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
SerenaGroup, Inc.
20 participants
Feb 27, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria13
- 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 Criteria10
- 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
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Interventions
A collagen-based material applied under occlusive patch conditions to assess skin irritation and sensitization in healthy adult participants.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07473661