Allergic Contact Dermatitis Clinical Trial
Official title:
Allergic Contact Dermatitis to Hydroperoxides of Linalool - a Repeated Open Application Test (ROAT) Study
Verified date | May 2023 |
Source | National Allergy Research Center, Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | July 2024 |
Est. primary completion date | January 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 110 Years |
Eligibility | Allergic participants: 1. 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 2. 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: 1. Inclusion criteria - Aged 18 years or older - Received written and verbal information of the study - Signed written consent form 2. 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
National Allergy Research Center, Denmark |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | 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. | 12 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03945760 -
Efficacy of Baricitinib In Treatment of Delayed-Type Hypersensitivity Versus Irritant Skin Reactions in Healthy Adult Male Subjects
|
Early Phase 1 | |
Not yet recruiting |
NCT05498467 -
The Role of Interleukin-1 Beta Targeted Therapy for Patients Suffering From Allergic Contact Dermatitis
|
Phase 3 | |
Active, not recruiting |
NCT03680131 -
Evaluation of EB01 Cream for the Treatment of Chronic Allergic Contact Dermatitis
|
Phase 2 | |
Recruiting |
NCT05535738 -
Using a Contact Dermatitis Model With Biologic Medications to Study Skin Inflammation
|
Phase 2/Phase 3 | |
Recruiting |
NCT06191627 -
Patient Experience and Quality of Patch Testing on the Legs vs Back
|
N/A | |
Completed |
NCT00867607 -
Safety, Tolerability, and Efficacy of 21 Days Dermal Application of MRX-6 on Mild to Moderate Contact Dermatitis
|
Phase 1/Phase 2 | |
Recruiting |
NCT00445029 -
Pathophysiological Study of Allergic Contact Dermatitis to Para-Phenylenediamine (PPD). Analysis of Cellular and Molecular Targets in Skin Inflammation
|
N/A | |
Completed |
NCT04365140 -
MicroRNA-126 and Its Target VCAM-1Dermatitis to Nickel
|
||
Recruiting |
NCT05991674 -
A Prospective Study to Investigate Contact Sensitization Using Classic and Machine Learning Techniques
|
||
Completed |
NCT00931242 -
Study of Apremilast in Atopic or Contact Dermatitis
|
Phase 2 | |
Completed |
NCT01798589 -
Bioequivalence of Ethylenediamine Dihydrochloride Study
|
Phase 4 | |
Completed |
NCT01546298 -
Immune Reactions in Contact Dermatitis Affected Skin
|
||
Completed |
NCT05339750 -
Allergy Skin Patch Artificial Intelligence (AI)
|
N/A | |
Recruiting |
NCT03935971 -
The Effects of Dupilumab on Allergic Contact Dermatitis
|
Phase 4 | |
Completed |
NCT01797562 -
Clinical Evaluation of T.R.U.E. Test Allergens in Children an Adolescents
|
N/A | |
Completed |
NCT02534441 -
Epidemiology and Co-Reactivity of Novel Surfactant Allergens
|
N/A | |
Not yet recruiting |
NCT01413477 -
Nickel Desensitization Using Topical Therapy
|
N/A | |
Completed |
NCT00133341 -
Clinical Evaluation of the 3 Allergens: Methyldibromoglutharonitrile, Parthenolide and Goldnatriumthiosulphate
|
Phase 2 | |
Completed |
NCT00132600 -
Clinical Evaluation of Bacitracin
|
Phase 2 | |
Completed |
NCT03902392 -
Red Grape Polyphenol Oral Administration to Women Affected by Nickel-mediated Allergic Contact Dermatitis
|
N/A |