Allergic Contact DermatitisNCT05858723
Repeated Open Application Test (ROAT) Study With Hydroperoxides of Linalool
A study testing ROAT in people with Allergic Contact Dermatitis, run by National Allergy Research Center, Denmark.
Trial summary
Linalool is currently one of the most used fragrance substances in cosmetic and household products. Previous studies report a high prevalence (5.9-11.7%) of contact allergy to hydroperoxides of linalool (Lin-OOH)1.0% in pet. among patch tested patients. Read more about this study
- Who is it for?
- Ages 18 to 110 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergic Contact Dermatitis
- What is being tested?
- ROAT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Aug 2023to Jul 2024
- 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 to 110 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Allergic participants:
- Inclusion criteria
- Positive (at least one reading) or doubtful patch test (at least two readings) result to hydroperoxides of Linalool within the last ten years
- Aged 18 years or older
- Received written and verbal information of the study
- Signed written consent form
- Exclusion criteria
- Active eczema in test areas (volar forearms)
- Pregnancy or breast feeding
- Treatment with topical corticosteroids or other immune suppressants on/near test areas within two weeks prior to study start
- Systemic immune-suppressant treatment within seven days prior to study start
- UV exposure of test areas within three weeks prior to study start
- Unable to cooperate or communicate with the investigators
Healthy controls:
- Inclusion criteria
- Aged 18 years or older
- Received written and verbal information of the study
- Signed written consent form
- Exclusion criteria
- Known or possible contact allergy to hydroperoxides of Linalool
- Known contact allergy to other fragrance allergens
- Active eczema or other known relevant skin diseases
- Pregnancy or breast feeding
- Treatment with topical corticosteroids or other immune suppressants on/near test areas within four weeks prior to study start.
- Systemic immune-suppressant treatment within four weeks prior to study start.
- UV exposure of test areas within three weeks prior to study start.
- Participation in other clinical studies within four weeks prior to study start.
- Unable to cooperate or communicate with the investigators.
About this study
Official title: Allergic Contact Dermatitis to Hydroperoxides of Linalool - a Repeated Open Application Test (ROAT) Study
Linalool is currently one of the most used fragrance substances in cosmetic and household products. Previous studies report a high prevalence (5.9-11.7%) of contact allergy to hydroperoxides of linalool (Lin-OOH)1.0% in pet. among patch tested patients. The optimal test concentration of Lin-OOH in patch tests is not known and requires further investigation. It is of great importance to establish the optimal test concentration and elicitation threshold of Lin-OOH to improve diagnosis and prevent development of Allergic Contact Dermatitis (ACD).
We want to mimic real-life exposure to Lin-OOH, by conducting a ROAT (Repeated Open Application Test) study, on 40 adult participants (20 patients with confirmed contact allergy to Lin-OOH, and 20 healthy participants) to low doses of Lin-OOH using a simulated "perfume", during a maximum of 21 days of exposure.
Read more
With this knowledge, we aim to:
- Establish the optimal patch test concentration to diagnose ACD to Lin-OOH
- In case of confirmed contact allergy, examine the threshold value for the development of ACD upon daily exposure to a simulated leave-on cosmetic product
- Conditions
- Allergic Contact Dermatitis
- Being tested
- ROAT
- Medical subject headings
- Dermatitis, Allergic Contact
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ROATDiagnostic test
Also called Patch testing and punch biopsies
Repeated Open Application Test
| Study group | Role | What they receive |
|---|---|---|
| Allergic participants | Experimental | Not described Receives: Diagnostic Test: ROAT |
| Healthy participants | Experimental | Not described Receives: Diagnostic Test: ROAT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish the optimal patch test concentration to diagnose allergic contact dermatitis to hydroperoxides of linalool via a Repeated Open Application Test
Establish the optimal patch test concentration to diagnose allergic contact dermatitis to hydroperoxides of linalool via Repeated Open Application Test
Measured: 6 months
In case of confirmed contact allergy, examine the threshold value for the development of ACD upon daily exposure to a simulated leave-on cosmetic product
In case of confirmed contact allergy, examine the threshold value for the development of ACD upon daily exposure to a simulated leave-on cosmetic product
Measured: 6 months
Secondary outcomes (1)
The Lin-OOH chemicals can penetrate the skin barrier and reside in the local skin tissue
Chemical analysis of skin punch biopsies from the exposed skin of the patients' lower back: time of flight secondary ion mass spectrometry (ToF-SIMS) analysis of Lin-OOH in the skin.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2023
- Study startAug 2023 (estimated)
- Primary completionJan 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic Contact DermatitisStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Allergy Research Center, Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sofia Hedvig Christina Botvid, National Allergy Research Center, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05858723
- Sponsor's protocol ID
- H-23018400
- Status last verified
- May 2023
- First submitted
- 2 May 2023
- Last updated
- 15 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allergic Contact Dermatitis to Hydroperoxides of Linalool - a Repeated Open Application Test (ROAT) Study
- ClinicalTrials.gov ID
- NCT05858723
- Acronym / sponsor ID
- H-23018400
- Conditions
- Allergic Contact Dermatitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Allergy Research Center, DenmarkUniversity, hospital or other
- Study start
- Aug 2023 (estimated)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 15 May 2023 (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.
Linalool is currently one of the most used fragrance substances in cosmetic and household products. Previous studies report a high prevalence (5.9-11.7%) of contact allergy to hydroperoxides of linalool (Lin-OOH)1.0% in pet. among patch tested patients. The optimal test concentration of Lin-OOH in patch tests is not known and requires further investigation. It is of great importance to establish the optimal test concentration and elicitation threshold of Lin-OOH to improve diagnosis and prevent development of Allergic Contact Dermatitis (ACD).
We want to mimic real-life exposure to Lin-OOH, by conducting a ROAT (Repeated Open Application Test) study, on 40 adult participants (20 patients with confirmed contact allergy to Lin-OOH, and 20 healthy participants) to low doses of Lin-OOH using a simulated "perfume", during a maximum of 21 days of exposure.
With this knowledge, we aim to:
- Establish the optimal patch test concentration to diagnose ACD to Lin-OOH
- In case of confirmed contact allergy, examine the threshold value for the development of ACD upon daily exposure to a simulated leave-on cosmetic product
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Allergic participants | Experimental | Diagnostic Test: ROAT |
| Healthy participants | Experimental | Diagnostic Test: ROAT |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| ROATAlso: Patch testing and punch biopsiesRepeated Open Application Test | Diagnostic test | Allergic participants, Healthy participants |
Primary outcome
Establish the optimal patch test concentration to diagnose allergic contact dermatitis to hydroperoxides of linalool via a Repeated Open Application Test
Time frame: 6 months
Establish the optimal patch test concentration to diagnose allergic contact dermatitis to hydroperoxides of linalool via Repeated Open Application Test
In case of confirmed contact allergy, examine the threshold value for the development of ACD upon daily exposure to a simulated leave-on cosmetic product
Time frame: 6 months
In case of confirmed contact allergy, examine the threshold value for the development of ACD upon daily exposure to a simulated leave-on cosmetic product
1 secondary outcome
The Lin-OOH chemicals can penetrate the skin barrier and reside in the local skin tissue
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2023.
- Individual participant dataSharing planned: No
Related trials for Allergic Contact Dermatitis
Not yet recruiting
Use of Silk Fibroin Dressings in Primary Total Hip Arthroplasty
Allergic Contact Dermatitis (ACD)
Not yet recruitingPhase 4
Reliability of Expired Allergens in Patch Testing: A Comparative Study With Non-Expired Series
Allergic Contact Dermatitis
Active, not recruitingPhase 4
The Effects of Dupilumab on Allergic Contact Dermatitis
Allergic Contact Dermatitis
Active, not recruitingPhase 2/3
Using a Contact Dermatitis Model With Biologic Medications to Study Skin Inflammation
Skin Inflammation, Allergic Contact Dermatitis
Not yet recruiting
Evaluation of Hypersensitivity Reactions to Silk Fibroin Versus 2-octyl Cyanoacrylate Mesh in Shoulder Surgery
Hypersensitivity Reactions, Allergic Contact Dermatitis
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.
Questions about this trial
What is this clinical trial studying?
A study testing ROAT in people with Allergic Contact Dermatitis, run by National Allergy Research Center, Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 15 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Establish the optimal patch test concentration to diagnose allergic contact dermatitis to hydroperoxides of linalool via a Repeated Open Application Test (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 May 2023.