A hyaluronic acid-based micro-filler improves superficial wrinkles and skin quality: a randomized prospective controlled multicenter study

Abstract

Background

NCTF®135HA is a bio-revitalizing solution containing hyaluronic acid designed to compensate for skin dehydration, fatigue, and fine wrinkles associated with endogenous and environmental aging.

Methods

We conducted a randomized, active-controlled study to evaluate the efficacy and tolerability of NCTF®135HA injections on the face (crow’s feet), neck, and décolleté regions. Subjects were randomly assigned (3:1) to receive three NCTF®135HA treatment sessions plus twice-daily anti-aging moisturizer cream or cream alone (control). The primary outcome was the reduction in superficial wrinkles between baseline and Day (D)75 in the three areas, assessed by profilometric measures, clinical scoring, subjective changes, and tolerability.

Results

146 subjects were randomized to NCTF®135HA (n = 107) or control (n = 38). At D75 and D120, NCTF®135HA significantly reduced wrinkles in all three areas and improved facial radiance scores compared with the control. Skin hydration significantly increased 7 d after the last NCTF®135HA injection. Self-esteem scales showed statistically significant improvements at D75 and D120 in subjects treated with NCTF®135HA versus baseline. Most adverse events were mild, resolved within 48 h, and were related to the injection procedure.

Conclusion

NCTF®135HA is an effective and well-tolerated treatment to reduce the skin signs of aging. The results are significantly superior to a routine anti-aging cream alone.

(Funded by Laboratories FILLMED; ID-RCB number: 2018-A03167-48; clinicaltrials.gov number: NCT05609617)

Keywords:

• Skin rejuvenation
• filler
• non-crosslinked hyaluronic acid
• biorevitalization
• mesotherapy
• neck rejuvenation
• décolleté rejuvenation

Acknowledgments

A special thanks to Karim Nadra, Shannel Curic, Sophie Mac, Jean-Marie Sainthillier, Audrey Binabout and Marie-José Moschetti for their precious participation in the study set up and execution and data analysis. This article could not be finalized without their help. Mark Greener and Marian East of MedSense Ltd provided editorial assistance funded by Laboratoires FILLMED.

Disclosure statement

Ferial Fanian and Hanane Issa are employees of Laboratoires FILLMED. The other authors report there are no competing interests to declare.

Data availability statement

There is no associated data available.

Additional information

Funding

This study was funded by Laboratories FILLMED.