The Effects of a Non-crossed-linked Hyaluronic Acid Gel on the Aging Signs of the Face versus Normal Saline: A Randomized, Double-blind, Placebo-controlled, Split-faced Study

Abstract

Background: Skin bio-revitalization improves skin quality globally; it permits the rejuvenation of the skin by increasing hydration and by reconstructing an optimal physiological environment for the skin cells together with a micro-filling effect.

Objective: To assess the comparative efficacy of a non-cross-linked hyaluronic acid (NCHA) preparation (M-HA®10, FILLMED Laboratories, France) on fine lines reduction and on skin hydration, radiance and mechanical properties, after three sessions of multiple intradermal injections, active versus placebo, on the face of subjects presenting aging signs.

Methods: Thirty healthy subjects received filler injections on one side and a control solution (saline) on the contralateral side of the face. Fine lines depth, skin hydration, and mechanical properties were evaluated using instrumental methods. Skin radiance, cheek fold and crow's feet were scored clinically. In addition, Investigator and subject satisfaction rates were evaluated by the Global Aesthetic Improvement Scale and a subject self-assessment questionnaire.

Results: Ten days after the last multi-injection session, the following significant results were observed compared to the control: a reduction of both crow's feet wrinkle depth (in the 110 to 1000µm range, -10% for NCHA and +7% for control) and clinical scoring of cheek wrinkles, and increases in skin radiance and hydration (+35%) and also skin firmness (+27%). The Investigator found that NCHA either improved or much improved the aesthetic aspect on 82% of subjects whereas no improvement was found on the saline side. Subjects found that NCHA significantly reduced wrinkles and increased both skin firmness and elasticity.

Conclusion: Intradermal injection of NCHA can improve the quality of facial skin with aging signs by reducing fine wrinkles and improving hydration, firmness and radiance.

Keywords: Non-cross-linked hyaluronic acid; mesotherapy; skin bio-revitalization.

FIGURE 1.

Injection procedure

FIGURE 2.

Evolution of skin radiance score (mean ± sem).

FIGURE 3.

Evolution of skin hydration (mean ± sem).

FIGURE 4.

Shows the evolution of residual deformation for both treatments (mean ± sem).

FIGURE 5.

Distribution of Investigator and Subject GAIS as a function of visits.

FIGURE 6.

Subject Self-assessment questionnaire, frequency of positive responses and treatment comparisons.

FIGURE 7.

Before-after photo of two side of the face: a) M-HA 10 side at baseline, b) M-HA 10 at day 53, c) Placebo side at baseline, d) Placebo side at Day 53. As showed, there is not visible result on placebo side while the skin quality and wrinkle improvement is clearly visible at treatment side.