Human Repeat Insult Patch Test to Evaluate Skin Irritation and Sensitization in Healthy Volunteers (NCT07473661) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Human Repeat Insult Patch Test to Evaluate Skin Irritation and Sensitization in Healthy Volunteers
United States20 participantsStarted 2026-02-27
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.,…
What they're measuring
1
Dermal Irritation Score Using the International Contact Dermatitis Research Group (ICDRG) Scale
Timeframe: During the induction phase (approximately 3 consecutive weeks)