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

NCT05021926 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2023-07-05

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • CTC Clinical Trial Consultants AB

    collaborator INDUSTRY

  • Dr. Korman Laboratories Ltd.

    lead INDUSTRY

Principal Investigators

  • Johan Nilsson, MD, PhD · CTC Clinical Trial Consultants AB

  • Mohammad Alimohammadi, MD, PhD · Almo Alo AB

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-30
Primary Completion
2023-01-06
Completion
2023-01-06

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05021926 on ClinicalTrials.gov