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

NCT ID: NCT05858723

Last Updated: 2023-05-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-31
• Study Completion Date: 2024-07-31

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:

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

Conditions

Allergic Contact Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Allergic participants

Group Type: EXPERIMENTAL

ROAT

Intervention Type: DIAGNOSTIC_TEST

Repeated Open Application Test

Healthy participants

Group Type: EXPERIMENTAL

ROAT

Intervention Type: DIAGNOSTIC_TEST

Repeated Open Application Test

Interventions

ROAT

Repeated Open Application Test

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Patch testing and punch biopsies

Eligibility Criteria

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

• 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:

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 110 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Allergy Research Center, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Sofia Hedvig Christina Botvid

M.D, Ph.D. fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

H-23018400

Identifier Type: -

Identifier Source: org_study_id