A Prospective, Randomized, Double-Blind, Split-Face, Comparative Study to Evaluate the Efficacy and Safety of DKL23 and Juvéderm Volift for Correcting Moderate-to-Severe Nasolabial Folds

Abstract

Background: Hyaluronic acid dermal fillers are used for multiple indications, including wrinkle correction and restoration of volume/fullness.

Objectives: The aim of this study was to compare the efficacy and safety of 2 hyaluronic acid products for correcting moderate to severe nasolabial folds (NLFs).

Methods: A prospective, randomized, double-blind, split-face study was undertaken. The subjects' left and right NLFs were randomly allocated for treatment with DKL23 or Juvéderm Volift. Follow-up was conducted at 1, 3, 6, and 9 months. The changes from baseline on the Wrinkle Severity Rating Scale and the Global Aesthetics Improvement Scale were evaluated. Posttreatment adverse events (AEs) were recorded.

Results: Forty-eight women (median age, 57.0 years) with Type I to VI skin were enrolled. Both treatments showed statistically significant improvement (P < .0001) in NLFs according to the Wrinkle Severity Rating Scale score from baseline to each of the time points assessed. The improvement in NLFs was maintained until the end of the study (9 months). Furthermore, the change from baseline to each of the time points assessed was similar between DKL23 and Juvéderm Volift. Investigator- and subject-rated Global Aesthetics Improvement Scale scores showed similar rates of improvement (indicated by the sum of responses of improved, much improved, or very much improved) between the 2 products. The AEs reported in the study were in line with previous and expected experience after injection of hyaluronic acid dermal fillers. The types of AEs, their rates, intensity, and duration were comparable between the 2 products.

Conclusions: DKL23 improved NLF severity from baseline and for up to 9 months, and the results were comparable to the improvement shown by Juvéderm Volift. Treatment was safe and well tolerated.

Figure 1.

WSRS measured at baseline and each follow-up visit during the study. Each data point depicts the mean and standard deviation of WSRS of 40 subjects treated with DKL23 in one nasolabial fold and Juvéderm Volift in the other nasolabial fold. The WSRS score was evaluated by an investigator who was blinded to the treatment allocation. *P < .0001 for the change in WSRS from baseline. WSRS, Wrinkle Severity Rating Scale.

Figure 2.

Percentage of responders. Responders were defined as subjects with a ≥1-point change in WSRS score from baseline. Each data point depicts the percentage of responders out of 40 subjects treated with DKL23 in one nasolabial fold and Juvéderm Volift in the other nasolabial fold.

Figure 3.

Representative photographs of 3 subjects. (A-E) A 58-year-old woman with Fitzpatrick Type II skin who was treated with DKL23 in the right NLF and with Juvéderm Volift with lidocaine in the left NLF: (A) baseline, (B) 1 month posttreatment, (C) 3 months posttreatment, (D) 6 months posttreatment, (E) 9 months posttreatment. (F-J) A 55-year-old woman with Fitzpatrick Type II skin who was treated with DKL23 in the left NLF and with Juvéderm Volift with lidocaine in the right NLF: (F) baseline, (G) 1 month posttreatment, (H) 3 months posttreatment, (I) 6 months posttreatment, (J) 9 months posttreatment. (K-O) A 51-year-old woman with Fitzpatrick Type III skin who was treated with DKL23 in the right NLF and with Juvéderm Volift with lidocaine in the left NLF: (K) baseline, (L) 1 month posttreatment, (M) 3 months posttreatment, (N) 6 months posttreatment, (O) 9 months posttreatment. NLF, nasolabial fold.

Figure 4.

Investigator-rated Global Aesthetics Improvement Scale score during the study. Each bar depicts the percentage of subjects who showed at least improvement from baseline as rated by the investigator.

Figure 5.

Subject-rated Global Aesthetics Improvement Scale score during the study. Each bar depicts the percentage of subjects who showed at least improvement from baseline as rated by the subject.

Figure 6.

Subject satisfaction. Each bar depicts the percentage of subjects who were satisfied and very satisfied with the products at each follow-up visit.