US EPA

2683796 

Journal Article 

What We Have Learned About Soft-Tissue Augmentation Over the Past 10 Years 

Sclafani, AP 

2014 

0 

JAMA Facial Plastic Surgery
ISSN: ‎2168-6076
EISSN: 2168-6092 

16 

1 

64-65 

English 

24091836 

10.1001/jamafacial.2013.1379 

WOS:000331371000013 

Rejuvenation of the aging lip with an injectable acellular dermal graft (Cymetra). Sclafani AP, Romo TR III, Jacono AA.



OBJECTIVE To evaluate the effects of Cymetra (micronized AlloDerm tissue) in rejuvenating the aging and atrophic lip.



PATIENTS Forty-four patients aged 32 to 80 years who reported age-related changes in the size and contour of the upper lip.



METHODS Patients were randomized to treatment with either Cymetra or glutaraldehyde cross-linked bovine collagen (Zyplast). Standardized photographs of each subject were taken before and after treatment initially and 3, 6, 9, and 12 months after initial treatment. Patients were monitored for signs of hypersensitivity, infection, and inflammation.



MAIN OUTCOME MEASURES Digital photographs were analyzed for changes in the nasolabial angle, percentage of the total lip accounted for by the exposed red lip in the midline and on the lateral view, the visible red upper and lower lip surface areas, and the anterior projection of the upper and lower lips.



RESULTS All patients tolerated treatment well without any significant local or systemic complications. Nineteen patients were treated with Cymetra and 25 with Zyplast. Cymetra-treated patients were more likely than Zyplast-treated patients at 12 months (3 months after the previous treatment) to have increased the percentage of red lip in the midline (84.6% vs 38.9%; P = .01), the vermilion height in the upper lip midline (84.6% vs 38.9%; P = .01), and the exposed red lower lip on the lateral view (69.2% vs 33.3%; P = .048) by at least 20%; increased the lower lip projection by 0.5 mm or more (69.2% vs 27.8%; P = .02); and decreased the nasolabial angle by at least 10 degrees (46.2% vs 16.7%; P = .07).



CONCLUSIONS Cymetra is a suspension of particulate dermal matrix that seems to increase the upper lip bulk, vermilion, and lower lip projection after a threshold of Cymetra has been administered. There are few differences in any measured long-term (3 months after treatment) variables until the 12-month visit, when there were statistically significantly more Cymetra-treated patients with improved lip aesthetics than those treated with Zyplast. With repeated treatments, Cymetra seems to accumulate, producing a long-term effect superior to Zyplast in many patients.