NCT06283173

HRIPT for Collagen Dressing

Human Repeat Insult Patch Test (HRIPT): Assessment of Primary and Cumulative Skin Irritation and Skin Sensitization of a Product, Under Controlled and Maximized Conditions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: Covalon Technologies Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Detailed description

Approximately 75 healthy subjects satisfying all criteria listed below will be enrolled to complete the study with a minimum of 50 subjects. The test product will be applied on the 25-millimeter Hill Top Chamber®, which will be applied directly to the test site. The positive control will be applied to each subject for the first 48 hours only, and the negative control will be applied throughout the study along with the test product. Enough product will be used to cover the chamber. The procedure involves occlusive patching of the test product and control(s) for a minimum of 48 hours followed by an assessment. The procedure will be repeated until a series of 9 consecutive 48-hour exposures have been made over 3 consecutive weeks. This induction phase is followed by an approximate two-week rest period. The challenge phase consists of a challenge or test dose applied once to a previously unexposed test site. Clinical staff will remove the patches 48 hours post-application. Reactions will be scored 30 minutes post-removal, 24-hours post-removal, and 48-hours post-removal. Skin response at each application site will be evaluated according to the Berger and Bowman Scale.

Conditions

• Skin Sensitisation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-01-31
• Primary completion: 2024-03-22
• Completion: 2024-03-22
• First posted: 2024-02-28
• Last updated: 2025-03-12
• Results posted: 2025-03-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study