NCT04846530

Teosyal RHA® Histology and Intradermal Implantation Evaluation Study

A Prospective, Single Blind, Single-center Study Evaluating the Histology and Intradermal Implantation of the Teosyal RHA® Collection of Fillers

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 8 (actual)
• Sponsor: Revance Therapeutics, Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Accepted

Summary

The Teosyal RHA® family of products (RHA® 1, RHA® 2, RHA® 3, and RHA® 4) is approved in Canada for the correction of facial wrinkles and folds. In this study, the approved products will be placed in small boluses (0.2 mL) intradermally to allow for punch biopsies of the post-auricular space to be taken. The biopsies will include the injected material and surrounding skin tissue. Biopsies will be taken immediately after implantation of the product and at Day 30 and assessed by an independent blinded pathologist.

Conditions

• Histology

Interventions

Type	Name	Description
DEVICE	RHA® 1, RHA® 2, RHA® 3, and RHA® 4	For each subject, two spaced boluses (0.2 mL each) of the product will be implanted on the same side (left or right side) in the post auricular area of the subject per treatment assignment. The assignment will specify one of the RHA® products to the left ear and another product to the right ear. Each subject will have a total of four boluses.

Timeline

• Start date: 2021-08-20
• Primary completion: 2021-10-07
• Completion: 2021-12-13
• First posted: 2021-04-15
• Last updated: 2021-12-01

Locations

1 site across 1 country: Canada