHODS: Twenty participants in Arm A received HA-1 in one NLF and HA-2 in the other. In Arm B, 20 participants received HA-1 in one NLF and HA-3 in the other. Injection was at visit 2, with follow-up visits at 1, 6, 9, and 12 months. Mean volume of HA was slightly <1.5 mL/NLF. RESULTS: Adverse events were unremarkable across all HAs, with injection site erythema being the most frequent adverse event. Mean pretreatment NLF severity rating for both arms was 2.3; at 12 months, mean posttreatment severity rating was 1.5 for HA-1/HA-2 and 1.6 for HA-1/HA-3. Although not statistically significant, participants tended to show a preference for HA-1. CONCLUSION: All three HAs provided essentially equivalent results, except for 4-week evenness results, which favored HA-1. Injection volumes of the three HAs were also similar.

Noninferiority of incobotulinumtoxinA, free from complexing proteins, compared with another botulinum toxin type A in the treatment of glabellar frown lines.

BACKGROUND: Use of botulinum toxin for esthetic purposes has rapidly expanded over the last 20 years. IncobotulinumtoxinA, also known as NT 201, is a new botulinum toxin type A (150 kDa) that is free from complexing proteins. OBJECTIVES: A prospective, multicenter, randomized, rater- and patient-blind, international Phase III trial to investigate the noninferiority of incobotulinumtoxinA to another botulinum toxin type A, onabotulinumtoxinA, in the treatment of glabellar frown lines. METHODS: A total of 381 patients were randomized in a 3:1 (incobotulinumtoxinA:onabotulinumtoxinA) ratio to receive 24 U incobotulinumtoxinA of or onabotulinumtoxinA. Efficacy end points included the percentage of responders (patients with an improvement of ≥1 point on a 4-point facial wrinkle scale) at maximum frown at weeks 4 and 12 as assessed by the investigators, and a panel of independent raters based on standardized digital photographs. RESULTS: Four weeks after injection, response rates at maximum frown were 96.4% in the incobotulinumtoxinA group and 95.7% in the onabotulinumtoxinA group as assessed by independent raters. Analysis of the data confirmed the noninferiority of incobotulinumtoxinA. Response rates at rest were lower for both products. The rate of adverse events was low. CONCLUSION: IncobotulinumtoxinA is equally as effective as onabotulinumtoxinA in the treatment of glabellar frown lines. Both preparations were well tolerated.