Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2025-12-25 @ 9:01 PM
Study NCT ID:
NCT06810856
Status:
COMPLETED
Last Update Posted:
2025-02-06
First Post:
2025-01-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
HRIPT Study to Evaluate the Irritation and Allergenic Potential of Medical-grade Norway Spruce (Picea Abies) Resin Salve (Abilar)
Sponsor:
Repolar Pharmaceuticals Oy
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HRIPT-REPRIP2M
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: