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. 2021 Aug;14(8):34-40.
Epub 2021 Aug 1.

Evaluating the Effect of Incobotulinumtoxin A for Glabellar, Forehead, and Crow's Feet Lines Using A High Dilution

Sheila C Barbarino  1   2   3   4 , Jani A J van Loghem  1   2   3   4 , Cheryl M Burgess  1   2   3   4 , Niamh Corduff  1   2   3   4
Affiliations

Evaluating the Effect of Incobotulinumtoxin A for Glabellar, Forehead, and Crow's Feet Lines Using A High Dilution

Sheila C Barbarino et al. J Clin Aesthet Dermatol. 2021 Aug.

Abstract

Background: As aesthetic preferences have evolved and patients wish their muscles to be relaxed, but not frozen, a higher dilution of incobotulinumtoxinA (INCO) has allowed for increased spread using fewer units, yet no studies to date have investigated the efficacy, longevity, and safety of hyperdiluted INCO.

Objective: We evaluated the effect of incobotulinumtoxinA (INCO) in glabellar, forehead, and lateral periorbital lines using a high dilution.

Methods: Subjects with moderate-to-severe upper facial lines at rest according to the Merz Aesthetics Scales™ (Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany) received 15U of INCO to the glabellar (n=4 injection sites), 10U to the rest of the forehead (n=10 injection sites), and 5U to the lateral periorbital lines (n=3 injection sites/eye). Primary outcomes were physician- and subject-rated improvement at one month using the Global Aesthetic Improvement Scale (GAIS) and changes in line severity using the Merz Aesthetics Scales™.

Results: The study included 15 women aged 35 to 65 years. At one month, physician GAIS scores indicated 91.2% of subjects were very much improved and 8.8% were much improved; 91.5%, 78.0%, and 57.6% of participants remained at least improved at four, five, and six months, respectively. Subject GAIS scores at one month were in agreement with physician scores. At one month, an improvement of at least one point in Merz Aesthetics Scales™ scores in glabellar, forehead, and lateral periorbital lines was reported in 88.9%, 98.3%, and 94.8% of participants, respectively. Subject satisfaction was high throughout the study. No treatment-related adverse events were observed.

Conclusion: Hyperdilute INCO was effective at improving overall appearance and reducing line severity in individuals with moderate-to-severe upper facial lines. Patient satisfaction was maintained up to six months and treatment was well tolerated.

Keywords: IncobotulinumtoxinA; glabellar lines; horizontal forehead lines; hyperdiluted; lateral periorbital lines.

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Conflict of interest statement

DISCLOSURES: Dr. Barbarino is a consultant for Merz, Lumenis, Alastin Skincare, Skinceuticals, Syneron/Candela, and Sinclair Pharmaceuticals. Dr. Burgess is a consultant for Merz and Allergan. Dr. van Loghem is a consultant for Merz, Allergan, and Ipsen. Dr. Corduff is a clinical advisor, investigator, and speaker for Merz and medical advisory board member for Establishment Labs.

Figures

FIGURE 1.
FIGURE 1.
Injection plan for treating A) frontalis, B) glabellar, and C) crow’s feet indications
FIGURE 2.
FIGURE 2.
Physician Global Aesthetic Improvement Scale rating for subject appearance at each study visit
FIGURE 3.
FIGURE 3.
Before and after photos for each indication showing no dynamic wrinkles at maximum contraction one month after treatment with diluted incobotulinumtoxin A for A, B) frontalis; C, D) glabellar; and E, F) lateral periorbital lines
FIGURE 4.
FIGURE 4.
Before and after photos of subject treated with dilute incobotulinumtoxin A for forehead lines shown at maximum contraction at each follow-up visit. A) Pretreatment image; Posttreatment, B) One month, C) Two months, D) Three months, E) Four months, F) Five months, G) Six months
FIGURE 5.
FIGURE 5.
Subject Global Aesthetic Improvement Scale rating for subject appearance at each study visit.
FIGURE 6.
FIGURE 6.
Proportion of patients with an improvement of at least one point on the Merz Aesthetics Scales™ at each follow-up visit
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