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
This trial accepts healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
GP0122
DeviceInjectable gel.
GP0124
DeviceInjectable gel.
Treatment groups
Trial outcomes
Primary outcomes
Number of Participants With all Adverse Events (AEs)
Number of Participants With Post-Treatment Responses as Assessed Using Subject Diary Data
Participant's Pain Assessment Using Numeric Pain Scale (NPS) Immediately Post Treatment and 30 Minutes Post Treatment
Secondary outcomes
Responder Rates Based on the Treating Investigator's Live Assessment of the GCWS at Rest 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
Locations
Sponsors and contacts
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