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.

SerenaGroup, Inc.8 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy Adult

Interventions

Collagen Matrix Skin Prick Test DeviceDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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).

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