contact allergy (allergic contact dermatitis)
Conditions
Interventions
Trade Name: Ecural 0,1% solution
Pharmaceutical Form: Cutaneous solution
Product Name: mometasone furoate 0.002%
Pharmaceutical Form: Cutaneous spray, solution
Pharmaceutical form of the placebo: Cut
Sponsors
GALENpharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Female or male subjects ? 18 years and ? 75 years of age in good general health • Individuals with a documented at least twofold positive (‘++’) patch reaction to one of the standard allergens in a patch test performed according to the guideline of the Deutsche Kontaktallergie Gruppe (DKG) version 05/2007 (http://www.uni-duesseldorf.de/awmf/ll/013-018.htm) in the last two years • Individuals who are willing and able to provide informed consent • Individuals who are willing and able to follow the requirements for study participation Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Pregnant or breast-feeding woman • Woman of child-bearing potential who plan to become pregnant or breast-feed • Subjects with known inflammatory and/or infectious skin diseases in particular individuals with skin conditions that, in the opinion of the investigator, are likely to increase the risk of unwanted side effects or complicate the assessments required according to the study protocol • Individuals with autoimmune and chronic inflammatory disorders including, but not limited to, lupus erythematosus, rheumatoid arthritis, HIV/AIDS, etc. • Individuals taking immunosuppressive drugs including, but not limited to, azathioprine, cyclosporine, tacrolimus, methotrexate, infliximab and other biologics • Individuals treated with corticosteroids systemically within 30 days prior to visit1 • Individuals treated with antihistamines systemically within the last 10 days prior to visit1 • Individuals receiving topical therapy in the test area within the last 14 days prior to visit1 • Individuals with extensive UV-irradiation within the last six weeks prior to visit1 • Individuals with known hypersensitivity to any ingredients contained in the products used for treatment of the patch test reactions according to the study protocol • Individuals who have participated in another clinical trial within the last 30 days prior to visit1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The efficacy of the treatment with mometasonfuroat cutaneous spray (solution) in four different concentrations (0.002%, 0.01%, 0.05%, 0.1%) in comparison with Ecural® 0.1% solution and a placebo assessed by the eczema score during seven-day treatment. In particular, the corresponding concentration of mometasonfuroat cutaneous spray showing equivalent or better efficacy than Ecural® 0.1% solution is to be determined.;Secondary Objective: The secondary objective is to evaluate the safety assessed by the clinician’s global assessment of local skin reaction and irritability (burning sensation, itching);Primary end point(s): Primary objective of this explorative study is to evaluate the efficacy of mometasonfuroat cutaneous spray (solution) in four different concentrations in comparison with a commercially-available mometasonfuroat solution (Ecural® 0.1%) and a placebo in subjects with contact allergies. Particularly, we want to determine the corresponding concentration of mometasonfuroat cutaneous spray that shows equivalent or better efficacy than Ecural® 0.1% solution. Efficacy is assessed by the local eczema score at V2, V5 and V8. Due to the small sample size and the exploratory character of the study, evaluations of the results are carried out on a descriptive level. The assessments of the local eczema scores are presented as means with intervals of confidence and standard deviations broken down by each treatment group and visit. | — |
Countries
Germany
Outcome results
None listed