Bovine Atelocollagen Skin Sensitization Test

  • STATUS
    Recruiting
  • participants needed
    550
  • sponsor
    AscentX Medical, Inc.
Updated on 27 September 2022
Accepts healthy volunteers

Summary

Bovine atelocollagen skin testing of healthy adult volunteers to investigate the potential of allergy to atelocollagen medical device implants

Description

Day 01: Receive 0.1 mL intradermal injection of atelocollagen skin test into left volar forearm.

Day 15: Receive 2nd intradermal injection of 0.1 mL atelocollagen skin test into right volar forearm (14 days after 1st injection).

Day 45: Final assessment of both injection sites (30 days after 2nd injection)

Note: ALL injection sites will be assessed clinically at 30 minutes (for observational purposes) and at 72 hours (to determine response) after each injection. Visit windows for 72 hour assessments, and Day 15 and Day 45 visits can occur up to 96 hours (4 days) after target time.

Details
Condition Healthy
Treatment Bovine atelocollagen intradermal injection
Clinical Study IdentifierNCT05235087
SponsorAscentX Medical, Inc.
Last Modified on27 September 2022

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