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

NCT07344584 | Not Yet Recruiting

• 1 other identifier: 43CASH2210
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (3)

• Number of Participants With all Adverse Events (AEs)

  From Day 1 up to last visit (Up to 12 months)

• Number of Participants With Post-Treatment Responses as Assessed Using Subject Diary Data

  From Day 1 up to Day 28

• Participant's Pain Assessment Using Numeric Pain Scale (NPS) Immediately Post Treatment and 30 Minutes Post Treatment

  Immediately and 30 minutes after each treatment

Secondary Outcomes (2)

• Responder Rates Based on the Treating Investigator's Live Assessment of the GCWS at Rest at Months 3, 6, 9 and 12

  At Months 3, 6, 9 and 12

• Responder Rates Based on the Treating Investigator's Live Assessment of the CSQS-CL at Rest at Months 3, 6, 9 and 12

  At Months 3, 6, 9 and 12

Study Arms (2)

GP0122

ACTIVE COMPARATOR

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

Device: GP0122

GP0124

ACTIVE COMPARATOR

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

Device: GP0124

Interventions

GP0122 DEVICE

Injectable gel.

GP0122

GP0124 DEVICE

Injectable gel.

GP0124

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Intent to undergo treatment for correction of lines and wrinkles in the cheek region.
• 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.).
• 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.
• Negative UPT at the screening and baseline visits.

You may not qualify if:

• Known/previous allergy or hypersensitivity.
• Known/previous allergy or hypersensitivity to local anesthetics.
• Previous facial surgery (e.g., facelift) in the treatment area that in the Treating Investigator´s opinion.
• Any previous aesthetic procedures or implants in the treatment area.
• Presence of any disease or lesions in the treatment area.
• An underlying known disease, a surgical or medical condition that would expose the participant to undue risk.
• Use of concomitant medication that have the potential to prolong bleeding times.
• Presence of any condition or situation, which in the opinion of the Treating Investigator makes the subject unable to complete the study per protocol.
• 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.

Sponsors & Collaborators

• Galderma R&D: lead

Central Study Contacts

Clinical Project Manager

CONTACT

8179615000; clinical.studies@galderma.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: January 15, 2026
• Study Start: January 16, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share