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

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07473674

Acronym

SPT

Enrollment

Registered

2026-03-16

Start date

2026-04-19

Completion date

2026-04-22

Last updated

2026-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Adult

Keywords

Skin Prick Test, SPT, Collagen Matrix

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.

Interventions

DEVICECollagen 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
Skin Prick Test Wheal Diameter	15 minutes, ~6 hours (±30 minutes), and 24-48 hours after SPT administration	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).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 16, 2026