Cheek Wrinkles, Skin Aging
Conditions
Brief summary
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.
Interventions
DEVICETCRM
N=128
Sponsors
Teoxane SA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To demonstrate the efficacy of TCRM in the treatment of the cheek area including fine lines at 4 weeks after last injection (initial injection or touch up) using Global Aesthetic Improvement Scale (GAIS) as assessed by both subject and PI. | 4 weeks after last injection | The Global Aesthetic Improvement (GAI) is a subjective, balanced, 5-point dynamic scale assessing cosmetic improvement. Possible scores range from much improved, improved, no change, worse, to much worse |
Countries
Spain
Outcome results
None listed