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. (SPT)

May 13, 2026 updated by: SerenaGroup, Inc.

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Monroeville, Pennsylvania, United States, 15146
        • SerenaGroup Monroeville

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Skin Prick Test Procedure
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
A collagen-based material applied during a standardized skin prick test procedure to assess local skin responses in healthy adult participants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
15 minutes, ~6 hours (±30 minutes), and 24-48 hours after SPT administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin Prick Test Wheal Diameter in Participants With Fitzpatrick Skin Type VI Following Application of SILURCLOUD™ Fibrous Collagen Matrix
Time Frame: 15 minutes, approximately 6 hours (±30 minutes), and 24-48 hours after skin prick test administration
Allergic skin response in participants with Fitzpatrick Skin Type VI will be assessed using a standardized skin prick test. The reaction will be quantified by measuring the mean diameter of the wheal at the test site in millimeters (mm). A wheal ≥3 mm is considered a positive response.
15 minutes, approximately 6 hours (±30 minutes), and 24-48 hours after skin prick test administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SerenaGroup, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 19, 2026

Primary Completion (Actual)

April 19, 2026

Study Completion (Actual)

April 22, 2026

Study Registration Dates

First Submitted

March 4, 2026

First Submitted That Met QC Criteria

March 10, 2026

First Posted (Actual)

March 16, 2026

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00093080

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The plan for sharing individual participant data (IPD) has not yet been determined. Any potential sharing of de-identified participant-level data will be evaluated by the sponsor after study completion and in accordance with applicable privacy regulations and sponsor policies.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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