With the 24 allergens currently included in the TRUE test, about 60 -70% of contact allergic reactions are detected. Thus, there is a need for expanding the number of allergens included in TRUE Test® in order to detect more contact allergic reactions. Increasing the number of TRUE Test® allergens with up to 12 new allergens
Conditions
Interventions
Product Name: TRUE Test Steroids
Pharmaceutical Form: Cutaneous stick
INN or Proposed INN: Budesonide
CAS Number: 51333-22-3
Concentration unit: mg/m2 milligram(s)/square meter
Concentration type: equ
Sponsors
Mekos Laboratories AS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Suspected allergic contact dermatitis 2. Age > 18 years 3. Written informed consent 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: 1. Systemic- or topical treatment with corticosteroids during the last 2 weeks on the test area or near the test area or. 2. Treatment with/exposure to UV-light during the last 3 weeks. 3. Systemic immune suppressive treatment during the last 7 days. 4. Widespread active dermatitis 5. Dermatitis on the test area 6. Pregnancy, breastfeeding or insufficient contraception. 7. Participation in other clinical trials during the study period and 3 weeks prior to inclusion 8. Patients not able to co-operate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of the three allergens and compare the reactions to the present method, i.e. allergens in petrolatum.;Secondary Objective: To evaluate safety of the three allergens in question.;Primary end point(s): Assessment of efficacy after evaluation of the skinreactions day 3/4 and day 7 | — |
Countries
Sweden
Outcome results
None listed