INTRODUCTION
Cellulite is a localized alteration of skin topography (eg, dimpling) and affects 80% to 98% of postpubertal women of all ages and ethnicities.1,2 Although the pathophysiology of cellulite has not been fully elucidated, data suggest the number, type, and orientation of the collagen-rich (fibrous) septae play a primary structural role.1,3 Other factors may include subcutaneous (SC) edema and fibrogenesis; SC adipose protrusion; and decreased dermal thickness with age.1-3 Several procedures and technologies that target the dermis and adipose tissue, in addition to fibrous septae, have shown improvements in skin texture and the dermal-SC interface; however, these improvements could be secondary to the effects of releasing the fibrous septae.4-7
Collagenase clostridium histolyticum (CCH) for injection is composed of 2 purified bacterial collagenases (AUX-I and AUX-II [clostridial class I and II collagenases]) that hydrolyze Types I and III collagen under physiologic conditions, resulting in disruption of collagen structures.8 CCH (0.58 mg; Xiaflex®, Endo Pharmaceuticals Inc., Malvern, PA) is currently indicated in the United States for the treatment of collagen-associated disorders (ie, adults with Dupuytren contracture [DC] with palpable cord or Peyronie’s disease [PD] in adult men with a palpable plaque and penile curvature deformity of ≥30 degrees at the start of therapy).8 Safety and immunogenicity data reported in patients with DC or PD demonstrated that CCH treatment is safe and generally well tolerated.9-12 Clinical trial and postmarketing surveillance data indicate that the most common adverse events (AEs) associated with CCH administration for the treatment of DC and PD were localized to the injection site, mostly mild to moderate in intensity, and transient.9-11 In 5-year posttreatment follow-up studies of patients with DC (n=644) or PD (n=280), no long-term safety issues with CCH therapy were identified.9,12 At 5 years posttreatment, >90% of patients treated with CCH for DC and PD were seropositive for anti—AUX-I and anti—AUX-II antibodies.9,12 Patients with DC or PD treated with CCH produced serum neutralizing antibodies; however, the presence of neutralizing antibodies in patients with PD or DC had no apparent effect on the clinical response or the frequency of adverse reactions.8,9
Collagenase clostridium histolyticum (CCH) for injection is composed of 2 purified bacterial collagenases (AUX-I and AUX-II [clostridial class I and II collagenases]) that hydrolyze Types I and III collagen under physiologic conditions, resulting in disruption of collagen structures.8 CCH (0.58 mg; Xiaflex®, Endo Pharmaceuticals Inc., Malvern, PA) is currently indicated in the United States for the treatment of collagen-associated disorders (ie, adults with Dupuytren contracture [DC] with palpable cord or Peyronie’s disease [PD] in adult men with a palpable plaque and penile curvature deformity of ≥30 degrees at the start of therapy).8 Safety and immunogenicity data reported in patients with DC or PD demonstrated that CCH treatment is safe and generally well tolerated.9-12 Clinical trial and postmarketing surveillance data indicate that the most common adverse events (AEs) associated with CCH administration for the treatment of DC and PD were localized to the injection site, mostly mild to moderate in intensity, and transient.9-11 In 5-year posttreatment follow-up studies of patients with DC (n=644) or PD (n=280), no long-term safety issues with CCH therapy were identified.9,12 At 5 years posttreatment, >90% of patients treated with CCH for DC and PD were seropositive for anti—AUX-I and anti—AUX-II antibodies.9,12 Patients with DC or PD treated with CCH produced serum neutralizing antibodies; however, the presence of neutralizing antibodies in patients with PD or DC had no apparent effect on the clinical response or the frequency of adverse reactions.8,9
