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

NCT07473661 | Completed FDA Device

• 1 other identifier: Pro00093062
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Adult

Keywords

skin irritation; skin sensitization; HRIPT; Fibrous Collagen Matrix

Outcome Measures

Primary Outcomes (1)

• Dermal Irritation Score Using the International Contact Dermatitis Research Group (ICDRG) Scale

  Dermal irritation response will be assessed using the International Contact Dermatitis Research Group (ICDRG) skin reaction grading scale (0-4).

  During the induction phase (approximately 3 consecutive weeks)

Secondary Outcomes (1)

• Allergic Contact Sensitization Response Using ICDRG Scale

  Through completion of all skin assessments during the study (approximately 5-6 weeks)

Study Arms (1)

Human Repeat Insult Patch Test Procedure

EXPERIMENTAL

Participants will undergo repeated occlusive patch applications of a collagen-based material to assess skin irritation and sensitization in healthy adult volunteers.

Device: Collagen-Based Material

Interventions

Collagen-Based Material DEVICE

A collagen-based material applied under occlusive patch conditions to assess skin irritation and sensitization in healthy adult participants.

Human Repeat Insult Patch Test Procedure

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• SerenaGroup, Inc.: lead

Study Sites (1)

SerenaGroup Monroeville

Monroeville, Pennsylvania, 15146, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 16, 2026
• Study Start: February 27, 2026
• Primary Completion: May 8, 2026
• Study Completion: May 8, 2026
• Last Updated: May 15, 2026

Record last verified: 2026-05

Locations

US (1)