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

NCT06810856 | Completed

• 1 other identifier: REPRIP2M
• Study Type: interventional
• Target: 215
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

HRIPT; Skin Irritation; Contact Sensitization; Patch Testing; Dermatological Safety

Outcome Measures

Primary Outcomes (1)

• 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.

  Days 1 to 22 (Induction Phase)

Secondary Outcomes (1)

• Incidence of Sensitization Reactions During Challenge Phase

  Days 36 to 40 (Challenge Phase)

Study Arms (1)

Medical-Grade Norway Spruce Resin product (Abilar) Topical Safety Study

EXPERIMENTAL

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

Interventions

Abilar® Resin Salve DEVICE

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

Medical-Grade Norway Spruce Resin product (Abilar) Topical Safety Study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteers, of either sex, aged at least 18 years.
• Completed written informed consent.

You may not qualify if:

• Pregnancy or lactation.
• Inadequate or non-existent contraception (women of child bearing potential only).
• A current skin disease of any type apart from mild facial acne (e.g. eczema, psoriasis).
• Heavy alcohol consumption (i.e. more than 21 units per week or 8 units a day for men, more than 14 units per week or 4 units a day for women).
• Current use or history of repeated use of street drugs.
• A febrile illness lasting more than 24 hours in the six days prior to first patch application.
• Significant past medical history of hepatic, renal, cardiac, pulmonary, digestive, haematological, neurological, locomotor or psychiatric disease.
• History of asthma only if requiring regular medication or hay fever that required prescription treatment in two or more of the previous three years.
• A history of multiple drug hypersensitivity.
• Concurrent medication likely to affect the response to the test articles or confuse the results of the study.
• Known sensitivity to the test articles or their constituents including patch materials.
• Current treatment by a physician for allergy unless physician consulted by Investigator and participation approved.
• Participation in a repeat insult patch test (RIPT) or follow-up work within the last month.
• Sensitisation or questionable sensitisation in a RIPT.
• Recent immunisation (less than 10 days prior to test patch application).

Sponsors & Collaborators

• Repolar Pharmaceuticals Oy: lead
• Princeton Consumer Research: collaborator

Study Sites (1)

Princeton Consumer Research

Manchester, United Kingdom

Location

Related Publications (1)

• Jordan WP Jr, King SE. Delayed hypersensitivity in females. The development of allergic contact dermatitis in females during the comparison of two predictive patch tests. Contact Dermatitis. 1977 Feb;3(1):19-26. doi: 10.1111/j.1600-0536.1977.tb03582.x.

  PMID: 844299 BACKGROUND

Related Links

• Related Info

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: This study was conducted as a single-blind HRIPT, where participants were not informed of the identity of the test article applied to their skin. However, as only one test product was used without a control or comparison group, ClinicalTrials.gov does not allow classification as "Single-Blind," and the study is categorized as "Open Label" in this registration.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a single-group interventional study in which all participants received the same topical test product applied via occlusive patches. The study was designed to evaluate skin irritation and sensitization potential using a repeat insult patch test protocol.

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: February 6, 2025
• Study Start: October 16, 2019
• Primary Completion: October 25, 2019
• Study Completion: October 25, 2019
• Last Updated: February 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• 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.

Locations

GB (1)