Clinical trial NCT05098457: Safety and Effectiveness of GP0112 for Cheek Augmentation and Correction
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cheek Wrinkles
Midface Contour Deficiencies
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2021-10-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

1. 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.
2. Men and non-pregnant, non-breastfeeding women aged 18 years or older.
3. 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.
4. 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.).
5. Intent to undergo treatment for correction of midface volume deficit.

   Inclusion criteria 6-7 apply to female subjects only
6. 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.
7. Negative UPT for women of childbearing potential at the screening/baseline visit and all injection visits.

Exclusion Criteria:

1. Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel or to gram positive bacterial proteins.
2. 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).
3. Previous or present severe or multiple allergies manifested by severe reactions, such as anaphylaxis or angioedema, or family history of these conditions.
4. 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.
5. 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.
   * 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.
6. History of cancer or previous radiation near or on the area to be treated.
7. 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).
8. 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.
9. 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.
10. 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.
11. 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.
12. 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.
13. Treatment with chemotherapy, immunosuppressive agents, immunomodulatory therapy (e.g. immunosuppressive monoclonal antibodies, antiviral treatment for HIV or hepatitis).
14. Treatment with systemic corticosteroids (inhaled corticosteroids are allowed) within 3 months prior to Baseline visit.
15. 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.
16. 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.
17. 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.
18. 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.
19. Participation in any other interventional clinical study within 30 days before treatment.

Primary outcomes:
measure: Demonstrate non-inferiority of GP0112 versus a comparator-control in cheek augmentation and correction of midface contour deficiencies
timeFrame: 3 Months
Secondary outcomes:
measure: Effectiveness of GP0112 and comparator-control based on the Medicis Midface Volume Scale (MMVS) assessment
timeFrame: 6, 9, 12 and 13 Months
measure: Effectiveness of GP0112 on the Global Aesthetic Improvement Scale (GAIS)
timeFrame: 3, 6, 9, 12 and 13 Months
measure: Effectiveness of GP0112 and comparator-control using the FACE-Q
timeFrame: 3, 6, 9, 12 and 13 Months
measure: Effectiveness of GP0112 and comparator-control using Subject Satisfaction Questionnaire
timeFrame: 3, 6, 9, 12 and 13 Months
measure: Effectiveness of GP0112 and comparator-control in returning to social engagement
timeFrame: 3, 6, 9, 12 and 13 Months
measure: Safety of GP0112 in cheek augmentation and correction of midface contour deficiencies adverse events (AEs)
timeFrame: Up to 13 Months
measure: Safety of GP0112 in cheek augmentation and correction of midface contour pre-defined expected post-treatment events
timeFrame: Up to 13 Months
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: Galderma Research Site
city: Darmstadt
country: Germany
facility: Galderma Research Site
city: Duesseldorf
country: Germany
facility: Galderma Research Site
city: Duesseldorf
country: Germany
facility: Galderma Research Site
city: Hamburg
country: Germany
facility: Galderma Research Site
city: Hamburg
country: Germany
facility: Galderma Research Site
city: Munich
country: Germany
facility: Galderma Research Site
city: Wuppertal
country: Germany
facility: Galderma Research Site
Study officials:
affiliation: Galderma R&D
name: Study Director
role: STUDY_DIRECTOR
References: