Evaluation of 80 mg/ml calcium hydroxyapatite in the treatment of nasolabialfolds. Analysis of durability, safety, and efficacy at 12 months

Introduction: skin aging involves collagen fragmentation, which affects the extracellular matrix and accelerates deterioration. Photoaging, caused by ultraviolet radiation, motivates patients to seek corrective treatments. Calcium hydroxyapatite (CaHA) is a biocompatible filler that stimulates collagen production and provides safe and long-lasting results with a low complication rate. Correction of the nasolabial fold (NLF) is key to facial aesthetics, and CaHA has been shown to be effective in improving appearance and rejuvenating the face.

Objectives: demonstrate the efficacy and safety of Cientific Permanent Facial Implant II® (CaHA 80 mg/ml) for the correction of mild to moderate NLF.1

Materials and methods: a multicenter, prospective, open-label, longitudinal clinical study included 122 patients of both sexes (35–65 years old) with mild to moderate nasolabial folds (NLF). A maximum of 1 ml of CaHA filler was applied per fold, with the possibility of reapplication after 9 months in selected cases clinical parameters of efficacy, safety, and duration of effect were assessed using validated scales at baseline and at 3, 6, 9, and 12 months. The Lemperle scale was used for the initial patient assessment, and improvements were also assessed using this scale and the Global Aesthetic Improvement Scale (GAIS) and photographs of each follow-up.

Results: the study confirmed the safety and efficacy of Cientific Permanent Facial Implant II® (CaHA 80 mg/ml) for the correction of NLF, with mild adverse events such as pain, erythema, edema and ecchymosis, all transient and resolved spontaneously. At 12 months, the majority of patients maintained satisfactory results, with a high rate of improvement according to the GAIS scale. Only two patients were evaluated outside the protocol for asymmetries, and only one required correction. All participants attended the established follow-up visits, demonstrating adherence to the study and stability of the treatment.

Conclusions: Cientific Permanent Facial Implant II® (CaHA 80 mg/ml) was shown to be an effective and safe treatment for the correction of mild to moderate NLF. Reapplication after 9 months optimizes the duration of the effect in certain patients.