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

NCT ID: NCT07344584

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-16
• Study Completion Date: 2027-06-30

Brief 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.

Conditions

Wrinkle Reduction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GP0122

Participants will receive GP0122 in the cheek area at baseline with an optional touch-up session 1 month after the initial session.

Group Type: ACTIVE_COMPARATOR

GP0122

Intervention Type: DEVICE

Injectable gel.

GP0124

Participants will receive GP0124 in the cheek area at baseline with an optional touch-up session 1 month after the initial session.

Group Type: ACTIVE_COMPARATOR

GP0124

Intervention Type: DEVICE

Injectable gel.

Interventions

GP0122

Injectable gel.

Intervention Type: DEVICE

GP0124

Injectable gel.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Galderma R&D

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Clinical Project Manager

Role: CONTACT

clinical.studies@galderma.com

8179615000 ext. +1

Other Identifiers

43CASH2210

Identifier Type: -

Identifier Source: org_study_id