The Use of Type I and Type III Injectable Human Collagen for Dermal Fill: 10 Years of Clinical Experience in China

ABSTRACT

This article reports preclinical and clinical experience with a type I and type III injectable human collagen product derived from human sources (containing type I and type III collagen in a proportion of 44:56) utilized as a dermal filler. The preclinical study involves experiments characterizing the histological changes observed after type I and type III injectable human collagen injection in rats. The clinical trial is a study of 123 patients treated with type I and type III injectable human collagen for pitting skin deficiencies including furrow, superficial scar, and superficial atrophy. Histological observations from the preclinical study revealed that type I and type III injectable human collagen persisted for at least a year. The clinical trial showed that most patients were satisfied with the results, and a rating of excellent or good was achieved 90.2% of the time. The positive results lasted about 9 months after the first injection, 12 months after the second injection, and 18 months after the third injection. Reported side effects were slight redness and discomfort at or near the injection site. Type I and type III injectable human collagen is a safe and reliable biomaterial that can easily be used for soft tissue augmentation.

KEYWORDS

Soft tissue augmentation - human injectable collagen - animal studies - clinical trials

REFERENCES

• 1 Spira M, Rosen T. Injectable soft tissue substitutes.  Clin Plast Surg. 1993;  20 181-188
• 2 Diegelmann R F. Collagen metabolism.  Wounds. 2001;  13 177-182
• 3 Klein A W. Collagen substitutes: bovine collagen.  Clin Plast Surg. 2001;  28 53-62
• 4 Tiollier J, Dumas H, Tardy M, Tayot J-L. Fibroblast behavior on gels of type I, III and IV human placental collagens.  Exp Cell Res. 1990;  191 95-104
• 5 Sclafani A P, Romo 3rd T. Injectable fillers for facial soft tissue enhancement.  Facial Plast Surg. 2000;  16 29-34
• 6 Fagien S. Facial soft-tissue augmentation with injectable autologous and allogeneic human tissue collagen matrix (autologen and dermalogen).  Plast Reconstr Surg. 2000;  105 362-373
• 7 Ozgentas H E, Pindur A, Spira M, Liu B, Shenaq S. A comparison of soft-tissue substitutes.  Ann Plast Surg. 1994;  33 171-177
• 8 Liu B, Xu Z, Yu R. Experimental and clinical observation on wrinkle correction by medical cosmetic collagen injection.  Zhongguo Yi Xue Ke Xue Yuan Xue Bao. 1994;  16 197-200
• 9 Liu B, Spira M, Xu Z, Ozgentas E, Shenaq S M. A comparative study of gut suture, human amnion collagen, bovine skin collagen and Vicryl suture implants in rats.  Chin Med Sci J. 1997;  12 26-31
• 10 Jamall I, Finelli V, Que Hee S S. A simple method to determine nanogram levels of 4-hydroxyproline in biological tissues.  Anal Biochem. 1981;  112 70-75
• 11 Spira M, Liu B, Xu Z, Harrell R, Chahadeh H. Human anion collagen for soft tissue augmentation-biochemical characterizations and animal observations.  J Biomed Mater Res. 1994;  28 91-96
• 12 Francis M J, Williams K J, Sykes B C, Smith R. The relative amounts of the collagen chains alpha 1(1), alpha 2 and alpha1(III) in the skin of 31 patients with osteogenesis imperfecta.  Clin Sci. 1981;  60 617-623
• 13 Kligman A M, Armstrong R C. Histologic response to intradermal Zyderm and Zyplast (glutaraldehyde cross-linked) collagen in humans.  J Dermatol Surg Oncol. 1986;  12 351-357
• 14 Burke K E, Naughton G, Cassai N. A histological, immunological, and electron microscopic study of bovine collagen implants in the human.  Ann Plast Surg. 1985;  14 515-522
• 15 Siegle R J, McCoy J P, Schade W et al.. Intradermal implantation of bovine collagen: humoral immune responses associated with clinical reactions.  Arch Dermatol. 1984;  120 183-187
• 16 McCoy J P, Schade W J, Liegle R J et al.. Characterization of the humoral immune response to bovine collagen implants.  Arch Dermatol. 1985;  121 990-994