NCT05021926

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

A Clinical Study to Evaluate the Safety and Performance of DKL Crosslinked Sodium Hyaluronate 26 Dermal Filler for Cheek Augmentation.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Dr. Korman Laboratories Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

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 cheek augmentation and age-related facial-volume deficit. Approximately 40 subjects will be randomized and treated. Subjects will come to the research clinic for up to 6 visits, including a screening/baseline visit and up to 5 follow-up visits. At Screening eligible subjects (males and females aged 18 to 65 years) will be randomized as to which side of the midface will be treated with the investigational device and which side will be treated with the comparator device. The subjects will undergo baseline assessments of Medicis Midface Volume Scale (MMVS) by the evaluating investigator and have baseline two-dimensional (2D) photos taken, prior to treatment with the investigational device and comparator. Treatment will be performed by an unblinded treating investigator. Following treatment, the subjects will complete a subject eDiary in which they will assess pre-defined treatment related events experienced during the first 14 days after the injection. Additional visits will take place 1, 3, 6 and 9 months after the treatment. During these visits the subjects will undergo evaluations by an evaluating investigator blinded to the treatment allocation. Assessments will include photography, MMVS and Global Aesthetic Improvement Scale (GAIS). The subjects will also evaluate treatment outcome using the GAIS and complete a patient satisfaction questionnaire. The investigator will record any adverse events (AEs) that have occurred and will note their severity and relationship to the injected product. An optional touch-up treatment will be performed one month after the initial treatment at the discretion of the treating investigator. Subjects requiring touch-up will receive touch-up according to the original randomization scheme, i.e. the investigational device and comparator product will be injected to the same midface side according to the randomization scheme. Following touch-up, these subjects will be asked to complete a subject eDiary for assessment of pre-defined treatment related events experienced 14 days after the injection. Subjects receiving touch-up will attend an additional evaluation visit 1 month after touch-up (in addition to other visits). The treating investigators will complete a usability questionnaire.

Conditions

• Aging Problems

Interventions

Type	Name	Description
DEVICE	DKL crosslinked sodium hyaluronate 26	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.
DEVICE	Juvéderm Voluma™ with lidocaine (Allergan, Inc)	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.

Timeline

• Start date: 2021-08-30
• Primary completion: 2023-01-06
• Completion: 2023-01-06
• First posted: 2021-08-26
• Last updated: 2023-07-05

Locations

1 site across 1 country: Sweden