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.

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.

Completed

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Key information

Conditions

Healthy Adult

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SerenaGroup Monroeville

Monroeville, Pennsylvania, 15146, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

Skin Prick Test Wheal Diameter

Time frame: 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).

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Completed

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Sponsors and collaborators

Lead sponsor

SerenaGroup, Inc.

Network

Registry information

Official study title

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

Acronym: SPT

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Mar 16, 2026
Registry last updated: May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed