An interventional study of ROAT in Allergic Contact Dermatitis, sponsored by National Allergy Research Center, Denmark. Not yet recruiting. Open to participants aged 18 Years to 110 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-15.
Sponsored by National Allergy Research Center, Denmark · Not applicable, Interventional, and Prevention
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:
1,435 studies on the registry are indexed under Dermatitis; 131 are open to participants now.
This study's planned enrollment of 40 is below the median of 64 across 1,131 interventional studies indexed under Dermatitis.
Browse Dermatitis studies →National Allergy Research Center, Denmark is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
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Allergic participants:
Inclusion criteria
Exclusion criteria
Healthy controls:
Inclusion criteria
Exclusion criteria
Diagnostic Test: ROAT
Diagnostic Test: ROAT
Repeated Open Application Test
Also known as: Patch testing and punch biopsies
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
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
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
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.
Time frame: 12 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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National Allergy Research Center, Denmark