A Prospective Pilot Study to Evaluate Safety and Effectiveness of GP0122 and GP0124 for Correction of Lines and Wrinkles in the Cheek Area

NCT07344584•Galderma R&D

Summary

The primary objective of the study is to evaluate the safety of GP0122 and GP0124 for the correction of lines and wrinkles in the cheek area.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Participants with a GCWS At Rest score of Moderate or Severe on EACH side of the face, or Participants with a CSQS-CL score of Moderate, Severe, or Very severe on EACH side of the face.
•2. Intent to undergo treatment for correction of lines and wrinkles in the cheek region.
•3. Willing to abstain from any other facial plastic, surgical or cosmetic procedures in the cheek area for the duration of the study (e.g., laser or chemical resurfacing, needling, facelift, lifting threads, radiofrequency etc.).
•4. Agrees to use an acceptable form of effective birth control for the duration of the study and is willing to take a urine pregnancy test (UPT) at screening, baseline and prior to receiving any study treatment.
•5. Negative UPT at the screening and baseline visits.

Exclusion Criteria

•1. Known/previous allergy or hypersensitivity.
•2. Known/previous allergy or hypersensitivity to local anesthetics.
•3. Previous facial surgery (e.g., facelift) in the treatment area that in the Treating Investigator´s opinion.
•4. Any previous aesthetic procedures or implants in the treatment area.
•5. Presence of any disease or lesions in the treatment area.
•6. An underlying known disease, a surgical or medical condition that would expose the participant to undue risk.
•7. Use of concomitant medication that have the potential to prolong bleeding times.
•8. Presence of any condition or situation, which in the opinion of the Treating Investigator makes the subject unable to complete the study per protocol.
•9. Women who are pregnant or breast feeding, or women of childbearing potential who are not practicing adequate contraception or planning to become pregnant during the study period.

Key Dates

Start Date

January 16, 2026

Primary Completion Date

April 30, 2027

Completion Date

June 30, 2027

Last Updated

January 15, 2026

Enrollment

ESTIMATED participants

Conditions

Wrinkle Reduction

Interventions

GP0122

DEVICE

GP0124

DEVICE

Contacts

Clinical Project Manager

CONTACT

8179615000 clinical.studies@galderma.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 15, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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