NCT06810856

HRIPT Study to Evaluate the Irritation and Allergenic Potential of Medical-grade Norway Spruce (Picea Abies) Resin Salve (Abilar)

A Modified Draize Repeat Insult Patch Test in Healthy Volunteers, of Either Sex, to Investigate the Irritation and Allergenic Potential of One Test Article Following Repeated Cutaneous Patch Applications

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 215 (actual)
• Sponsor: Repolar Pharmaceuticals Oy · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to assess whether a medical-grade Norway spruce resin-based topical product (Abilar) causes skin irritation or allergic sensitization in healthy adult volunteers. The main questions it aims to answer are: Does the product cause skin irritation after repeated applications? Does the product induce sensitization (allergic contact dermatitis) after repeated exposure? Participants will: Have the test product applied to their skin via occlusive patches multiple times over three weeks. Undergo dermatological assessments for signs of erythema (redness), swelling, or sensitization at scheduled time points. Have a final challenge application on a new skin site after a rest period to check for delayed allergic reactions. This study follows Good Clinical Practice (GCP) guidelines and the Declaration of Helsinki. It was conducted at Princeton Consumer Research (PCR Corp, UK) with approval from the East Anglia Ethics Committee, UK.

Detailed description

Study Objective: This is a single-center, interventional study designed to evaluate the irritation and sensitization potential of a medical-grade Norway spruce resin-based wound care product (Abilar) using a Modified Draize Human Repeat Insult Patch Test (HRIPT). The study followed Good Clinical Practice (ICH GCP 1996) and the Declaration of Helsinki. Study Design: A total of 215 healthy adult volunteers were enrolled, with 207 completing the study. The study was conducted at Princeton Consumer Research (PCR Corp, UK) and was approved by the East Anglia Ethics Committee, UK. Participants received occlusive patches containing the test product, applied repeatedly over a three-week induction phase. After a rest period, a challenge application was placed on a new skin site to evaluate potential delayed-type hypersensitivity reactions. Single-center, interventional study with single-group assignment (no control group). Conducted under dermatological supervision at Princeton Consumer Research (PCR Corp, UK). Ethical approval was granted by the East Anglia Ethics Committee, UK. Study Period: October 16, 2019 - October 25, 2019. Methodology: Induction Phase (Days 1-21): Repeated application of occlusive patches with the test product to the same skin site three times per week. Skin assessments were conducted at multiple time points. Rest Period: No patch application for approximately 14 days. Challenge Phase (Day 38): A final application was made to a naïve skin site to assess delayed hypersensitivity responses. Scoring System: Skin reactions were graded using dermatological visual scoring for erythema, edema, and other signs of irritation or sensitization.

Conditions

• Skin Irritation
• Skin Sensitization

Interventions

Type	Name	Description
DEVICE	Abilar® Resin Salve	Abilar® Resin Salve is a medical-grade Norway spruce (Picea abies) resin-based topical medical device, classified as a Class IIb medical device in the EU. It is designed for wound care and skin protection, forming a moist healing barrier while exhibiting antimicrobial properties. It contains 10% of medical-grade Picea abies resin.

Timeline

• Start date: 2019-10-16
• Primary completion: 2019-10-25
• Completion: 2019-10-25
• First posted: 2025-02-06
• Last updated: 2025-02-06

Locations

1 site across 1 country: United Kingdom