NCT05609617

Evaluation of Anti-aging Performance and Tolerance of a Hyaluronic Acid-based Filler NCTF135HA®

Evaluation of Anti-aging Performance and Tolerance of a Hyaluronic Acid-based Filler NCTF135HA® Medical Device, on Filling the Superficial Wrinkles and on Skin Quality: HEBE2 Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 146 (actual)
• Sponsor: Laboratoires FILLMED · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

The NCTF135HA medical device from Laboratoires FILL-MED by FILORGA Company is an injectable solution for the treatment of wrinkles and biorevitalization of injected mature skin using a multi-injection technique with CE marking. It is a viscoelastic injectable solution of 1% hyaluronic acid (10mg/ml), non-crosslinked of non-animal origin, obtained by biofermentation, resorbable, opalescent, sterile and apyrogenic. NCTF135HA is an anti-aging viscoelastic solution for the revitalization and intense hydration of tired or dull skin, the treatment of wrinkles and the redensification of mature or sagging skin. This hyaluronic acid solution is intended to be injected into the superficial dermis to compensate for the loss of moisture. Given the expected impact of the injection procedure of the biorevitalization solution on wrinkles, the primary endpoint was chosen to evaluate the effectiveness of the treatment on wrinkles.

Detailed description

Aging is a complex phenomenon that includes many structural changes over time. At the level of the face, the ageing of the superficial plane (skin) and that of the support structures (fat, muscles and bones) are distinguished. On the skin, there is a reduction in cell renewal, dehydration, loss of radiance, elasticity, firmness and the appearance of fine lines and wrinkles. The NCTF135HA medical device from Laboratoires FILL-MED by FILORGA Company is an injectable solution for the treatment of wrinkles and biorevitalization of injected mature skin using a multi-injection technique with CE marking. It is a viscoelastic injectable solution of 1% hyaluronic acid (10mg/ml), non-crosslinked of non-animal origin, obtained by biofermentation, resorbable, opalescent, sterile and apyrogenic. NCTF135HA is an anti-aging viscoelastic solution for the revitalization and intense hydration of tired or dull skin, the treatment of wrinkles and the redensification of mature or sagging skin. This hyaluronic acid solution is intended to be injected into the superficial dermis to compensate for the loss of moisture. Given the nature of the process under study, it is difficult to propose as a control a solution that includes only saline as an injection product. Indeed, the subject would suffer harm related to injections without a priori benefiting from them. In addition, a DM injected using a multi-injection technique is a whole combining micro-injections by themselves and the products injected. Therefore, it is proposed to use as a control group subjects who will be evaluated in a similar way to those treated by injections of the biorevitalization solution but whose only cosmetic care will consist of the application of a moisturizing cream. This cream, used daily, will also be applied by the subjects in the injection group Given the expected impact of the injection procedure of the biorevitalization solution on wrinkles, the primary endpoint was chosen to evaluate the effectiveness of the treatment on wrinkles. For the face, this criterion will be the evolution of the average volume of crow's feet wrinkles (depth and surface). It will be measured centrally by a validated 3D imaging technique. For the neck and décolleté areas that will also be studied, this assessment will be replaced by clinical scoring using photographic scales developed specifically for these areas (the typology of this type of wrinkle does not lend itself to conventional 3D analysis measurements). This evaluation will be completed by a series of other dermatological explorations, also non-invasive: clinical scoring, measurement of skin hydration, elasticity, photographic evaluation of skin ageing and measurement of dermal density by high frequency ultrasound

Conditions

• Aging

Interventions

Type	Name	Description
DEVICE	injection	Intradermal injection on the face and neck/or décolleté by the NCTF135 HA
OTHER	Cream application	Application of hydra filler cream on the face and neck/or décolleté

Timeline

• Start date: 2019-06-11
• Primary completion: 2019-09-17
• Completion: 2019-11-07
• First posted: 2022-11-08
• Last updated: 2022-11-08

Locations

1 site across 1 country: France