An interventional study of Abilar® Resin Salve in Skin Irritation and Skin Sensitization, sponsored by Repolar Pharmaceuticals Oy. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-06.
Sponsored by Repolar Pharmaceuticals Oy · Not applicable, Interventional, and Other
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.
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.
Repolar Pharmaceuticals Oy is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Prohibitions and Restrictions:
Participants received repeated applications of a Medical-Grade Norway Spruce Resin product (Abilar) topical formulation using Finn chambers on Scanpor® tape. Patches were applied to the upper back for 47 hours per application over a three-week induction phase, followed by a challenge phase to assess potential delayed hypersensitivity reactions. Skin reactions were assessed at scheduled intervals by a blinded dermatologist using a standardized scoring system.
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.
Also known as: Abilar, Abilar® 10% Resin Salve, Norway Spruce Resin-Based Topical Medical Device, Picea abies Resin Salve, Abilar Wound Salve
Incidence of Skin Irritation During Induction Phase
The primary outcome measure was the percentage of participants exhibiting skin irritation reactions (e.g., erythema, edema, papules) at any time during the Induction Phase of the HRIPT study. Reactions were graded using a standardized visual scoring system.
Time frame: Days 1 to 22 (Induction Phase)
Incidence of Sensitization Reactions During Challenge Phase
This study assessed the presence of delayed hypersensitivity reactions following re-exposure to the test product after a rest period. Participants were evaluated one hour and 49 hours post-challenge patch removal using a standardized dermatological scoring system.
Time frame: Days 36 to 40 (Challenge Phase)
Plan to share: Yes — Individual participant data (IPD) collected throughout the study, including anonymized participant-level skin reaction assessments, will be made available upon request for research purposes.
Supporting information: Study protocol, Clinical study report
Time frame: Data will be available upon request after study completion and final publication, with an access period of 5 years post-publication.
Access criteria: Researchers requesting access to anonymized IPD must submit a written request outlining the intended research objectives. Data access will be granted following review and approval by the sponsor (Repolar Pharmaceuticals Oy) and compliance with data protection regulations.
Ran from Oct 2019 to primary completion in Oct 2019, 0 months.
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This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Repolar Pharmaceuticals Oy