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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Wrinkle Reduction
• Intervention / Treatment: Device: GP0122; Device: GP0124

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clinical Project Manager; Phone Number: +1 8179615000; Email: clinical.studies@galderma.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria: Adult males or non-pregnant, non-breastfeeding adult females.

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.).

   Inclusion criteria 4-5 apply only to female participants of childbearing potential:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: GP0122; Participants will receive GP0122 in the cheek area at baseline with an optional touch-up session 1 month after the initial session.	Device: GP0122; Injectable gel.
Active Comparator: GP0124; Participants will receive GP0124 in the cheek area at baseline with an optional touch-up session 1 month after the initial session.	Device: GP0124; Injectable gel.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Galderma R&D

Study record dates

Study Major Dates

• Study Start (Estimated): January 16, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: January 7, 2026
• First Submitted That Met QC Criteria: January 7, 2026
• First Posted (Actual): January 15, 2026

Study Record Updates

• Last Update Posted (Actual): January 15, 2026
• Last Update Submitted That Met QC Criteria: January 7, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 43CASH2210

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No