Low Dose Exposure to Oxidized R-limonene - A Repeated Open Application Test (ROAT) Study

Allergic Contact Dermatitis Due to Cosmetics Clinical Trial

Official title:

Low Dose Exposure to Oxidized R-limonene - A Double Blinded Vehicle Controlled Repeated Open Application Test (ROAT) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03313232
• Other study ID #: HGH-2017-017
• Status: Completed
• Phase: N/A
• First received: October 3, 2017
• Last updated: April 9, 2018
• Start date: October 10, 2017
• Est. completion date: April 9, 2018

Study information

• Verified date: April 2018
• Source: Herlev and Gentofte Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the clinical and molecular effect of daily exposure to low doses of the fragrance contact allergen oxidized R-limonene. Three groups of participants are included: 1) Patients with a previous positive patch test to oxidized R-Limonene, 2) patients with a previous doubtful patch test to oxidized R-limonene and 3) healthy controls with no contact allergy to oxidized R-limonene

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: April 9, 2018
• Est. primary completion date: April 9, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Positive patch test (at least one reading) or doubtful patch test (at least two readings) to oxidized R-limonene 3% pet. (with 0.33% hydroperoxides content) according to international guidelines, within the last five years.

• Aged 18 years or older

• Received written and verbal information on the study.

• Signed written consent form.

Exclusion Criteria:

• Active eczema in test areas.

• 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.

Related Conditions & MeSH terms

• Allergic Contact Dermatitis Due to Cosmetics
• Dermatitis
• Dermatitis, Allergic Contact
• Dermatitis, Contact

Intervention

Other:
• ROAT with oxidized R-limonene at 1%, 0.3% and 0.1%
A twice daily repeated open application test (ROAT) study for up to three weeks of exposure to oxidized R-limonene at 1%, 0.3% and 0.1% concentrations
• ROAT with oxidized R-limonene at 1%
A twice daily repeated open application test (ROAT) study for up to three weeks of exposure to oxidized R-limonene at a 1% concentration

Locations

Country	Name	City	State
Denmark	Department of Dermatology and Allergy, Gentofte University Hospital	Hellerup	DK
Sweden	Department of Occupational and Environmental Dermatology, Sahlgrenska University Hospital	Göteborg	SE

Sponsors (4)

Lead Sponsor	Collaborator
Herlev and Gentofte Hospital	Göteborg University, Sahlgrenska University Hospital, Sweden, University of Copenhagen

Countries where clinical trial is conducted

Denmark,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Epidermal inflammatory markers	Levels of inflammatory markers (e.g. IL-1beta) from tape stripping of ROAT test areas	Positive ROAT or Day (D) 21
Primary	Positive ROAT (minimum score of 5)	Proportion (%) of participants with a positive ROAT	Day (D) 21
Secondary	Minimal eliciting concentration (MEC)	Threshold concentration for a positive patch test	Day (D) 7