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Repeated Open Application Test (ROAT) Study With Hydroperoxides of Linalool

Primary Purpose

Allergic Contact Dermatitis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ROAT
Sponsored by
National Allergy Research Center, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Allergic Contact Dermatitis

Eligibility Criteria

18 Years - 110 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Allergic participants

    Healthy participants

    Arm Description

    Outcomes

    Primary Outcome Measures

    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
    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

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    May 2, 2023
    Last Updated
    May 12, 2023
    Sponsor
    National Allergy Research Center, Denmark
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05858723
    Brief Title
    Repeated Open Application Test (ROAT) Study With Hydroperoxides of Linalool
    Official Title
    Allergic Contact Dermatitis to Hydroperoxides of Linalool - a Repeated Open Application Test (ROAT) Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 2023 (Anticipated)
    Primary Completion Date
    January 2024 (Anticipated)
    Study Completion Date
    July 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    National Allergy Research Center, Denmark

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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. 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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Allergic Contact Dermatitis

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Allergic participants
    Arm Type
    Experimental
    Arm Title
    Healthy participants
    Arm Type
    Experimental
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    ROAT
    Other Intervention Name(s)
    Patch testing and punch biopsies
    Intervention Description
    Repeated Open Application Test
    Primary Outcome Measure Information:
    Title
    Establish the optimal patch test concentration to diagnose allergic contact dermatitis to hydroperoxides of linalool via a Repeated Open Application Test
    Description
    Establish the optimal patch test concentration to diagnose allergic contact dermatitis to hydroperoxides of linalool via Repeated Open Application Test
    Time Frame
    6 months
    Title
    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
    Description
    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
    Secondary Outcome Measure Information:
    Title
    The Lin-OOH chemicals can penetrate the skin barrier and reside in the local skin tissue
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    110 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Repeated Open Application Test (ROAT) Study With Hydroperoxides of Linalool

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