NCT07473674

This Study Evaluates Skin Response Following Application of a Collagen-based Material in Healthy Adult Volunteers Using a Standardized Skin Prick Test. Skin Responses Will be Assessed at Multiple Time Points Following Application, and the Study is Intended to Evaluate Dermal Safety.

Skin Prick Test to Evaluate Allergenic Potential of a Collagen-Based Material in Healthy Volunteers

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (estimated)
• Sponsor: SerenaGroup, Inc. · Network
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This study evaluates the allergic (immunogenic) response following application of a collagen-based material in healthy adult volunteers using a standardized skin prick test. Skin responses will be assessed at multiple time points following application.

Conditions

• Healthy Adult

Interventions

Type	Name	Description
DEVICE	Collagen Matrix Skin Prick Test Device	A collagen-based material applied during a standardized skin prick test procedure to assess local skin responses in healthy adult participants.

Timeline

• Start date: 2026-04-01
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2026-03-16
• Last updated: 2026-04-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study