Human Repeat Insult Patch Test to Evaluate Skin Irritation and Sensitization in Healthy Volunteers
NCT07473661 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13
Last updated 2026-05-15
Summary
This study evaluates skin irritation and sensitization following repeated application of a collagen-based material in healthy adult volunteers under controlled conditions. Skin responses will be assessed during study participation.
Conditions
- Healthy Adult
Interventions
- DEVICE
-
Collagen-Based Material
A collagen-based material applied under occlusive patch conditions to assess skin irritation and sensitization in healthy adult participants.
Sponsors & Collaborators
-
SerenaGroup, Inc.
lead NETWORK
Study Design
- Allocation
- NA
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-02-27
- Primary Completion
- 2026-05-08
- Completion
- 2026-05-08
- FDA Device
- Yes
Countries
- United States
Study Locations
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