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A Randomized, Dose-Escalating, Double-Blind Study to Evaluate Abobotulinumtoxina for the Treatment of Moderate-to-Severe Glabellar Lines

Paul Lorenc, Lorenc Aesthetic Plastic Surgery Center and MediSpa, New York, NY, John H. Joseph, MD, The Clinical Testing Center of Beverly Hills, Beverly Hills, CA, Amir Moradi, MD, MBA, Private Practice, Vista, CA, Kyle Coleman, MD, Etre Cosmetic Dermatology and Laser Center, New Orleans, LA, Glynis Ablon, MD, Ablon Skin Institute and Research Center, Manhattan Beach, CA, Joely Kaufman-Janette, MD, Skin Research Institute, LLC, Coral Gables, FL, Sue Ellen Cox, MD, Aesthetic Solutions, PA, Chapel Hill, NC, Andrew Campbell, MD, Quintessa Aesthetic Center - EthiQ2 Research, LLC, Mequon, WI, Steve Dayan, MD, Private Practice, Chicago, IL; DeNova Research, Chicago, IL and Girish Munavalli, MD, Dermatology, Laser & Vein Specialists of the Carolinas, Charlotte, NC
Goals/Purpose:

To evaluate the efficacy and safety of a single dose of abobotulinumtoxinA (50U, 75U, 100U or 125U) versus placebo in the treatment of moderate-to-severe glabellar lines, and to investigate the impact of dose escalation on duration of effect. The primary objective was to evaluate Month 1 composite investigator- and subject-assessed responder rate (≥2-grade improvement and glabellar line severity scale [GLSS] score 0 or 1) at maximum frown.

Methods/Technique:

In this 9-month, dose-escalating, double-blind Phase II study (NCT03736928), subjects received a single dose of abobotulinumtoxinA or placebo (randomized 4:1) for the treatment of moderate-to-severe glabellar lines. Stepwise enrollment was applied for the two highest dose levels to ensure safety. Assessments included investigator- and subject-assessed GLSS, time to onset, subject satisfaction (questionnaire; FACE-Q1-3), aesthetic improvement and adverse events.

Results/Complications:

Each abobotulinumtoxinA dose group and the placebo group included ~80 subjects. The primary objective was met; the Month 1 composite 2-grade improvement responder rate was 80% (50U), 89% (75U), 90% (100U), and 95% (125U) compared with 3% (placebo), p<0.001. Median time to onset was 2 days; Month 9 responder rates (≥1-grade improvement, investigator-assessed) were 18% (50U), 26% (75U), 35% (100U) and 31% (125U). Aesthetic improvement was high. At Month 9, ≥89% of subjects reported natural-looking results, and ≥92% wanted to receive the same treatment again. Treatment-related adverse events were predominantly mild, transient, and similar across doses.

Conclusion:

AbobotulinumtoxinA was efficacious and well-tolerated across all doses, with rapid onset, duration up to 9 months and high subject satisfaction and aesthetic improvement.

References

  1. Klassen AF, Cano SJ, Schwitzer JA, Baker SB, Carruthers A, Carruthers J, Chapas A, Pusic AL. Development and Psychometric Validation of the FACE-Q Skin, Lips, and Facial Rhytids Appearance Scales and Adverse Effects Checklists for Cosmetic Procedures. JAMA Dermatol. 2016;152(4):443-51.
  2. Klassen AF, Cano SJ, Schwitzer J, Scott A, Pusic AL. FACE-Q scales for health-related quality of life, early life impact and satisfaction with outcomes and decision to have treatment: development and validation. Plast Reconstr Surg. 2015;135:375-86
  3. Panchapakesan V, Klassen AF, Cano SJ, Scott AM, Pusic AL. Development and Psychometric Evaluation of the FACE-Q Aging Appraisal Scale and Patient-Perceived Age Visual Analog Scale. Aesthetic Facial Surgery, 2013; 33:1099-1109
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