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

May 13, 2026 updated by: SerenaGroup, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Monroeville, Pennsylvania, United States, 15146
        • SerenaGroup Monroeville

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Human Repeat Insult Patch Test Procedure
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
A collagen-based material applied under occlusive patch conditions to assess skin irritation and sensitization in healthy adult participants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dermal Irritation Score Using the International Contact Dermatitis Research Group (ICDRG) Scale
Time Frame: During the induction phase (approximately 3 consecutive weeks)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Allergic Contact Sensitization Response Using ICDRG Scale
Time Frame: Through completion of all skin assessments during the study (approximately 5-6 weeks)
Allergic contact sensitization response will be assessed using the International Contact Dermatitis Research Group (ICDRG) skin reaction grading scale (0-4) following challenge exposure
Through completion of all skin assessments during the study (approximately 5-6 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SerenaGroup, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 27, 2026

Primary Completion (Actual)

May 8, 2026

Study Completion (Actual)

May 8, 2026

Study Registration Dates

First Submitted

March 4, 2026

First Submitted That Met QC Criteria

March 10, 2026

First Posted (Actual)

March 16, 2026

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00093062

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The plan for sharing individual participant data (IPD) has not yet been determined. Any potential sharing of de-identified participant-level data will be evaluated by the sponsor after study completion and in accordance with applicable privacy regulations and sponsor policies.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy Adult

Clinical Trials on Collagen-Based Material

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Philippines

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe