Evaluation of Collagenase Clostridium Histolyticum-Aaes (Qwo) Injection and the Development of Skin Discoloration By Dosing for the Treatment of Cellulite

Goals/Purpose: Cellulite affects 90% of women in the United States and is associated with the development of subdermal fibrous septae leading to changes in skin contour. Collagenase Clostridium Histolyticum (CCH) is an enzyme produced by the bacterium Clostridium histolyticum, which is thought to disrupt collagen septae and improve the overall appearance of cellulite. CCH was approved by the FDA in July 2020 for the treatment of moderate to severe cellulite in adult women. However, the significant bruising and subsequent discoloration and possibly staining of the skin has led to concerns for the use of CCH in the treatment of cellulite. The goal of the study is to evaluate the risk of development of skin discoloration based on dosing following CCH injections for cellulite. This study examined discoloration after treatment, not permanent staining.

Methods/Technique: A retrospective chart review was conducted on women who were treated with CCH for cellulite of the buttock or thighs who received at least one treatment of CCH. Patients were treated using 0.3 ml injections per dimple. Subjects were separated by dose volume, 4 ml (small dose) vs 8 ml (large dose) total per treatment. The chart was then reviewed for any mention of discoloration or staining after 30 days. Patients that did not proceed with further treatment because of the prolonged bruising, or seeked treatment for the discoloration were also considered positive for discoloration.

Results/Complications: Seventy-six women were included in the retrospective review. Two patients were lost to follow-up and did not respond to follow-up requests. Of this group, 41 women received 8 ml total of CCH per treatment (large dose group), and 35 women received 4 ml total of CCH per treatment (small dose group), however 2 of these were lost to follow-up, thus 33 women were included in the small vial group. Patients were evaluated after CCH treatment, each patient needed at least one follow-up to be included in the study. The large dose group had a discoloration rate of 34% while the small dose group had a discoloration rate of 15%.

Conclusion: The use of 4 mL (small vial) CCH injection dose is associated with decreased risk of developing injection site skin discoloration. This is not an evaluation of staining as some of these patients had short follow-up. This study was used to evaluate the risk of developing significant discoloration in the acute period that led the patient to discontinue treatments, seek treatment for the discoloration or verbalized concerns about the discoloration. Future studies are on going with tumescent and TXA treatments in combination with dosing.