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Cheek WrinklesNCT05262777

Safety and Effectiveness of GP0112 for Cheek Augmentation and Correction of Midface Contour Deficiencies

A study testing GP0112 and Restylane Lyft Lidocaine in people with Cheek Wrinkles and Midface Contour Deficiencies, run by Galderma R&D at 15 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A randomized, evaluator-blinded, parallel group, comparator-controlled, multicenter study to evaluate the safety and effectiveness of GP0112 for cheek augmentation and correction of midface contour deficiencies Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Cheek Wrinkles, Midface Contour Deficiencies
What is being tested?
GP0112 and Restylane Lyft Lidocaine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
211 participants
Where
15 sitesCanada
Study dates
2 May 2022to 5 Mar 2024
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Ability to adequately understand the verbal explanations and the written subject information provided in local language and ability and willingness to give consent to participate in the study. Signed and dated informed consent to participate in the study.
  • Men and non-pregnant, non-breastfeeding women aged 18 years or older.
  • MMVS grade of 2, 3 or 4 (mild to substantial loss of fullness in the midface area) on each side of the face as assessed by the Blinded Evaluator. The MMVS for each side of the face does not need to be equal, however the difference between the two sides should be limited to 1 grade.
  • Subjects willing to abstain from any other facial plastic surgical or cosmetic procedures below the level of the lower orbital rim for the duration of the study (e.g., laser or chemical resurfacing, needling, facelift, lifting threads, radiofrequency etc.).
  • Intent to undergo treatment for correction of midface volume deficit.
  • If the subject is a female of childbearing potential, she 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 the screening/baseline visit, prior to treatment/injection, and at the end of study visit.
  • Negative UPT for women of childbearing potential at the screening/baseline visit and all injection visits.

Who cannot join

  • Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel or to gram positive bacterial proteins.
  • Known/previous allergy or hypersensitivity to local anesthetics, e.g. lidocaine or other amide-type anesthetics or nerve blocking agents (if intended to be used for that subject).
  • Previous or present severe or multiple allergies manifested by severe reactions, such as anaphylaxis or angioedema, or family history of these conditions.
  • Previous facial surgery (e.g. facial fat removal, facelift and sinus surgery) in or near the treatment area that in the Treating Investigator´s opinion could interfere with the study safety and/or effectiveness assessments.
  • Any previous aesthetic procedures or implants:
  • Previous use of any permanent (non-biodegradable) or semi-permanent (e.g., calcium hydroxylapatite or Poly-L-Lactic acid) facial tissue augmentation therapy, lifting threads, permanent implants or autologous fat in the face regardless of time.
Show all 33Show fewer
  • Previous HA filler or collagen filler in or near the treatment area within 12 months.
  • Previous botulinum toxin treatment in or near the treatment area within 6 months.
  • Previous energy based aesthetic procedures (e.g. laser, intense pulsed light, radiofrequency and ultrasound) in or near the treatment area within 6 months.
  • Previous mechanical (e.g. dermabrasion, needling) or chemical aesthetic procedures (e.g. chemical peel) in or near the treatment area within 6 months.
  • Previous treatment with cryotherapy in or near the treatment area within 6 months.
  • History of cancer or previous radiation near or on the area to be treated.
  • Presence of any disease or lesions near or on the area to be treated, e.g.,
  • Inflammation, active or chronic infection (e.g., in mouth, dentals, head);
  • Facial psoriasis, eczema, acne, rosacea, perioral dermatitis, herpes simplex or herpes zoster;
  • Scars or deformities;
  • Cancer, or precancerous conditions (e.g. actinic keratosis or actinic cheilitis).
  • Evidence of scar-related disease or delayed healing activity within 1 year prior to the baseline visit, or subjects susceptible to keloid formation, hyperpigmentation or hypertrophic scarring.
  • Presence of tattoo, piercing, beard or facial hair, which, in the Treating Investigator's opinion, would interfere with the study injections and/or study assessment.
  • Presence of a dental, oral, or facial condition which, in the Treating Investigator's opinion, would interfere with the study injections and/or study assessment; e.g. has dentures or any device covering all or part of the upper palate, and/or severe malocclusion or dentofacial or maxillofacial deformities. Any planned procedure (e.g. dental implants, tooth extractions, orthodontia) during the study period, that would make the subject unsuitable for inclusion in the opinion of the Investigator.
  • An underlying known disease, a surgical or medical condition that would expose the subject to undue risk, e.g. human immunodeficiency virus (HIV), active hepatitis, autoimmune disease, history of bleeding disorders, connective tissue diseases such as rheumatoid arthritis, systemic lupus erythematosus, polymyositis, dermatomyositis, or scleroderma.
  • Use of concomitant medication that have the potential to prolong bleeding times such as anticoagulants or inhibitors of platelet aggregation (e.g. aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs), Omega 3 or Vitamin E), within 14 days prior to injection. Omega 3 and Vitamin E are acceptable only as part of a standard multivitamin formulation.
  • Treatment with chemotherapy, immunosuppressive agents, immunomodulatory therapy (e.g. immunosuppressive monoclonal antibodies, antiviral treatment for HIV or hepatitis).
  • Treatment with systemic corticosteroids (inhaled corticosteroids are allowed) within 3 months prior to Baseline visit.
  • Use of topical facial corticosteroids or prescription retinoids near or on the area to be treated within 1 month of the Baseline visit or systemic retinoid treatment within 6 months of the Baseline visit, or plan to receive such treatment during participation in the study.
  • Presence of any condition or situation, which in the opinion of the Treating Investigator makes the subject unable to complete the study per protocol, e.g.
  • Subject is not likely to avoid other prohibited facial cosmetic treatments;
  • Subject is not likely to complete the study because of other commitments;
  • Subject is anticipated to be unavailable for visits, incapable of understanding the investigational assessments or having unrealistic expectations of treatment result;
  • Subject who has a concomitant condition (e.g. acute viral or bacterial infection with fever) that might confuse or confound study treatments or assessments.
  • Subject who plan to lose or has a medical condition that may cause them to lose a significant amount of weight during the course of the study.
  • Study center personnel, close relatives of the study center personnel (e.g. parents, children, siblings, or spouse), employees or close relatives of employees at the Sponsor company.
  • Participation in any other interventional clinical study within 30 days before treatment.

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

Canada15 sites

  • Galderma Research Site

    Calgary, Alberta, T3E 0B2

  • Galderma Research Site

    Edmonton, Alberta, T5J 3S9

  • Galderma Research Site

    Edmonton, Alberta, T6G 1C3

  • Galderma Research Site

    Montreal, Quebec, H2X 2V1

  • Galderma Research Site

    Oakville, Ontario, L6J 7W5

  • Galderma Research Site

    Richmond Hill, Ontario, L4B 1A5

  • Galderma Research Site

    Toronto, Ontario, M3H 5Y8

  • Galderma Research Site

    Toronto, Ontario, M4W 2N4

  • Galderma Research Site

    Toronto, Ontario, M5R 3N8

  • Galderma Research Site

    Vancouver, British Columbia, V5Z 4E1

  • Galderma Research Site

    Vancouver, British Columbia, V6H 1K9

  • Galderma Research Site

    Vancouver, British Columbia, V6H 4E1

  • Galderma Research Site

    Windsor, Ontario, N8W 5L7

  • Galderma Research Site

    Winnipeg, Manitoba, R3M 3Z4

  • Galderma Research Site

    Woodbridge, Ontario, L4L 8E2

Other trials in Canada

About this study

Official title: A Randomized, Evaluator-blinded, Parallel Group, Comparator-controlled, Multicenter Study to Evaluate the Safety and Effectiveness of GP0112 for Cheek Augmentation and Correction of Midface Contour Deficiencies

A randomized, evaluator-blinded, parallel group, comparator-controlled, multicenter study to evaluate the safety and effectiveness of GP0112 for cheek augmentation and correction of midface contour deficiencies

Being tested
GP0112, Restylane Lyft Lidocaine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GP0112Device

    Injectable gel

  • Restylane Lyft LidocaineDevice

    Injectable gel

Study groups in NCT05262777
Study groupRoleWhat they receive
GP0112ExperimentalGP0112 Single injection and optional touch up injection and re-treatment with GP0112
Receives: Device: GP0112
Restylane Lyft LidocaineActive comparatorRestylane Lyft Lidocaine Single injection and optional touch up injection and re-treatment with Restylane Lyft Lidocaine
Receives: Device: Restylane Lyft Lidocaine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Demonstrate non-inferiority of GP0112 versus a comparator-control in cheek augmentation and correction of midface contour deficiencies

    Investigator's and Blinded Evaluator's live assessment on validated 4-grade photographic Medicis Midface Volume Scale (MMVS) to rate the subject's right and left midface separately for severity of volume deficiency. The change from baseline at Month 3 will be the response variable

    Measured: 3 Months

Secondary outcomes (7)

  1. Effectiveness of GP0112 and comparator-control based on the validated 4-grade Medicis Midface Volume Scale (MMVS) assessment

    Responder rate based on the Blinded Evaluator's live assessment of the validated 4-grade Medicis Midface Volume Scale (MMVS). A responder is defined as a subject with at least 1 grade improvement from baseline on both sides of the face concurrently

    Measured: 3, 6, 9, 12, 15, 18 and 19 Months

  2. Effectiveness of GP0112 on the Global Aesthetic Improvement Scale (GAIS)

    Percentage of responders, defined by having at least "Improved" (improved, much improved or very much improved) on the Global Aesthetic Improvement Scale (GAIS) by the subject and treating investigator

    Measured: 3, 6, 9, 12, 15, 18 and 19 Months

  3. Effectiveness of GP0112 and comparator-control using the FACE-Q

    Change from baseline in FACE-Q Satisfaction with Cheeks Rasch transformed total score, as well as proportion of subjects in each response category for each of the individual questions for the FACE-Q Satisfaction with Cheeks and Satisfaction with Outcome questionnaires

    Measured: 3, 6, 9, 12, 15, 18 and 19 Months

  4. Effectiveness of GP0112 and comparator-control using Subject Satisfaction Questionnaire (SSQ)

    Proportion of subjects in each response category (strongly agree, agree, neutral, disagree or strongly disagree) for every question in the Subject Satisfaction Questionnaire (SSQ)

    Measured: 3, 6, 9, 12, 15,18 and 19 Months

  5. Effectiveness of GP0112 and comparator-control in returning to social engagement

    Time in hours until the subject feels comfortable returning to social engagement after treatment, based on subject diary reporting

    Measured: 3, 6, 9, 12, 15,18 and 19 Months

  6. Safety of GP0112 in cheek augmentation and correction of midface contour deficiencies adverse events (AEs)

    Incidence, intensity, time to onset and duration of adverse events

    Measured: Up to 19 Months

  7. Safety of GP0112 in cheek augmentation and correction of midface contour pre-defined expected post-treatment events

    Incidence, intensity and number of days of pre-defined expected post-treatment events collected using subject diaries for 28 days following each treatment

    Measured: Up to 19 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2022
  2. Study start2 May 2022
  3. Primary completion17 Jan 2023
  4. Study completion5 Mar 2024

Resources

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
211 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05262777
Sponsor's protocol ID
43N1CA2104
Status last verified
Apr 2024
First submitted
10 Feb 2022
Last updated
9 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing GP0112 and Restylane Lyft Lidocaine in people with Cheek Wrinkles and Midface Contour Deficiencies, run by Galderma R&D at 15 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 7 inclusion and 33 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 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 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?

Demonstrate non-inferiority of GP0112 versus a comparator-control in cheek augmentation and correction of midface contour deficiencies (time frame: 3 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05262777.

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 9 Apr 2024.

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