Chin Augmentation and CorrectionNCT04631263
New Dermal Filler for Chin Correction and Augmentation
A study testing Hyaluronic Acid in people with Chin Augmentation and Correction, run by Galderma R&D at 9 sites in Canada.
Trial summary
Randomized, evaluator-blinded, no treatment controlled multicenter study to evaluate safety and effectiveness of GP0109 for augmentation and correction or retrusion in the chin region in Canada Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chin Augmentation and Correction
- What is being tested?
- Hyaluronic Acid
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 9 sitesCanada
- Study dates
- 29 Jan 2021to 16 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- subject willing to comply with the requirements of the study
- subject intent to receive treatment for augmentation and correction of retrusion in the chin region
- subject with mild or moderate (grade 1 or 2) on the GCRS
Who cannot join
- subjects presenting with know allergy to HA (hyaluronic acid) filler or amide local anesthetics
- subjects with any previous facial surgery below the nasal line or previous HA filler or collagen below the nasal line within 12 months
- subjects in any other interventional clinical study within 30 days before baseline
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Canada9 sites
Galderma Research Site
Burlington, Ontario, L7N3N2
Galderma Research Site
Calgary, Alberta, T3E0B2
Galderma Research Site
Toronto, Ontario, M5R3N8
Galderma Research Site
Toronto, Ontario, M5X1A9
Galderma Research Site
Vancouver, British Columbia, V5Z4E1
Galderma Research Site
Vancouver, British Columbia, V6H1K9
Galderma Research Site
Vancouver, British Columbia, V6H4E1
Galderma Research Site
Westmount, Quebec, H3Z1C3
Galderma Research Site
Woodbridge, Ontario, L4L8E2
About this study
Official title: A Randomized, Evaluator-blinded, Parallel Group, no Treatment Controlled, Multi-center Study to Evaluate Effectiveness and Safety of GP0109 for Augmentation and Correction of Retrusion in the Chin Region
Randomized, evaluator-blinded, no treatment controlled multicenter study to evaluate safety and effectiveness of GP0109 for augmentation and correction or retrusion in the chin region in Canada
- Conditions
- Chin Augmentation and Correction
- Being tested
- Hyaluronic Acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic AcidDevice
Also called GP0109
Injectable gel. Chin correction and augmentation for retrusion
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Not described Receives: Device: Hyaluronic Acid |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responder rate based on the Galderma Chin Retrusion Scale as assessed live by the Blinded Evaluator
Measured: 3 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start29 Jan 2021
- Primary completion9 Sep 2021
- Study completion16 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chin Augmentation and CorrectionStudies of the same condition, open and under way.
- More trials run by Galderma R&DThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Galderma R&D
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04631263
- Sponsor's protocol ID
- 43BBJ2001
- Status last verified
- Jun 2022
- First submitted
- 10 Nov 2020
- Last updated
- 25 Aug 2022
- 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 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Evaluator-blinded, Parallel Group, no Treatment Controlled, Multi-center Study to Evaluate Effectiveness and Safety of GP0109 for Augmentation and Correction of Retrusion in the Chin Region
- ClinicalTrials.gov ID
- NCT04631263
- Acronym / sponsor ID
- 43BBJ2001
- Conditions
- Chin Augmentation and Correction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- 29 Jan 2021 (actual)
- Primary completion
- 9 Sep 2021 (actual)
- Study completion
- 16 Jun 2022 (actual)
- First posted
- 17 Nov 2020 (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.
Randomized, evaluator-blinded, no treatment controlled multicenter study to evaluate safety and effectiveness of GP0109 for augmentation and correction or retrusion in the chin region in Canada
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: Hyaluronic Acid |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- subject willing to comply with the requirements of the study
- subject intent to receive treatment for augmentation and correction of retrusion in the chin region
- subject with mild or moderate (grade 1 or 2) on the GCRS
Key exclusion criteria (3 listed)
- subjects presenting with know allergy to HA (hyaluronic acid) filler or amide local anesthetics
- subjects with any previous facial surgery below the nasal line or previous HA filler or collagen below the nasal line within 12 months
- subjects in any other interventional clinical study within 30 days before baseline
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 |
|---|---|---|
| Hyaluronic AcidAlso: GP0109Injectable gel. Chin correction and augmentation for retrusion | Device | Treatment Group |
Primary outcome
Responder rate based on the Galderma Chin Retrusion Scale as assessed live by the Blinded Evaluator
Time frame: 3 months after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2022.
- Individual participant dataSharing planned: No
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.
Study Director study director
Galderma R&D
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyaluronic Acid in people with Chin Augmentation and Correction, run by Galderma R&D at 9 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 25 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Responder rate based on the Galderma Chin Retrusion Scale as assessed live by the Blinded Evaluator (time frame: 3 months after baseline). 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 25 Aug 2022.