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

NCT05858723 | Unknown DMC

• 1 other identifier: H-23018400
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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. 1.Establish the optimal patch test concentration to diagnose ACD to Lin-OOH
2. 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

Outcome Measures

Primary Outcomes (2)

• 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

  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

  6 months

Secondary Outcomes (1)

• The Lin-OOH chemicals can penetrate the skin barrier and reside in the local skin tissue

  12 months

Study Arms (2)

Allergic participants

EXPERIMENTAL

Diagnostic Test: ROAT

Healthy participants

EXPERIMENTAL

Diagnostic Test: ROAT

Interventions

ROAT DIAGNOSTIC_TEST

Repeated Open Application Test

Also known as: Patch testing and punch biopsies

Allergic participants; Healthy participants

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• Aged 18 years or older
• Received written and verbal information of the study
• Signed written consent form
• 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.

Sponsors & Collaborators

• National Allergy Research Center, Denmark: lead

MeSH Terms

Conditions

Dermatitis, Allergic Contact

Interventions

Patch Tests

Condition Hierarchy (Ancestors)

Dermatitis, Contact; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Skin Tests; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D, Ph.D. fellow

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: May 15, 2023
• Study Start: August 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: July 1, 2024
• Last Updated: May 15, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share