Human Repeat Insult Patch Test to Evaluate Skin Irritation and Sensitization in Healthy Volunteers

Completed · Not applicable

Conditions studied: Healthy Adult

In brief

This study evaluates skin irritation and sensitization following repeated application of a collagen-based material in healthy adult volunteers under controlled conditions. Skin responses will be assessed during study participation.

Key facts

Study ID

NCT07473661

Run by

SerenaGroup, Inc.

People needed

13

Starts

2026-02-27

Expected to finish

2026-05-08

Last updated by the study team

2026-05-15

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Adults aged 18 to 70 years
• Male and female participants
• Fitzpatrick Skin Types I and VI
• Participants of any race
• Participants of any ethnicity (Hispanic or Latino or Not Hispanic or Latino)
• Generally healthy, without dermatological or systemic conditions that could interfere with study participation or evaluation of results, as determined by the investigator
• Able to read and understand English and provide written informed consent
• Able to comply with study procedures and complete all required visits
• Willing to have test materials applied according to the study protocol
• Has not participated in a similar clinical study within the previous 30 days
• Agrees to avoid excessive sun exposure, sunbathing, or tanning during study participation
• Female participants of childbearing potential willing to undergo pregnancy testing prior to participation
• Agrees not to change current personal care products during study participation

You may not qualify if…

• Use of medications that may interfere with study results (e.g., corticosteroids, antihistamines, immunosuppressive agents, or high-dose NSAIDs)
• History of acute or chronic medical conditions that could interfere with study participation or increase risk (e.g., autoimmune disease, HIV infection)
• Chronic skin conditions such as atopic dermatitis or eczema
• Treatment for skin cancer within the previous 12 months
• Abnormal or damaged skin at test sites that could interfere with evaluation (e.g., sunburn, tattoos, scars, active dermatologic conditions)
• Diabetes requiring insulin therapy
• Pregnant, planning pregnancy, or breastfeeding
• Known hypersensitivity to personal care products, cosmetics, fragrances, or adhesives
• Known fish allergy
• Any condition that, in the opinion of the investigator, may compromise participant safety or study integrity

Where it is running

• SerenaGroup Monroeville — Monroeville, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.