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HRIPT for Collagen Dressing

NCT06283173 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2025-03-12

Study results available
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Summary

The objectives of this study are to determine by repetitive epidermal contact, the primary or cumulative irritation and the allergic contact sensitization potential of the ColActive Plus Collagen Matrix Dressing, under maximized conditions, with controlled product quantity and application site.

Conditions

  • Skin Sensitisation

Interventions

DEVICE

ColActive Plus Collagen Matrix Dressing

Induction phase: Test article applied with Hill Top chamber every 48+ hours over 3 weeks. Rest phase: 10-day rest period with no application. Challenge phase: Test article applied for 48 hours and evaluated through 48 hours post removal. The positive control is evaluated at Induction 1 only. The negative control is applied following the same schedule as the test article.

Sponsors & Collaborators

  • ALS Beauty and Personal Care

    collaborator INDUSTRY

  • Covalon Technologies Inc.

    lead INDUSTRY

Principal Investigators

  • Jordan DeSantis, MHI, BS · ALS

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-31
Primary Completion
2024-03-22
Completion
2024-03-22
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06283173 on ClinicalTrials.gov