Injections of investigational cellulite treatment collagenase clostridium histolyticum (CCH, Endo International) improved the appearance of cellulite in the buttocks in two phase 3 studies.
Compared to subjects receiving placebo, those treated with CCH achieved at least a 2-level composite improvement in cellulite severity in the treated buttocks 28 days after the last treatment, or at day 71, compared to subjects receiving placebo.
But one cosmetic surgeon, who has no ties to the company, isn’t yet convinced of the therapy’s value among cellulite treatments.
The problem is outcomes from most cellulite treatments don’t last and these results extend to only 28 days after the last treatment, according to Alexander W. Sobel, D.O., president of the American Board of Cosmetic Surgery.
“But I’m interested. I want to see where this goes,” Dr. Sobel tells The Aesthetic Channel.
Endo International released results of the identical RELEASE-1 and RELEASE-2 multicenter studies in early November in a press release. The company studied a total of 846 women 18 and older with moderate to severe buttock cellulite to 28 days after the last CCH treatment. Subjects received up to three CCH treatments of up to 12 injections each in the buttocks or placebo treatments, about 21 days apart.
Among those receiving CCH in RELEASE-1, 7.6% experienced significant improvement in the composite investigators' and patients' assessments of the appearance of cellulite, as measured by the Clinician Reported- Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient Reported- Photonumeric Cellulite Severity Scale (PR-PCSS) at day 71, compared to 1.9% of placebo subjects. In RELEASE-2, the percentages were 5.6 in the CCH group versus 0.5 receiving placebo. Endo International helped to develop scales used in the study, according to the release.The active treatment passed all but one of eight secondary endpoints in both studies. The secondary endpoints measured investigators' and patients' assessments of the appearance of cellulite, patient satisfaction and more. For example, 54.3% of subjects in RELEASE-1 and 46.8% in RELEASE-2 who received CCH reported being "satisfied" or "very satisfied" with treatment at day 71, compared to 25.8% and 13.6% of placebo subjects, respectively. And while those receiving CCH in RELEASE-1 demonstrated a statistically significant improvement in the composite investigator and patient assessments of the appearance of cellulite, as measured by a 2-level improvement in both the CR-PCSS and PR-PCSS scores, at day 71, the endpoint failed to show statistical significance in RELEASE-2.
Subjects tolerated CCH well, with most adverse events, such as bruising, as well as injection site pain, discoloration, nodules and pruritus, being mild to moderate, according to the release.
“Cellulite is tough,” Dr. Sobel says. “What makes it tough is you have these ligaments — these myofascial cutaneous ligaments — that are basically tethers from the underlying muscle structure to the skin. A variety of treatments over the years have been attempted to improve the appearance of cellulite, but they tend to fail in the long-term. So, whenever I evaluate a cellulite treatment, I’m first and foremost interested in is, it really doing anything to those ligaments in the long-term to improve the appearance?”
Bacteria-derived collagenase clostridium histolyticum is used to treat Dupuytren's contracture and Peyronie's disease in adults. It breaks down collagen.
“This product is a novel way of approaching cellulite in terms of trying to dissolve those ligaments,” Dr. Sobel says.
In the past, doctors have used devices to sever the bands, including the Toledo V (Wells Johnson) liposuction cannula, more affectionately known as the “pickle fork,” according to Dr. Sobel. Still, the dimples of cellulite often returned, he says.
“Cynosure came out with a very extensive side-firing laser that was supposed to cut these ligaments and in the long-term didn’t work terribly effectively either. There are a number of technologies that heat up the skin on top and tend to improve basically the tightness of the quilt in between these little quilting tethers. They improve the appearance of cellulite for a time but don’t defeat the ligamentous structure,” he says. “If this works in the long-term, that’s something that is really exciting.”
But even if results don’t last years after treatment, patients often see benefit from temporary reduction of their cellulite, Dr. Sobel says.
“That’s especially if the treatment is minimally invasive, carries low risk and fits in the beauty budget. So, I think there are some aspects of this to be excited about even before the presentation of long-term data,” he says.
Among today’s treatments, Subcision, a registered trademark with the Cellfina (Ulthera), boasts the longest FDA clearance for a cellulite treatment at three years.