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

Galderma

Status: Not yet enrolling

Conditions: Wrinkle Reduction

Treatments: Device: GP0122; Device: GP0124

Study type: Interventional

Funder types: Industry

Identifiers

NCT07344584

43CASH2210

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

GP0122

Active Comparator group

Description:

Participants will receive GP0122 in the cheek area at baseline with an optional touch-up session 1 month after the initial session.

Treatment:

Device: GP0122

GP0124

Active Comparator group

Description:

Participants will receive GP0124 in the cheek area at baseline with an optional touch-up session 1 month after the initial session.

Treatment:

Device: GP0124