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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGalderma R&D

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • GP0122
  • GP0124

Treatment groups

60 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators