Safety and Effectiveness of GP0112 for Cheek Augmentation and Correction

NCT05098457 | Withdrawn

• 1 other identifier: 43N1EU2008
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 8

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

Conditions

Cheek Wrinkles; Midface Contour Deficiencies

Outcome Measures

Primary Outcomes (1)

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

  Change from baseline based on the Blinded Evaluator's live assessment of midface fullness using the 4-grade photograph-based Medicis Midface Volume Scale (MMVS)

  3 Months

Secondary Outcomes (7)

• Effectiveness of GP0112 and comparator-control based on the Medicis Midface Volume Scale (MMVS) assessment

  6, 9, 12 and 13 Months

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

  3, 6, 9, 12 and 13 Months

• Effectiveness of GP0112 and comparator-control using the FACE-Q

  3, 6, 9, 12 and 13 Months

• Effectiveness of GP0112 and comparator-control using Subject Satisfaction Questionnaire

  3, 6, 9, 12 and 13 Months

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

  3, 6, 9, 12 and 13 Months

Study Arms (2)

GP0112

EXPERIMENTAL

Single injection and optional touch up injection with GP0112

Device: GP0112

Restylane Lyft Lidocaine

ACTIVE COMPARATOR

Single injection and optional touch up injection with Restylane Lyft Lidocaine

Device: Restylane Lyft Lidocaine

Interventions

GP0112 DEVICE

Injectable gel

GP0112

Restylane Lyft Lidocaine DEVICE

Injectable gel

Restylane Lyft Lidocaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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;

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (8)

Galderma Research Site

Cologne, 50996, Germany

Location

Galderma Research Site

Darmstadt, 64283, Germany

Location

Galderma Research Site

Düsseldorf, 40212, Germany

Location

Galderma Research Site

Düsseldorf, 40545, Germany

Location

Galderma Research Site

Hamburg, 20146, Germany

Location

Galderma Research Site

Hamburg, 22609, Germany

Location

Galderma Research Site

Munich, 80469, Germany

Location

Galderma Research Site

Wuppertal, 42287, Germany

Location

Study Officials

• Study Director

  Galderma R&D

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2021
• First Posted: October 28, 2021
• Study Start: February 22, 2022
• Primary Completion: February 19, 2023
• Study Completion: November 18, 2023
• Last Updated: August 25, 2022

Record last verified: 2022-02

Locations

DE (8)