NCT05021913

Safety and Performance of DKL Crosslinked Sodium Hyaluronate 23 Dermal Filler for Improvement of NLF Appearance

A Clinical Study to Evaluate the Safety and Performance of DKL Crosslinked Sodium Hyaluronate 23 Dermal Filler for Improvement of Nasolabial Fold Appearance

• 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 23 versus Juvederm Volift™ after injection into the mid to deep dermis for correction of moderate to deep nasolabial folds (NLFs).

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 23 versus Juvederm Volift™ after injection into the mid to deep dermis for correction of moderate to deep nasolabial folds (NLFs). 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 NLF will be treated with the investigational device and which NLF will be treated with the comparator device. The subjects will undergo baseline assessments of NLF Wrinkle Severity Rating Scale (WSRS) 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, NLF WSRS 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 NLF 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 during the first 14 days after the injection. Subjects receiving touch-up will attend and additional evaluation visit one month after touch-up (in addition to other visits). The treating investigators will complete a usability questionnaire.

Conditions

• Aging, Premature

Interventions

Type	Name	Description
DEVICE	DKL crosslinked sodium hyaluronate 23	is injected into the NLF on Day 1. The volume of injection will not exceed 2 mL per side. If applicable, a touch-up of DKL crosslinked sodium hyaluronate 23 will be injected on Day 30; the volume of injection will not exceed 1 mL per side.
DEVICE	Juvéderm Volift™ with lidocaine (Allergan, Inc)	is injected into the NLF on Day 1. The volume of injection will not exceed 2 mL per side. If applicable, a touch-up of Juvéderm Volift™ will be injected on Day 30; the volume of injection will not exceed 1 mL per side.

Timeline

• Start date: 2021-08-20
• 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