Safety, efficacy of hyaluronic fillers studied

January 1, 2008

A prospective, open-label Phase 4 study evaluated three low concentration hyaluronic acid fillers for correction of nasolabial folds in 119 persons with skin of color. The results showed clinically significant improvement was achieved and maintained in most patients during follow-up of 24 weeks. No patients experienced permanent pigmentary changes, keloids, hypertrophic scarring, or other significant adverse events.

Key Points

Dr. Grimes and other investigators randomized 119 patients at each of three investigational sites to correction of nasolabial folds with one of three Allergan products: Hylaform (hylan B gel), Hylaform Plus (hylan B gel) or Captique (non-animal stabilized hyaluronic acid).

The assigned filler was injected intradermally into both nasolabial folds in accordance with the instructions for use in the labeling. The volume delivered was at the discretion of the investigator based on the length and depth of the nasolabial fold.

The efficacy evaluations showed the fillers provided smooth, natural-looking correction in these darker skin-type patients, with the majority of subjects showing a clinically significant benefit (1 point or greater improvement in the 6-point severity rating scale) at each visit throughout the follow-up. The treatment was also safe and well-tolerated.

Overall, injection-related adverse events occurred at a low incidence, were mild, and generally resolved within seven days.

Of those index adverse events, hyperpigmentation was the only one observed, and it occurred in only three patients (2.5 percent), Dr. Grimes tells Dermatology Times.

"Fillers have the potential to play a tremendous role in treating the aging face in skin of color, where the most prominent findings are soft tissue changes as a result of loss of volume and the effects of gravity. Tear trough deformities, prominent nasolabial folds, marionette lines and jowl formation are common in darker-skinned individuals and amenable to correction with filling agents. However, few people of color were included in the premarketing studies of available fillers," Dr. Grimes says.

"The FDA mandated this phase 4 study to especially investigate safety, because persons with skin of color are at increased risk to develop pigmentation and scarring disorders following skin trauma, such as filler injections," Dr. Grimes says.

Enrolled patients had to be Fitzpatrick phototype IV-VI and be seeking correction of nasolabial folds. Fold severity was rated with a validated 6-point scale (0 = no wrinkle; 5 = very deep wrinkle, redundant fold). Of the 119 subjects enrolled, 97.5 percent completed the 24-week study.

Mean age of the subjects across the three filler groups ranged from 41 to 54 years. The majority were female (>90 percent) and had skin type V or VI.

Mean nasolabial fold score at baseline was 3.4 (moderately deep to deep lines). Maximum improvement postinjection was achieved at the first follow-up visits at weeks two and four when the mean severity scores in all filler groups were less than "1" (just perceptible).

Disclosure: The study was funded by Allergan. Dr. Grimes has performed clinical research for and/or served as a consultant for Allergan, Inamed, Galderma, Astellas, SkinMedica, Altana, Young Pharmaceuticals, Stiefel Laboratories, GammaCan and Combe.