WASHINGTON -- Injectable collagenase clostridium histolyticum (CCH) may be an effective treatment option for women with cellulite on the buttocks, according to researchers here.
Based on results from two randomized, double-blind, placebo-controlled, phase III trials (Release-1 and Release-2), CCH (Xiaflex) significantly improved cellulite severity in women with moderate to severe cellulite on the buttocks, reported Joely Kaufman, MD, of the Skin Associates of South Florida in Coral Gables, and colleagues, at the American Academy of Dermatology meeting.
For Release-1, 7.6% of CCH responders and 1.9% of placebo responders had a ≥2-level composite response at day 71. As for Release-2, 5.6% of CCH responders and 0.5% of placebo responders had a ≥2-level composite response at day 71.
For Release-1, 64.3% of CCH and 38.5% of placebo responders had improvements in Subject Global Aesthetic Improvement Scale (S-GAIS) response at day 71. For Release-2, 58.9% of CCH and 22.3% of placebo responders saw improvements in S-GAIS, according to the researchers.
The findings indicated the "administration of CCH for cellulite was generally well-tolerated," Kaufman said.
Xiaflex was approved by the FDA in 2010 for the treatment of adult patients with Dupuytren's contracture with a palpable cord. In a 2014 study, men with moderate to severe Peyronie's disease had clinically and subjectively meaningful improvement a year after treatment with the agent.
Responders were defined as participants who had a ≥2-level improvement for the target buttock from the investigation's baseline, based on clinician-reported photonumeric cellulite severity scale (CR-PCSS) and patient-reported PCSS (PR-PCSS), she explained.
Prior research has shown that collagen-rich subdermal septae has an effect on cellulite, and current investigations are looking at novel presentation of CCH to use enzymatic interference of the septae to enhance cellulite-related contour alterations, resulting in skin smoothing, Kaufman said.
"I think it's a new exciting technology that we could have for the treatment of cellulite, since we all know that there are so few treatments, and so many women complain and suffer from cellulite and its implications," Kaufman told MedPage Today. "So really this is a novel approach -- we haven't seen an injectable for cellulite before -- so I think this is the first stage in showing that it really did have clinical efficacy, and then we'll go on to later stages deciding exactly how to use it,"
For Release-1, Kaufman's group evaluated 210 CCH responders and 213 placebo responders. For Release-2, 214 CCH responders and 206 placebo responders were assessed. Responders had a BMI range of 18-67, an age range of 18-78 years, and were represented based on Fitzpatrick category.
"We really enrolled a lot of patients with all different body types, with all different types of cellulite, different age groups, different skin types, and I think we may need to start focusing on which cellulite responds the best, which type, whether it's lower BMI patients or higher BMI patients," Kaufman noted.
Participants had both buttocks injected with the same treatment of either CCH or placebo. For the CCH participants, they received 0.84 mg of the treatment per buttock.
For Release-1, 81.0% of CCH participants and 38.0% of placebo participants had at least one adverse event as did 95.3% of CCH participants and 42.7% of placebo participants in Release-2.
For both trials, the mean CR-PCSS scores were:
- Day 1: 3.4 for Release-1 and 3.4 Release-2
- Day 22: 3.2 and 3.0
- Day 43: 2.8 and 2.7
- Day 71: 2.7 and 2.6
Most of the adverse events observed in CCH-treated patients were mild/moderate and injection-site related, such as bruising, pain, nodule, pruritus, erythema, and discoloration.
Kaufman reported that an ongoing, phase III, open-label, 5-year trial of CCH, sponsored by Endo Pharmaceuticals, will assess the durability of response of CCH for the treatment of cellulite in women.
Kaufman and co-authors disclosed relevant relationships with Endo Pharmaceuticals. Some co-authors are company employees.
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