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Active, not recruiting Not applicable

TCRM for Correction of Cheek Including Fine Lines

NCT07145905 · tracked via the Priya Life Science Spain tracker
Sponsor
Phase
Not applicable
Started
2023-11-30
Last updated
2025-09-08

Condition(s) studied

Skin AgingCheek Wrinkles

Investigational drug(s) / intervention(s)

TCRM

TCRM: N=128

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • 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"

Trial sites (1)

FacilityCityRegionStatus
Centro Médico Lajo Rosso Madrid Spain
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07145905 on ClinicalTrials.gov ↗ ← All trials in Spain