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10/29/2010
New hyaluronic acid gel outperforms bovine collagen
A new cohesive polydensified matrix hyaluronic acid (CPMHA, Belotero Balance; Merz) has outlasted bovine collagen in a 24-week study of nasolabial fold (NLF) correction and performed well in a 1.5-year follow-up study, according to Rhoda S. Narins, M.D., director of the Dermatology Surgery and Laser Center, White Plains, N.Y.; clinical professor of dermatology, New York University School of Medicine; and lead author of the studies.
New hyaluronic acid gel outperforms bovine collagen

Belotero is awaiting approval by the Food and Drug Administration
New product proves to be as safe as bovine collagen, and longer-lasting
Evaluation of patients in study with three scales produced the same results in each one
White Plains, N.Y. A new cohesive polydensified matrix hyaluronic acid (CPMHA, Belotero Balance; Merz) has outlasted bovine collagen in a 24-week study of nasolabial fold (NLF) correction and performed well in a 1.5-year follow-up study, according to Rhoda S. Narins, M.D., director of the Dermatology Surgery and Laser Center, White Plains, N.Y.; clinical professor of dermatology, New York University School of Medicine; and lead author of the studies.

Belotero is awaiting approval by the Food and Drug Administration. Meanwhile, Allergan will discontinue its collagen products human-derived CosmoPlast and CosmoDerm and bovine products Zyderm and Zyplast at the end of 2010. The company halted production of the products in 2009 but manufactured sufficient inventory to meet estimated market demand through the end of this year, according to Kelly Lao, manager of corporate communications. Johnson & Johnson announced in late 2009 that it was discontinuing Evolence (porcine collagen).


Belotero was injected in this patient's right nasolabial fold, and collagen in the left nasolabial fold. The photo was taken six months after injection. (Photo: Merz)

Once the non-animal-sourced CPMHA Belotero is approved, Dr. Narins says that dermatologists will be able to use it superficially, as dermatologists have used CosmoDerm and Zyderm, which were also used for NLF correction. Belotero can be used for deeper injection, as other hyaluronic acid fillers are, as well, she adds.


Study details

For the 24-week study, investigators randomized 118 subjects with moderate-to-severe bilateral NLFs to receive CPMHA and bovine collagen on opposite sides of the face. Before treating patients, investigators evaluated their NLFs using the Wrinkle Severity Rating Scale (WSRS) and tested patients for allergy to bovine collagen.

Investigators at six U.S. sites used any HA injection technique they preferred such as cross-hatching, serial injection or tunneling to achieve optimal aesthetic correction. They also gave pain-sensitive patients topical anesthetic or infraorbital nerve blocks before performing injections. Local anesthetic infiltration was not allowed, Dr. Narins says.

Researchers then evaluated results of initial treatments after two weeks and gave patients an optional touch-up treatment if needed, Dr. Narins says. Patients subsequently returned at weeks two, four, eight, 12, 16 and 24 after their last treatment for evaluation. Researchers also assessed safety through adverse event (AE) reports.

A dozen subjects failed to complete the study for various reasons. The study population was mainly female (92.4 percent) and Caucasian (96.6 percent), with skin type predominantly Fitzpatrick II or III and a mean age of 52.4 years.

Initial injection volumes averaged 1.16 mL for CPMHA, compared to 1.37 mL for collagen. Mean CPMHA injected at touch-up treatments was 0.81 mL (n = 94), versus 0.94 mL for collagen (n = 92).

Study results

At week 12, CPMHA demonstrated a 1.25 ( 0.63) point improvement in WSRS as judged by a blinded evaluator, versus 0.98 ( 0.72) for collagen (P <0.001. Narins RS, Coleman W, Donofrio L, et al. Dermatol Surg. 2010;36:730-740 [Published online April 20, 2010]).

Similarly, the difference between the two treatments based on the blinded investigator's WSRS scores favored CPMHA at weeks eight, 12, 16 and 24. The largest improvement in these scores for CPMHA was 1.38 points, which occurred at week eight. The greatest improvement for collagen (1.19 points) also occurred at week eight. Regarding treating investigators' WSRS evaluations, CPMHA outperformed collagen at weeks 12, 16 and 24.


Global Aesthetic Improvement Scale (GAIS) scores showed similar patterns, Dr. Narins says.

For example, GAIS scores given by treating physicians peaked at 3.29 (week four), versus 3.23 (week two) for collagen. From weeks two through 24, she adds, more than twice as many subjects maintained correction on the CPMHA side of the face as maintained correction on the collagen side.

Adverse events

Overall, 116 patients reported AEs of some type; 69 of these patients reported 167 AEs that investigators considered to be possibly, probably or definitely related to CPMHA, compared to 217 AEs possibly, probably or definitely related to collagen reported by 77 patients.

The only severe AE related to CPMHA that occurred in more than 5 percent of patients was injection site nodules (5.9 percent). Conversely, a greater number of severe AEs were related to collagen. Those occurring with an incidence of more than 5 percent were injection site nodules (7.6 percent) and injection site induration (5.9 percent).

Dr. Narins says the study's strengths include the fact it was double-blinded, and that investigators evaluated patients in three ways: using a validated wrinkle severity scale, a global assessment and a visual analogue scale corresponding with percentage improvements.

"All three scales showed the same results. As one would expect with a good HA, it lasted longer than bovine collagen, which lasts much longer than human collagen, and it was just as safe as bovine collagen," she says. "Therefore, I believe Belotero will take its place among the best of the HAs. The factors that will differentiate it are that it won't create a Tyndall effect, one can use it superficially as well as deeply, and it will be distributed by the company that distributes Radiesse (calcium hydroxylapatite, Merz). The duo of Radiesse with an HA is an excellent filler combination."

In a study extension, Dr. Narins says, investigators gave 85 patients who continued past 24 weeks CPMHA injections on both sides of the face and followed them for 1.5 years. Patients could be retreated at various intervals, she says. In this part of the study, "Approximately 80 percent of the patients were able to go 12 to 18 months before they were retreated." This part of the study will be published in Dermatologic Surgery in fall 2010, she says.

Disclosures: Dr. Narins was the principal investigator and consultant for Merz.

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