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

Human Repeat Insult Patch Test (HRIPT): Assessment of Skin Irritation and Sensitization of a Collagen-Based Material in Healthy Volunteers

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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