Dose range finding pilot study for diagnostic patch testing with ME-PPD

Dose range finding pilot study for diagnostic patch testing with ME-PPD - ME-PPD: 0.1%, 0.25%, 0,5%, 1% and 2%.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON43828

Enrollment

Registered

2015-10-29

Start date

2015-11-16

Completion date

Unknown

Last updated

2024-08-26

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

Conditions

allergic contact dermatitis contact eczema

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - A history of (mild, moderate of severe) allergic contact dermatitis after exposure to a PPD-containing product (mostly hair dye); - A positive patch-test to PPD (1% in white petrolatum); - Adulthood (>=18 years); - Legal competence.

Exclusion criteria

Exclusion criteria: - Skin anomalies at the volar side of the forearms or back; - Active skin disease at the volar side of the forearms or back; - Immunosuppressive medication (e.g. oral cortosteroïds, methotrexate, cyclosporine) during or in the previous 4 weeks of the study; - Pregnancy or pregnancywish; - Breastfeeding.

Design outcomes

Primary

Measure	Time frame
The primary study parameters are the results of the epicutaneous patch tests for the different concentrations of ME-PPD and the results of the open use test, graded according to guidelines of the International Contact Dermatitis Research Group (ICDRG): - , +?, + , ++ , +++ or IR (irritation response).	—

Secondary

Measure	Time frame
The secondary study parameters are the results of the epicutaneous patch tests to the MAPPD and DAPPD graded according to the ICDRG : - , +?, + , ++, +++ or IR (irration response).	—

Countries

Netherlands

Outcome results