A randomized, bilateral, prospective comparison of calcium hydroxylapatite microspheres versus human-based collagen for the correction of nasolabial folds.

BACKGROUND: Current soft tissue fillers are a compromise between ease of use, duration of correction, reactivity, and cost. A product utilizing calcium hydroxylapatite (CaHA) is currently being used as a soft tissue filler.
OBJECTIVE: The objective was to compare the efficacy and safety of CaHA microspheres versus human-based collagen for the correction of nasolabial folds.
MATERIALS AND METHODS: Four centers enrolled 117 subjects with moderate to deep nasolabial folds. Subjects received CaHA on one side of the face and human collagen on the other. Up to two touch-ups were allowed. A blinded panel of experts evaluated subject photographs from initial and follow-up visits.
RESULTS: Seventy-nine percent of subjects had superior improvement on the CaHA side through 6 months (p<.0001). For optimal correction, significantly less volume and fewer injections were needed for CaHA than for collagen (p<.0001). Adverse event rates were comparable, with some increase in bruising and edema for CaHA-treated sides. Adverse event duration was similar for both groups and generally resolved within 14 to 21 days.
CONCLUSION: This CaHA-based product gives significantly longer-lasting correction of nasolabial folds compared to human collagen. Less total material and fewer injections are required. The adverse event profile of the product is similar to the collagen-based product.

RCT Entities:   Population Interventions Outcomes