Allergic Contact Dermatitis Due to CosmeticsNCT03313232
Low Dose Exposure to Oxidized R-limonene - A Repeated Open Application Test (ROAT) Study
A study testing ROAT with oxidized R-limonene at 1%, 0.3% and 0.1% and ROAT with oxidized R-limonene at 1% in people with Allergic Contact Dermatitis Due to Cosmetics, run by Herlev and Gentofte Hospital at 2 sites in 2 countries.
Trial summary
This study evaluates the clinical and molecular effect of daily exposure to low doses of the fragrance contact allergen oxidized R-limonene. Three groups of participants are included: 1) Patients with a previous positive patch test to oxidized R-Limonene, 2) patients with a previous doubtful patch test to oxidized… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Allergic Contact Dermatitis Due to Cosmetics
- What is being tested?
- ROAT with oxidized R-limonene at 1%, 0.3% and 0.1% and ROAT with oxidized R-limonene at 1%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 10 Oct 2017to 9 Apr 2018
- 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
- Positive patch test (at least one reading) or doubtful patch test (at least two readings) to oxidized R-limonene 3% pet. (with 0.33% hydroperoxides content) according to international guidelines, within the last five years.
- Aged 18 years or older
- Received written and verbal information on the study.
- Signed written consent form.
Who cannot join
- Active eczema in test areas.
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Denmark1 site
Department of Dermatology and Allergy, Gentofte University Hospital
Hellerup, DK, 2900
Sweden1 site
Department of Occupational and Environmental Dermatology, Sahlgrenska University Hospital
Gothenburg, SE, 41345
About this study
Official title: Low Dose Exposure to Oxidized R-limonene - A Double Blinded Vehicle Controlled Repeated Open Application Test (ROAT) Study
This study evaluates the clinical and molecular effect of daily exposure to low doses of the fragrance contact allergen oxidized R-limonene. Three groups of participants are included: 1) Patients with a previous positive patch test to oxidized R-Limonene, 2) patients with a previous doubtful patch test to oxidized R-limonene and 3) healthy controls with no contact allergy to oxidized R-limonene
- Being tested
- ROAT with oxidized R-limonene at 1%, 0.3% and 0.1%, ROAT with oxidized R-limonene at 1%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ROAT with oxidized R-limonene at 1%, 0.3% and 0.1%Other
A twice daily repeated open application test (ROAT) study for up to three weeks of exposure to oxidized R-limonene at 1%, 0.3% and 0.1% concentrations
ROAT with oxidized R-limonene at 1%Other
A twice daily repeated open application test (ROAT) study for up to three weeks of exposure to oxidized R-limonene at a 1% concentration
| Study group | Role | What they receive |
|---|---|---|
| Fragrance allergic patients | Experimental | Patients with a previous positive patch test to oxidized R-Limonene. Patients will have an initial patch test dilution series with oxidized R-limonene performed on the back followed by twice daily exposure to oxidized R-limonene at three different concentrations and a vehicle control on the forearms for up to three weeks. Receives: Other: ROAT with oxidized R-limonene at 1%, 0.3% and 0.1% |
| Possible fragrance allergic patients | Experimental | Patients with a previous doubtful patch test to oxidized R-limonene. Patients will have an initial patch test dilution series with oxidized R-limonene performed on the back followed by twice daily exposure to oxidized R-limonene at three different concentrations and a vehicle control on the forearms for up to three weeks. Receives: Other: ROAT with oxidized R-limonene at 1%, 0.3% and 0.1% |
| Healty controls | Experimental | Healthy controls with no contact allergy to oxidized R-limonene. Healthy controls will have en initial diagnostic patch test with oxidized R-limonene performed followed by twice daily exposure to oxidized R-limonene at one concentration and a vehicle control on the forearms for up to three weeks. Receives: Other: ROAT with oxidized R-limonene at 1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive ROAT (minimum score of 5)
Proportion (%) of participants with a positive ROAT
Measured: Day (D) 21
Secondary outcomes (1)
Minimal eliciting concentration (MEC)
Threshold concentration for a positive patch test
Measured: Day (D) 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2017
- Study start10 Oct 2017
- Primary completion9 Apr 2018
- Study completion9 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic Contact Dermatitis Due to CosmeticsStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev and Gentofte Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, Sahlgrenska University Hospital, Göteborg University
- Responsible party
- Principal investigator, Niels Højsager Bennike, Herlev and Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03313232
- Sponsor's protocol ID
- HGH-2017-017
- Status last verified
- Apr 2018
- First submitted
- 3 Oct 2017
- Last updated
- 10 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Dose Exposure to Oxidized R-limonene - A Double Blinded Vehicle Controlled Repeated Open Application Test (ROAT) Study
- ClinicalTrials.gov ID
- NCT03313232
- Acronym / sponsor ID
- HGH-2017-017
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Herlev and Gentofte HospitalUniversity, hospital or other
- Collaborators
- University of Copenhagen, Sahlgrenska University Hospital, Göteborg University
- Study start
- 10 Oct 2017 (actual)
- Primary completion
- 9 Apr 2018 (actual)
- Study completion
- 9 Apr 2018 (actual)
- First posted
- 18 Oct 2017 (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.
This study evaluates the clinical and molecular effect of daily exposure to low doses of the fragrance contact allergen oxidized R-limonene. Three groups of participants are included: 1) Patients with a previous positive patch test to oxidized R-Limonene, 2) patients with a previous doubtful patch test to oxidized R-limonene and 3) healthy controls with no contact allergy to oxidized R-limonene
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fragrance allergic patients | Experimental | Other: ROAT with oxidized R-limonene at 1%, 0.3% and 0.1%Patients with a previous positive patch test to oxidized R-Limonene. Patients will have an initial patch test dilution series with oxidized R-limonene performed on the back followed by twice daily exposure to oxidized R-limonene at three different concentrations and a vehicle control on the forearms for up to three weeks. |
| Possible fragrance allergic patients | Experimental | Other: ROAT with oxidized R-limonene at 1%, 0.3% and 0.1%Patients with a previous doubtful patch test to oxidized R-limonene. Patients will have an initial patch test dilution series with oxidized R-limonene performed on the back followed by twice daily exposure to oxidized R-limonene at three different concentrations and a vehicle control on the forearms for up to three weeks. |
| Healty controls | Experimental | Other: ROAT with oxidized R-limonene at 1%Healthy controls with no contact allergy to oxidized R-limonene. Healthy controls will have en initial diagnostic patch test with oxidized R-limonene performed followed by twice daily exposure to oxidized R-limonene at one concentration and a vehicle control on the forearms for up to three weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Positive patch test (at least one reading) or doubtful patch test (at least two readings) to oxidized R-limonene 3% pet. (with 0.33% hydroperoxides content) according to international guidelines, within the last five years.
- Aged 18 years or older
- Received written and verbal information on the study.
- Signed written consent form.
Key exclusion criteria (6 listed)
- Active eczema in test areas.
- 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.
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 |
|---|---|---|
| ROAT with oxidized R-limonene at 1%, 0.3% and 0.1%A twice daily repeated open application test (ROAT) study for up to three weeks of exposure to oxidized R-limonene at 1%, 0.3% and 0.1% concentrations | Other | Fragrance allergic patients, Possible fragrance allergic patients |
| ROAT with oxidized R-limonene at 1%A twice daily repeated open application test (ROAT) study for up to three weeks of exposure to oxidized R-limonene at a 1% concentration | Other | Healty controls |
Primary outcome
Positive ROAT (minimum score of 5)
Time frame: Day (D) 21
Proportion (%) of participants with a positive ROAT
1 secondary outcome
Minimal eliciting concentration (MEC)
Time frame: Day (D) 7
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 10 Apr 2018.
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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ROAT with oxidized R-limonene at 1%, 0.3% and 0.1% and ROAT with oxidized R-limonene at 1% in people with Allergic Contact Dermatitis Due to Cosmetics, run by Herlev and Gentofte Hospital at 2 sites in 2 countries.
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 4 inclusion and 6 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 10 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark, Sweden. 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?
Positive ROAT (minimum score of 5) (time frame: Day (D) 21). 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 10 Apr 2018.