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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03313232

Enrollment

Registered

2017-10-18

Start date

2017-10-10

Completion date

2018-04-09

Last updated

2018-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Contact Dermatitis Due to Cosmetics

Brief 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

Interventions

OTHERROAT 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

OTHERROAT 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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Positive ROAT (minimum score of 5)	Day (D) 21	Proportion (%) of participants with a positive ROAT

Secondary

Measure	Time frame	Description
Minimal eliciting concentration (MEC)	Day (D) 7	Threshold concentration for a positive patch test

Other

Measure	Time frame	Description
Epidermal inflammatory markers	Positive ROAT or Day (D) 21	Levels of inflammatory markers (e.g. IL-1beta) from tape stripping of ROAT test areas

Countries

Denmark, Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026