Not Yet RecruitingNot Applicable

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

60 participantsStarted 2026-01-16

Plain-language 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.

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.

Number of Participants With all Adverse Events (AEs)

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

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

Timeframe: From Day 1 up to Day 28

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

Timeframe: Immediately and 30 minutes after each treatment

NCT IDNCT07344584

SponsorGalderma R&D

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-04-30

Clinical Project Manager

Who can participate