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

NCT05609617 | Completed

• 2 other identifiers: HEBE2: 2018-A03167-482018-A03167-48
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Aging

Outcome Measures

Primary Outcomes (1)

• Change from Baseline of the mean volume of crow's feet wrinkles for the face at Day 75

  Change from Baseline of the mean volume of crow's feet wrinkles for the face at Day 75 e (depth and surface) in mm\^3 measured by LifeViz 3D micro® of injected group compared to control group

  Day 75 (75 days after the injection

Study Arms (4)

Face and neck injection

EXPERIMENTAL

NCTF135HA intradermal injection on face and neck. 3 injections spaced out by two weeks; injection points are spaced every 1-1.5 cm with a quantity of 0.05 ml on each point. Application of Hydra Filler cream twice daily on the face and neck.

Device: injection

Face and upper chest/décolleté injection

EXPERIMENTAL

NCTF135HA intradermal injection on face and décolleté. 3 injections spaced out by two weeks; injection points are spaced every 1-1.5 cm with a quantity of 0.05 ml on each point. Application of Hydra Filler cream twice daily on the face and décolleté.

Device: injection

Face and neck controle

ACTIVE COMPARATOR

Application of Hydra Filler cream twice daily on the face and neck.

Other: Cream application

Face and upper chest/décolleté controle

ACTIVE COMPARATOR

Application of Hydra Filler cream twice daily on the face and décolleté.

Other: Cream application

Interventions

injection DEVICE

Intradermal injection on the face and neck/or décolleté by the NCTF135 HA

Face and neck injection; Face and upper chest/décolleté injection

Cream application OTHER

Application of hydra filler cream on the face and neck/or décolleté

Face and neck controle; Face and upper chest/décolleté controle

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects ≥19 years old;
• Subject who has signed a written informed consent;
• Subject with a Fitzpatrick phototype of I, II, III or IV
• Subject with a grade of photoaging of 2 or 3 on a scale of Glogau
• Subject having a wrinkle score according to Lemperle scale of 2, 3 or 4 at the level of periorbital lines
• Subject having at least:
• a Grade 1, 2, 3 or 4 on Bazin Neck Wrinkle Scale (at least N=30 subject for the control group)
• or a Grade 2, 3 or 4 on Landau Décolleté Wrinkle Scale (at least N=30 subject for the control group)
• Subject registered in social security system or other health insurance regimen
• Subject accepting not to expose Him/herself to the sun or ultraviolet (UV) during the entire duration of the study.
• Female subject accepting to take a pregnancy test.

You may not qualify if:

• Subject deprived of freedom by an administrative or legal decision
• Unable to follow protocol requirements.
• Subject who has received indemnification of 4500 € during the 12 previous months for his/her participation in clinical trials (including participation in this study).
• Subject having benefited from injection/facial implantation of any non-absorbable filling agent at any time of his/her life.
• Subject having already had laser sessions for skin rejuvenation or a laser facelift in the previous year or a facelift by surgery in the 2 years prior to the study.
• Subject with a history of fillers injections (hyaluronic acid type) in the last year or botulinum toxin in the last 6 months or the injectable implants (semi-permanent fillers) in the last two years.
• Subject with a skin support device (wire mesh, gold wire, liquid silicone or other particulate material) at the study zones.
• Subject having done a moderate to deep peeling or non-invasive rejuvenation techniques such as radiofrequency, ultrasound and lasers in the last 6 months.
• Subject with a history of multiple severe allergies or anaphylactic shock.
• Subject with a known hypersensitivity to hyaluronic acid, or other components of the NCTF 135HA solution.
• Subject with known intolerance/hypersensitivity to any cosmetic topical products, hyaluronic acid and/or other components of Hydra-Filler ® FILORGA Moisturizing Cream.
• Subject with a known hypersensitivity to chlorhexidine.
• Subject with a known hypersensitivity to lidocaine or to local amide-type anesthetics
• Prone to developing inflammatory skin conditions or hypertrophic scarring according to investigator judgement.
• Subject with a history of streptococcal diseases (angina recurrent, rheumatic fever).

Sponsors & Collaborators

• Laboratoires FILLMED: lead

Study Sites (1)

Dr Jean-Jacques DEUTSCH

Paris, 75008, France

Location

Related Publications (1)

• Fanian F, Deutsch JJ, Bousquet MT, Boisnic S, Andre P, Catoni I, Beilin G, Lemmel C, Taieb M, Gomel-Toledano M, Issa H, Garcia P. A hyaluronic acid-based micro-filler improves superficial wrinkles and skin quality: a randomized prospective controlled multicenter study. J Dermatolog Treat. 2023 Dec;34(1):2216323. doi: 10.1080/09546634.2023.2216323. Epub 2023 Aug 14.

  PMID: 37577796 DERIVED

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 145 subjects divided into 2 groups (Randomization 3:1 for the face): • 107 subjects in treatment group on the face. Among these patients, N=55 were injected on the neck and N=49 on the décolleté. 38 patients were included in the control group. Among these patients, all were studied on the neck and N=34 were studied on the décolleté

Study Record Dates

• First Submitted: October 20, 2022
• First Posted: November 8, 2022
• Study Start: June 11, 2019
• Primary Completion: September 17, 2019
• Study Completion: November 7, 2019
• Last Updated: November 8, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)