CompletedNot Applicable

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.

United States5 participantsStarted 2026-04-19

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Skin Prick Test Wheal Diameter

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

Trial details

NCT IDNCT07473674

SponsorSerenaGroup, Inc.

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2026-04-19

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