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

NCT06810856 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 215

Last updated 2025-02-06

No results posted yet for this study

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.

Conditions

  • Skin Irritation
  • Skin Sensitization

Interventions

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.

Sponsors & Collaborators

  • Princeton Consumer Research

    collaborator OTHER

  • Repolar Pharmaceuticals Oy

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-16
Primary Completion
2019-10-25
Completion
2019-10-25

Countries

  • United Kingdom

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 NCT06810856 on ClinicalTrials.gov