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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GP0122 | Device | Injectable gel. |
| |
| GP0124 |
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria: Adult males or non-pregnant, non-breastfeeding adult females.
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.).
Inclusion criteria 4-5 apply only to female participants of childbearing potential:
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.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Manager | Contact | 8179615000 | +1 | clinical.studies@galderma.com |
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| Device |
Injectable gel. |
|
| At Months 3, 6, 9 and 12 |