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Teosyal RHA® Histology and Intradermal Implantation Evaluation Study

NCT04846530 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 8

Last updated 2021-12-01

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Revance Therapeutics, Inc.

    lead INDUSTRY

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-20
Primary Completion
2021-10-07
Completion
2021-12-13

Countries

  • Canada

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 NCT04846530 on ClinicalTrials.gov