A Prospective Pilot Study to Evaluate Safety and Effectiveness of GP0122 and GP0124 for Correctio… (NCT07344584) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Prospective Pilot Study to Evaluate Safety and Effectiveness of GP0122 and GP0124 for Correction of Lines and Wrinkles in the Cheek Area
60 participantsStarted 2026-01-16
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. Negative UPT at the screening and baseline visits.
Exclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With all Adverse Events (AEs)
Timeframe: 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
Timeframe: 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
Timeframe: Immediately and 30 minutes after each treatment
. Presence of any disease or lesions in the treatment area.
. An underlying known disease, a surgical or medical condition that would expose the participant to undue risk.
. Use of concomitant medication that have the potential to prolong bleeding times.
. Presence of any condition or situation, which in the opinion of the Treating Investigator makes the subject unable to complete the study per protocol.