TCRM for Correction of Cheek Including Fine Lines

Teoxane

Status: Active, not recruiting

Conditions: Cheek Wrinkles; Skin Aging

Treatments: Device: TCRM

Study type: Interventional

Funder types: Industry

Identifiers

NCT07145905

TEO-TCRM-2204

Details and patient eligibility

About

The purpose of this clinical study is to evaluate benefits and risks of injecting TCRM in the cheek including fine lines. The goal is to show that treatment with TCRM will result in correcting the cheek area including the fine lines at 4 weeks after last treatment (initial injection or touch up) on subjects.

Enrollment: 130 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy adult subjects over 18 years old seeking correction of the cheek area including fine lines.
• Subject scored grade 1 to 3 on the CFLDS.
• For women: not pregnant, not breast feeding
• Female subjects of childbearing potential must have a negative UPT and practice a reliable method of contraception throughout the study.
• Willing to abstain from facial aesthetic procedures/therapies that could interfere with study evaluations
• Able to follow study instructions and complete all required visits.
• Having given its signed informed consent.

Exclusion criteria

• Known hypersensitivity or previous allergic reaction to any component of the study devices
• Known sensitivity to local anesthetics of the amide type, history of multiple severe allergies, or history of anaphylactic shock.
• History of active chronic debilitating systemic disease that, in the opinion of the investigator, would make the subject a poor candidate in the study.
• Subject exhibits any physical attribute that may prevent assessment or treatment of the cheek area including fine lines as judged by the PI
• Clinically significant alcohol or drug abuse.
• Subject has received any investigational product within 90 days prior to Visit 1 or planning to participate in another investigation during the course of the study.
• Subject has unstable weight, as judged by the PI.
• Subject has no teeth or misses significant portion of dentition that changes the face appearance (subjects with dentures sufficiently replacing missing natural teeth are allowed).
• Subject under guardianship/tutorship

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

130 participants in 1 patient group

TCRM

Experimental group

Description:

Treatments performed in this study include: * An initial injection at V1 during which subjects will be injected with TCRM in the cheek area. * An optional touch-up injection 4 weeks after the initial injection (at V2).

Treatment:

Device: TCRM