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Active, Not Recruiting

NCT Number: NCT07145905

TCRM for Correction of Cheek Including Fine Lines

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro Médico Lajo Rosso

Madrid, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TCRM

Device

N=128

Primary outcomes

  1. 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.

    Time frame: 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"

Sponsors and collaborators

Lead sponsor

Teoxane SA

Industry

Registry information

Official study title

A Prospective, Open-label, Multicenter, Interventional Study, to Evaluate Safety and Efficacy of TCRM in the Treatment of the Cheek Area Including Fine Lines: SPARKS

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Aug 28, 2025
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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