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.

Part of paid clinical trials in Monroeville, Pennsylvania.

Sponsor
SerenaGroup, Inc.
Study ID
NCT07473674
Status
Completed

Conditions

  • Healthy Adult

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

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.

Study Details

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.

Key Dates

Start date
Apr 19, 2026
Status verified
May 2026
Primary completion
Apr 19, 2026
Completion
Apr 22, 2026

Study Design

Enrollment
5 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • 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.

Primary Outcome Measure

Skin Prick Test Wheal Diameter [ Time Frame: 15 minutes, ~6 hours (±30 minutes), and 24-48 hours after SPT administration ]

Locations (1)

FacilityCityStateZIPSite coordinators
SerenaGroup MonroevilleMonroevillePennsylvania15146-

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SerenaGroup Monroeville· Monroeville, PA

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