Wrinkle ReductionNCT07344584
A Prospective Pilot Study to Evaluate Safety and Effectiveness of GP0122 and GP0124 for Correction of Lines and Wrinkles in the Cheek Area
A study testing GP0122 and GP0124 in people with Wrinkle Reduction, run by Galderma R&D at 5 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Wrinkle Reduction
- What is being tested?
- GP0122 and GP0124
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 5 sitesCanada
- Study dates
- 17 Feb 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
- 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.
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- 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.
- 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 locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
Galderma Investigational Site #8379
Burlington, L7N3N2
Galderma Investigational Site #8689
Toronto, M543N8
Galderma Investigational Site #8688
Vancouver, V5ZRE1
Galderma Investigational Site #7049
Vancouver, V6H4E1
Galderma Investigational Site #8162
Woodbridge, L4L 8E2
About this study
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.
- Conditions
- Wrinkle Reduction
- Being tested
- GP0122, GP0124
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GP0122Device
Injectable gel.
GP0124Device
Injectable gel.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: GP0122 |
| 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. Receives: Device: GP0124 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With all Adverse Events (AEs)
Measured: From Day 1 up to last visit (Up to 12 months)
Number of Participants With Post-Treatment Responses as Assessed Using Subject Diary Data
Measured: From Day 1 up to Day 28
Participant's Pain Assessment Using Numeric Pain Scale (NPS) Immediately Post Treatment and 30 Minutes Post Treatment
Measured: Immediately and 30 minutes after each treatment
Secondary outcomes (2)
Responder Rates Based on the Treating Investigator's Live Assessment of the GCWS at Rest at Months 3, 6, 9 and 12
Measured: 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
Measured: At Months 3, 6, 9 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start17 Feb 2026
- Primary completion30 May 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wrinkle ReductionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07344584
- Sponsor's protocol ID
- 43CASH2210
- Status last verified
- Aug 2026
- First submitted
- 7 Jan 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Pilot Study to Evaluate Safety and Effectiveness of GP0122 and GP0124 for Correction of Lines and Wrinkles in the Cheek Area
- ClinicalTrials.gov ID
- NCT07344584
- Acronym / sponsor ID
- 43CASH2210
- Conditions
- Wrinkle Reduction
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- 17 Feb 2026 (actual)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GP0122 | Active comparator | Device: GP0122Participants will receive GP0122 in the cheek area at baseline with an optional touch-up session 1 month after the initial session. |
| GP0124 | Active comparator | Device: GP0124Participants will receive GP0124 in the cheek area at baseline with an optional touch-up session 1 month after the initial session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (9 listed)
- 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.
- Presence of any disease or lesions in the treatment area.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GP0122Injectable gel. | Device | GP0122 |
| GP0124Injectable gel. | Device | GP0124 |
Primary outcome
Number of Participants With all Adverse Events (AEs)
Time frame: From Day 1 up to last visit (Up to 12 months)
Number of Participants With Post-Treatment Responses as Assessed Using Subject Diary Data
Time frame: From Day 1 up to Day 28
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
2 secondary outcomes
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GP0122 and GP0124 in people with Wrinkle Reduction, run by Galderma R&D at 5 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With all Adverse Events (AEs) (time frame: From Day 1 up to last visit (Up to 12 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.