Safety and Performance of DKL Crosslinked Sodium Hyaluronate 26 Dermal Filler for Cheek Augmentation

NCT05021926 | Completed

• 1 other identifier: VAL-P69
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pivotal, prospective, active-controlled, randomized, double blinded (blinded evaluator and subject), intra-individual split-face comparison, non-inferiority study of DKL crosslinked sodium hyaluronate 26 versus Juvederm Voluma™ after treatment of subcutaneous to upper-periostea tissue, or deep dermis implantation for cheek augmentation and age-related facial-volume deficit.

Conditions

Aging Problems

Keywords

Age related facial-volume deficit

Outcome Measures

Primary Outcomes (1)

• Comparison of the rate of responders determined by the aesthetic improvement of the midface according to live on-site evaluator-rated MMVS at 6 months post-treatment between the investigational device and comparator product.

  The MMVS is a 4 point scale ranging from 1 (fairly full) to 4 (substantial loss, clearly apparent hollowing). Response is defined as ≥ 1-point improvement on the MMVS for each side of the midface compared to baseline. Each side of the midface is to be assessed separately.

  Baseline (pre-treatment) to 6 months post-treatment

Secondary Outcomes (8)

• Comparison of the rate of responders determined by the aesthetic improvement of the midface according to live on-site evaluator-rated MMVS at 1, 3 and 9 months post-treatment between the investigational device and comparator product.

  Baseline (pre-treatment) to 1, 3 and 9 months post-treatment

• Comparison of the mean change in evaluator-rated MMVS from baseline (pre-treatment) to at 1, 3, 6 and 9 months post-treatment between the investigational device and comparator product.

  Baseline (pre-treatment) to 1, 3, 6 and 9 months post-treatment

• Subject-rated aesthetic improvement in appearance according to GAIS at 1, 3, 6 and 9 months post-treatment. Each side of the midface is to be assessed separately.

  Baseline (pre-treatment) to 1, 3, 6 and 9 months post-treatment

• Evaluating Investigator-rated aesthetic improvement in appearance according to the GAIS at 1, 3, 6 and 9 months post-treatment. Each side of the midface is to be assessed separately.

  Baseline (pre-treatment) to 1, 3, 6 and 9 months post-treatment

• Usability of the device

  Baseline - treatment

Study Arms (2)

Investigational device

EXPERIMENTAL

DKL crosslinked sodium hyaluronate 26

Device: DKL crosslinked sodium hyaluronate 26

Comparator product

EXPERIMENTAL

Juvéderm Voluma™ with lidocaine (Allergan, Inc)

Device: Juvéderm Voluma™ with lidocaine (Allergan, Inc)

Interventions

DKL crosslinked sodium hyaluronate 26 DEVICE

is injected into the midface on Day 1. The volume of injection will not exceed 2 mL per side. If applicable, a touch-up of DKL crosslinked sodium hyaluronate 26 will be injected on Day 30; the volume of injection will not exceed 1 mL per side.

Investigational device

Juvéderm Voluma™ with lidocaine (Allergan, Inc) DEVICE

is injected into the midface on Day 1. The volume of injection will not exceed 2 mL per side. If applicable, a touch-up of Juvéderm Voluma™ will be injected on Day 30; the volume of injection will not exceed 1 mL per side.

Comparator product

Eligibility Criteria

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

You may qualify if:

• Review and sign the Independent Ethics Committee (IEC)-approved Informed Consent Form (ICF) prior to any study-related procedures being performed. In addition, the subject will be asked to provide a separate release for use of their photographs in publications and the clinical investigation report (CIR). The subject has a right to refuse the photo release without jeopardizing their eligibility to participate in the study.
• Male and female subject aged 18 to 65 years (inclusive) at the time of screening.
• The subject desires cheek augmentation and/or correction of age-related midface contour deficiencies.
• Midface with a MMVS score of 3 (moderate loss of fullness with slight hollowing below malar prominence) or 4 (substantial loss of fullness in the midface area, clearly apparent hollowing below malar prominence) on each side of the face as assessed by the blinded evaluator. Both sides of the face should have the same scoring.
• Female of child-bearing potential (sexually active and not sterile nor postmenopausal for at least 1 year) should have a urine pregnancy test evaluated as negative on the day of enrolment, and agree to use a reliable method of contraception for the duration of the study (effective birth control measures include sexual abstinence, combined \[estrogen and progestogen containing\] hormonal contraception associated with inhibition of ovulation \[oral, intravaginal, transdermal\], progestogen-only hormonal contraception associated with inhibition of ovulation \[oral, injectable, implantable\], intrauterine device \[IUD\] or intrauterine hormone-releasing system \[IUS\] and/or condom with spermicide).
• Subject agrees to abstain from any facial cosmetic or surgical procedures during the study period.
• Subject agrees to refrain from excessive weight gain or loss (±10%) during the investigation period.
• Subject has adequate understanding of the local language to understand verbal and written subject information and is willing to comply with the study requirements.

You may not qualify if:

• History of any clinically significant disease or disorder, including porphyria or systemic disorders affecting wound healing, which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
• Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational device and comparator.
• History of anaphylaxis, multiple severe allergies, atopy, or allergy to sodium hyaluronate products or to streptococcal proteins or have plans to undergo desensitization therapy during the term of the study.
• History of immune system disorders (e.g., autoimmune disease, human immunodeficiency virus \[HIV\]-positive status, history of immune system degradation, or recurrent herpes simplex).
• History of streptococcal disease (e.g. recurrent sore throat) and subjects with rheumatic fever, as judged by the investigator.
• Dermatological problems (e.g. cutaneous lesions, inflammatory skin conditions, hypertrophic scars or a tendency for keloid formation) at the discretion of the investigator.
• Noticeable scarring (including acne scarring), prior surgery, an active inflammation, infection, cancerous or pre-cancerous lesion, history of prior significant trauma to the midface, such as dog bite or laceration, resulting in formation of a scar, or unhealed wound or have undergone radiation treatment in the area to be treated.
• Cheek tattoos, piercings, facial hair, or scars that would interfere with visualization of the cheek area for the effectiveness assessments.
• Very thin skin in the mid-facial region, tendency to accumulate fluid in the lower eyelids, or large infraorbital fat pads, i.e., significant convexity or projection from the infraorbital fat pads.
• Mid-face volume deficit due to congenital defect, trauma, abnormalities in adipose tissue related to immune-mediated diseases such as generalized lipodystrophy (e.g., juvenile dermatomyositis), partial lipodystrophy (e.g., Barraquer-Simons syndrome), inherited disease or HIV-related disease.
• Moderate or severe abnormal midface or cheek asymmetry.
• Ongoing or history of use of immunosuppressive therapy.
• Use of anti-coagulation, anti-platelet, or thrombolytic medications, anti-inflammatory drugs, or other substances known to increase coagulation time (as detailed in Section 9.6.2) within 10 days prior to treatment with the investigational device and comparator.
• Use of any new (i.e. that the subject has not used before) facial over-the-counter or prescription, oral or topical, anti-wrinkle products within 90 days prior to enrolment or planning to begin use of such products at any time during the study.
• NOTE: Continued therapy with some cosmeceuticals (e.g., alpha hydroxyl acids, glycolic acids, retinol, or retinoic acids) is allowed if the regimen was established ≥ 90 days prior to enrolment. The use of sunscreens is also allowed.

Sponsors & Collaborators

• Dr. Korman Laboratories Ltd.: lead
• CTC Clinical Trial Consultants AB: collaborator

Study Sites (1)

CTC Clinical Trial Consultants AB

Uppsala, 752 37, Sweden

Location

Study Officials

• Johan Nilsson, MD, PhD

  CTC Clinical Trial Consultants AB

  PRINCIPAL INVESTIGATOR

• Mohammad Alimohammadi, MD, PhD

  Almo Alo AB

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: This is a double blinded (blinded evaluator and subject) study and the allocation of treatments will not be disclosed until clean file has been declared and the database has been locked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Pivotal, prospective, active-controlled, randomized, double blinded (blinded evaluator and subject), intra-individual split-face comparison, non-inferiority study

Study Record Dates

• First Submitted: August 19, 2021
• First Posted: August 26, 2021
• Study Start: August 30, 2021
• Primary Completion: January 6, 2023
• Study Completion: January 6, 2023
• Last Updated: July 5, 2023

Record last verified: 2023-07

Locations

SE (1)