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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • GP0122

    Device

    Injectable gel.

  • GP0124

    Device

    Injectable gel.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: GP0122Active comparator 1 intervention
Group B: GP0124Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of Participants With all Adverse Events (AEs)

Time frame
From Day 1 up to last visit (Up to 12 months)
2

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

Time frame
From Day 1 up to Day 28
3

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

Time frame
Immediately and 30 minutes after each treatment

Secondary outcomes

1

Responder Rates Based on the Treating Investigator's Live Assessment of the GCWS at Rest at Months 3, 6, 9 and 12

Time frame
At Months 3, 6, 9 and 12
2

Responder Rates Based on the Treating Investigator's Live Assessment of the CSQS-CL at Rest at Months 3, 6, 9 and 12

Time frame
At Months 3, 6, 9 and 12

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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