At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Human Repeat Insult Patch Test (HRIPT): Assessment of Primary and Cumulative Skin Irritation and Skin Sensitization of a Product, Under Controlled and Maximized Conditions
In Brief
A clinical study evaluating ColActive Plus Collagen Matrix Dressing for Skin Sensitisation. Completed, enrolled 86 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.