Evaluation of five collagenase clostridium histolyticum‐aaes injection techniques for the treatment of cellulite on the buttock or thigh

Abstract

Background Given differences in buttock versus thigh cellulite, collagenase clostridium histolyticum‐aaes (CCH‐aaes) injection technique may impact treatment effects at these sites. Aim To evaluate efficacy and safety of 5 CCH‐aaes injection techniques. Methods A phase 2A, open‐label trial enrolled women with mild‐to‐severe cellulite (Clinician Reported Photonumeric Cellulite Severity Scale) on both buttocks or thighs. CCH‐aaes 0.84 mg was administered as 12 injections in each of two buttock or two thigh treatment areas (total dose, 1.68 mg) during three treatment sessions (Days 1, 22, 43). On Day 1, women were sequentially assigned to: Technique A = shallow injection/3 aliquots; Technique B = shallow injection/1 aliquot; Technique C = deep injection/1 aliquot; Technique D = deep and shallow injections/5 aliquots; or Technique E = shallow injection/4 aliquots. Change from baseline in Hexsel Cellulite Severity Scale (CSS) depression depth (range, 0 [no depressions] to 3 [deep depressions]) was assessed at Day 71. Safety was evaluated via adverse events. Results Sixty‐three women with buttock (n = 31) or thigh (n = 32) cellulite received ≥1 CCH‐aaes dose. For buttock cellulite, CCH‐aaes injection Technique A resulted in the greatest baseline‐adjusted improvement in CSS score on Day 71 (least‐squares mean, 1.17‐point improvement). For thigh cellulite, CSS score improvement was greatest with Technique D (least‐squares mean, 1.40‐point improvement). CCH injection Techniques A, D, and E were associated with more favorable safety profiles than Techniques B and C. Conclusion Different CCH‐aaes injection techniques are required with buttock (Technique A) versus thigh (Technique D) cellulite to optimize treatment outcomes.

Cellulite: Current Treatments, New Technology, and Clinical Management

“…20 As injection technique may influence the effects of CCH treatment, 5 different CCH injection techniques were evaluated in a Phase 2A, open-label study involving women with mild-to-severe cellulite. 21 Sixty-three women with buttock (n 5 31) or thigh (n 5 32) cellulite received 1 or more CCH doses. For the buttocks, Technique A (shallow injections with 3 aliquots) showed the greatest baselineadjusted improvement in CSS score on Day 71 (leastsquares mean, 1.17-point improvement).…”

Cellulite: Clinical Challenges and Future Perspectives

“…Based on the safety outcomes of Techniques B and C, 1-aliquot (bolus) techniques may not be optimal for buttock or thigh cellulite treatment, despite their efficacy. 17 The efficacy of Technique D (deep and shallow injections with 5 aliquots) was recently assessed in a real-world, openlabel, Phase 3b study (NCT04170296) of CCH-aaes for cellulite treatment in 153 women. 17,18 Injection-site bruising was reported in 86.42% of women treated on the posterolateral thighs and 93.06% of those treated on the buttocks.…”

“…17 The efficacy of Technique D (deep and shallow injections with 5 aliquots) was recently assessed in a real-world, openlabel, Phase 3b study (NCT04170296) of CCH-aaes for cellulite treatment in 153 women. 17,18 Injection-site bruising was reported in 86.42% of women treated on the posterolateral thighs and 93.06% of those treated on the buttocks. 18 A series of mitigation strategies for injection-site bruising after the first treatment session with CCH-aaes for buttock cellulite were assessed in a Phase 4, open-label trial (MOBI study; NCT04677712; 48 enrolled).…”

“…Based on the safety outcomes of Techniques B and C, 1-aliquot (bolus) techniques may not be optimal for buttock or thigh cellulite treatment, despite their efficacy. 17…”

“…The efficacy of Technique D (deep and shallow injections with 5 aliquots) was recently assessed in a real-world, open-label, Phase 3b study (NCT04170296) of CCH-aaes for cellulite treatment in 153 women. 17,18 Injection-site bruising was reported in 86.42% of women treated on the posterolateral thighs and 93.06% of those treated on the buttocks. 18…”