IncobotulinumtoxinA versus onabotulinumtoxinA in the treatment of glabellar facial lines: results from a multicenter, randomized, double-blinded trial

IncobotulinumtoxinA versus onabotulinumtoxinA in the treatment of glabellar facial lines: results from a multicenter, randomized, double-blinded trial

Presenters: Kane MAC¹, Gold MH², Coleman WP III³, Jones DH⁴, Tanghetti EA⁵, Alster TS⁶, Rohrer TE⁷, Burgess CM⁸, Shamban AT⁹

Affiliations: ¹Manhattan Eye, Ear & Throat Hospital, New York, NY; ²Tennessee Clinical Research Center, Nashville, TN; ³Tulane Health Sciences Center, New Orleans, LA; ⁴Skin Care and Laser Physicians of Beverly Hills, Los Angeles, CA; ⁵Center for Dermatology and Laser Surgery, Sacramento, CA; ⁶Washington Institute of Dermatologic Laser Surgery, Georgetown University Hospital, Washington, DC; ⁷Skin Care Physicians, Chestnut Hill, MA; ⁸Center for Dermatology and Dermatologic Surgery, Washington, DC; ⁹University of California Los Angeles, Los Angeles, CA

Background/Objective: Botulinum toxin type A is a well-established treatment for glabellar frown lines. Head-to-head comparison studies have demonstrated that incobotulinumtoxinA (Xeomin®) versus onabotulinumtoxinA (Botox®) result in comparable safety and efficacy for both cosmetic and therapeutic uses. In 2011, incobotulinumtoxinA was approved by the United States Food and Drug Administration (FDA) for improvement in the appearance of moderate-to-severe glabellar frown lines with a recommended dosage of 20 units (U).

This is the first large, multicenter, randomized, double-blinded, parallel-group study to compare the efficacy and safety of incobotulinumtoxinA versus onabotulinumtoxinA after a single 20U treatment to improve the appearance of glabellar frown lines.

Primary endpoint was response defined as a 1-point or greater improvement from baseline on the Facial Wrinkle Scale (FWS) at maximum frown one month from treatment.

Methods: Patients were randomized 1:1. Two-hundred and fifty female subjects 18 to 50 years of age (median age was 41 for both groups) with moderate-to-severe GFL on a 4-point FWS at maximum frown were included. Study duration was 120 days for each subject, plus the individual duration of screening (Day ?14 to 0). Eligible subjects received a single injection of the study treatment at Day 0 (baseline). Dose was 20U in both treatment groups; injection volume was 0.5mL.

Results: Primary endpoint was met. Primary efficacy analysis demonstrated equivalence of incobotulinumtoxinA and onabotulinumtoxinA at one month, with 95.7 percent of subjects in the incobotulinumtoxinA group achieving at least a 1-point improvement on FWS and 99.2 percent of subject in that onabotulinumtoxinA group achieving the same. Treatment satisfaction for both groups remained above 90 percent for the entire four-month treatment period. Fourteen (11.5%) subjects treated with incobotulinumtoxinA reported treatment-emergent adverse events (TEAE); 18 (14.1%) of subjects in the onabotulinumtoxinA group reported TEAEs. The most common TEAE among both groups was headache (incobotulinumtoxinA: n=7; onabotulinumtoxinA: n=5).

Conclusion: IncobotulinumtoxinA and onabotulinumtoxinA result in similar efficacy and safety profiles for the treatment of glabellar facial lines.

Funding: This study was funded by Merz North America, Inc.

Microfocused ultrasound in combination with diluted calcium hydroxylapatite for improving skin laxity and the appearance of lines in the neck and décolletage

Presenter: Casabona G

Affiliation: Cosmetic and Surgical Dermatology and Mohs Surgery, Clinica Vida, Sao Paulo, Brazil

Background/Objective: Skin laxity and wrinkling on the neck and décolletage can be age-revealing. The objective of this study was to evaluate the combined use of microfocused ultrasound with visualization (MFU-V) and diluted calcium hydroxylapatite (CaHA) for treating lines and wrinkles of the neck and décolletage.

Methods: Subjects with moderate-to-severe lines on the neck and/or décolletage were retrospectively enrolled. Prior to MFU-V treatment, a topical anesthetic (7% lidocaine, 7% prilocaine) was applied. For both the neck and décolletage, subjects were treated at two depths using the 7MHz transducer at a focal depth of 3.0mm and the 10MHz transducer at a depth of 1.5mm, applying 150 lines for each transducer per site. Immediately after MFU-V, subjects received treatment with CaHA (1.5 ml diluted 1:1 with 1.5 ml of 2% lidocaine solution). For the neck, CaHA was injected subdermally in microdroplets using a fanning technique with a 25G long cannula from four points of entrance starting on top of the lines and extending in a fan shape around the lines to cover the same area as the MFU-V (half a syringe per side). A similar technique was used for décolletage, but with three points of entry. Injections were followed by vigorous massage to ensure that the product was evenly dispersed. Subjects were assessed for skin laxity and wrinkling in the neck and décolletage at baseline and at 90 days (2 blinded, independent evaluators) using three validated scales: Merz Aesthetics Décolleté Scale and Fabi-Bolton Chest Wrinkle Scale (both scales range from 0=no wrinkles, 1=mild wrinkles, 2=moderate wrinkles, 3=severe wrinkles 4=very severe wrinkles); and Allergan Transverse Neck Lines Scale (ranging from 1=no wrinkles to 5=very severe wrinkles. Subject satisfaction was assessed using a 5-point scale (1=very unsatisfied, 2=unsatisfied, 3=neither satisfied nor dissatisfied, 4=satisfied, 5=very satisfied). Pain was assessed and adverse events (AEs) were documented.

Results: At baseline, 24 out of the 42 subjects were given a Grade 2 in the Allergan Transverse Neck Line Scale by Evaluator 1; Evaluator 2 placed 23 out of 42 subjects in the Grade 2 category. None of the subjects achieved a Grade 1 for neck lines at baseline. At 90 days, Evaluators 1 and 2 placed 30 and 27 subjects, respectively, in the Grade 1 category for neck lines. At baseline, 17 out of 18 subjects and 16 out of 18 subjects were given a Grade 2 or higher on the Merz Aesthetics décolletage wrinkles scale. At 90 days, 18 out of 18 subjects achieved a Grade 2 or lower from both evaluators. Using the subject satisfaction scale at baseline, the majority (64.3%) were neither satisfied nor dissatisfied with the neck lines treatment. At Month 3, the majority (54.8%) were very satisfied with the neck lines treatment. At baseline, the majority (66.7%) were neither satisfied nor dissatisfied with the décolletage treatment. At Month 3, 50.0 percent were satisfied and 44.4 were very satisfied with the décolletage treatment. Mild pain was experienced by 90 percent of subjects during the procedure; 10 percent reported no discomfort at all. All subjects experienced bruising, which resolved in three to seven days. No other AEs were reported.

Conclusion: Combining MFU-V with 1:1 diluted CaHA is effective in improving the appearance of neck and décolletage lines and wrinkles. Both procedures were well tolerated, and subject satisfaction was high.