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.

NCT07473674 | Completed FDA Device

• 1 other identifier: Pro00093080
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Skin Prick Test; SPT; Collagen Matrix

Outcome Measures

Primary Outcomes (1)

• Skin Prick Test Wheal Diameter

  Allergic skin response will be assessed using a standardized skin prick test procedure. The reaction will be quantified by measuring the mean wheal diameter at the test site in millimeters (mm).

  15 minutes, ~6 hours (±30 minutes), and 24-48 hours after SPT administration

Study Arms (1)

Skin Prick Test Procedure

EXPERIMENTAL

Participants will undergo a standardized skin prick test using a collagen-based material to evaluate local skin responses in healthy adult volunteers.

Device: Collagen Matrix Skin Prick Test Device

Interventions

Collagen Matrix Skin Prick Test Device DEVICE

A collagen-based material applied during a standardized skin prick test procedure to assess local skin responses in healthy adult participants.

Skin Prick Test Procedure

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adult volunteers
• Age 18 to 70 years
• Able to comply with study procedures

You may not qualify if:

• Use of medications that may interfere with skin test responses
• Known allergy to personal care products or adhesives
• History of autoimmune disease
• History of cancer
• Uncontrolled chronic medical conditions
• History of dermatographism
• Known allergy to study materials
• Known hypersensitivity to study materials
• Active dermatitis or eczema at the test site

Sponsors & Collaborators

• SerenaGroup, Inc.: lead

Study Sites (1)

SerenaGroup Monroeville

Monroeville, Pennsylvania, 15146, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 16, 2026
• Study Start: April 19, 2026
• Primary Completion: April 19, 2026
• Study Completion: April 22, 2026
• Last Updated: May 15, 2026

Record last verified: 2026-05

Locations

US (1)