Ignite Creation Date:
2024-05-06 @ 6:58 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05858723
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-05-15
First Post:
2023-05-02
Brief Title:
Repeated Open Application Test ROAT Study With Hydroperoxides of Linalool
Sponsor:
National Allergy Research Center Denmark
Organization:
National Allergy Research Center Denmark
Study Overview
Official Title:
Allergic Contact Dermatitis to Hydroperoxides of Linalool - a Repeated Open Application Test ROAT Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-05
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:
None
Brief Summary:
Linalool is currently one of the most used fragrance substances in cosmetic and household products Previous studies report a high prevalence 59-117 of contact allergy to hydroperoxides of linalool Lin-OOH10 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 Establish the optimal patch test concentration to diagnose ACD to Lin-OOH
2 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
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 Establish the optimal patch test concentration to diagnose ACD to Lin-OOH
2 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None