NCT04362891

Four Hyaluronic Acid Fillers for Lip Augmentation

Safety, Longevity and Patient Satisfaction Comparison of Four Hyaluronic Acid Soft Tissue Fillers in Lip Augmentation: Study Protocol for a Randomized Controlled Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 143 (actual)
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

There is need for evidence-based and reproducible data comparing the safety, longevity and patient satisfaction propensity of the various HA soft tissue filler products. Among cosmetic HA soft tissue filler procedures, especially the lip augmentation has become common. Therefore, the aim of this study is to determine whether a statistically significant difference can be detected in the safety, longevity and/or patient satisfaction related to four HA soft tissue filler products widely used for cosmetic lip augmentation. Specifically, the aim of this study is to determine whether superiority of one or more product(s) over the others can be detected.

Detailed description

Rationale: Currently, hyaluronic acid (HA) soft tissue fillers are widely employed in cosmetic medical practice for facial contouring and rejuvenation. Among these procedures, especially the lip augmentation has become common. To this end various products have become commercially available, however to date no robust evidence is available to support the safety, longevity or patient satisfaction propensity superiority of one product over the others. Objective: To assess whether superiority in safety, longevity and patient satisfaction propensity can be shown of one of four most frequently used FDA-approved and/or CE marked HA fillers worldwide, used to augment the lip, over the others. Study design: Multi-center, randomized, controlled, four group, parallel, triple-blind clinical trial of 160 adult participants. Study population: Consecutive healthy individuals with no history of previous lip treatment and a self-reported wish for lip augmentation, who present at one of the private cosmetic medicine clinics in the Netherlands, will be recruited. Intervention (if applicable): After giving informed consent, participants will be randomized to receive a protocoled lip augmentation procedure by the injection of either 1 mL of brand A, B, C or D. Main study parameters/endpoints: The primary outcome measure will be the absolute lip volume augmentation as measured by the Lemperle Lip Index from baseline to 3-months follow-up. Secondary outcomes will include the incidence of serious adverse reactions and side effects related to the procedure, the absolute volume augmentation from baseline to 2-weeks follow-up and self-reported quality of life and satisfaction with aesthetic results from baseline to 2-weeks follow-up as measured by validated FACE-Q questionnaire scores.

Conditions

• Lip

Interventions

Type	Name	Description
PROCEDURE	Cosmetic lip augmentation	The primary study treatment site will be the vermilion (body of the lip); additional areas (vermilion borders, Cupid's bow, philtral columns, and/or oral commissures) will be treated if deemed appropriate by the treating physician. Treatment will be administered through intradermal, subdermal, and/or intramuscular injection within the orbicularis oris muscle. Injection techniques for each area will include linear threading, serial puncture, fanning, and/or cross-hatching. The treating physician will determine the appropriate volume to inject based on clinical experience and the subject's goals for lip augmentation.

Timeline

• Start date: 2021-07-05
• Primary completion: 2022-01-12
• Completion: 2022-01-12
• First posted: 2020-04-27
• Last updated: 2022-03-22

Locations

4 sites across 1 country: Netherlands