Skin IrritationHRIPT-REPRIP2MNCT06810856
HRIPT Study to Evaluate the Irritation and Allergenic Potential of Medical-grade Norway Spruce (Picea Abies) Resin Salve (Abilar)
A study testing Abilar® Resin Salve in people with Skin Irritation and Skin Sensitization, run by Repolar Pharmaceuticals Oy at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Irritation, Skin Sensitization
- What is being tested?
- Abilar® Resin Salve
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 215 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Oct 2019to 25 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers, of either sex, aged at least 18 years.
- Completed written informed consent.
Who cannot join
- 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.
Show all 20Show fewer
- 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).
- A medical history indicating atopy.
- Prohibitions and Restrictions:
- No use of aspirin or non-steroidal anti-inflammatory drugs for the duration of the study.
- No use of sun beds or sun lamps and no deliberate exposure of the test sites to natural sunlight for the duration of the study.
- No immunisation from ten days prior to first patching until study completion.
Trial locations and contacts
1 site in 1 country.
About this study
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
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?
Read more
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.
Read the 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
- Being tested
- Abilar® Resin Salve
- Keywords
- HRIPT, Skin Irritation, Contact Sensitization, Patch Testing, Dermatological Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abilar® Resin SalveDevice
Also called Abilar, Abilar® 10% Resin Salve, Norway Spruce Resin-Based Topical Medical Device, Picea abies 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Abilar® Resin Salve |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Days 1 to 22 (Induction Phase)
Secondary outcomes (1)
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.
Measured: Days 36 to 40 (Challenge Phase)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start16 Oct 2019
- Primary completion25 Oct 2019
- Study completion25 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Skin IrritationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- Repolar Pharmaceuticals Oy
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Princeton Consumer Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06810856
- Sponsor's protocol ID
- REPRIP2M
- Acronym
- HRIPT-REPRIP2M
- Status last verified
- Feb 2025
- First submitted
- 24 Jan 2025
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 844299
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06810856
- Acronym / sponsor ID
- HRIPT-REPRIP2M / REPRIP2M
- Conditions
- Skin Irritation, Skin Sensitization
- Keywords
- HRIPT, Skin Irritation, Contact Sensitization, Patch Testing, Dermatological Safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- Repolar Pharmaceuticals OyIndustry (pharma, biotech, devices)
- Collaborators
- Princeton Consumer Research
- Study start
- 16 Oct 2019 (actual)
- Primary completion
- 25 Oct 2019 (actual)
- Study completion
- 25 Oct 2019 (actual)
- First posted
- 6 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Medical-Grade Norway Spruce Resin product (Abilar) Topical Safety Study | Experimental | Device: Abilar® Resin SalveParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy volunteers, of either sex, aged at least 18 years.
- Completed written informed consent.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abilar® Resin SalveAlso: Abilar, Abilar® 10% Resin Salve, Norway Spruce Resin-Based Topical Medical Device, Picea abies Resin SalveAbilar® 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. | Device | Medical-Grade Norway Spruce Resin product (Abilar) Topical Safety Study |
Primary outcome
Incidence of Skin Irritation During Induction Phase
Time frame: Days 1 to 22 (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.
1 secondary outcome
Incidence of Sensitization Reactions During Challenge Phase
Time frame: Days 36 to 40 (Challenge Phase)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Background: PubMed 844299Jordan 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abilar® Resin Salve in people with Skin Irritation and Skin Sensitization, run by Repolar Pharmaceuticals Oy at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Skin Irritation During Induction Phase (time frame: Days 1 to 22 (Induction Phase)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06810856, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.