Clinical trial NCT05622851: Comparative Ultrasound Analysis of Two Hyaluronic Acid Dermal Fillers
Official title: A Randomized, Split-face Clinical Study on Comparative Ultrasound Analysis of Two Hyaluronic Acid Fillers for Midface Correction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Volume Deficiency of the Midface
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2022-11-21
Enrollment: 11
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, split-face, subject-blinded, comparative
Primary purpose: TREATMENT

Brief summary: To assess and compare tissue aggregation and visualization of two Hyaluronic Acid fillers via ultrasound

Detailed description: This is a randomized, split-face, subject-blinded, comparative study to assess and compare tissue aggregation and visualization of two Hyaluronic Acid fillers via ultrasound.

This study is designed to enroll and randomize approximately 15 subjects in a 1:1 ratio of treatment to Restylane Contour or Juvederm Voluma. All subjects are to have midface volume loss and contour deficiency.

Eligible subjects are randomized to receive treatment were injected by the Treating Investigator at Baseline. The method of injection is at the discretion of the Treating Investigator. A sufficient amount of product is injected to achieve optimal correction of the midface, in the opinion of the Treating Investigator and subject.

At the 4-week visit, after all study procedures for the visit are completed, treated subjects have the option of receiving a touch-up treatment to achieve optimal aesthetic improvement. At the 6-month, 9-month, and 12-month visits, similar study procedures are performed.

Eligibility criteria: Inclusion Criteria:

* Subject with midface volume loss and contour deficiency
* Ability of giving consent for participation in the study
* Agreement to adhere to the procedures and requirements of the study and to report to the institute on the day(s) and at the time(s) scheduled for the assessments

Exclusion Criteria:

* History of allergy or hypersensitivity to lidocaine and/or injectable hyaluronic acid
* Previous permanent or semi-permanent implant in proposed treatment area
* Previous biodegradable tissue augmentation therapy in the proposed treatment area within 12 months prior to the baseline visit
* History of other facial treatment/procedure at the study area (midface) in the previous 6 months that would potentially interfere with study injections (e.g., facial surgery, oral surgery, resurfacing, mesotherapy, lipolytic injections, botulinum toxin injections)

Primary outcomes:
measure: Assess and compare tissue aggregation and visualization of Hyaluronic Acid fillers using ultrasound
timeFrame: Immediately post-treatment, 4 weeks, 6 months, 9 months, and 12 months after baseline
Secondary outcomes:
measure: Evaluate subject satisfaction using self-assessment questionnaire
timeFrame: 4 weeks, 6 months, 9 months, and 12 months after baseline
measure: Evaluate volume change in the treated areas using 3D imaging
timeFrame: 4 weeks, 6 months, 9 months, and 12 months after baseline
Other outcomes:
Locations:
city: Santa Rosa Beach
country: United States
facility: The Aesthetic Clinique
state: Florida
Study officials:
affiliation: The Aesthetic Clinique
name: Steven F Weiner, MD
role: PRINCIPAL_INVESTIGATOR
References: