Patients suffering from mild to moderate DAC with interest of body surface area not exceeding 20% MedDRA version: 9.1 Level: LLT Classification code 10056265 Term: Allergic contact dermatitis
Conditions
Interventions
Trade Name: OLUX*SCHIUMA CUT 100G 0,05%
Pharmaceutical Form: Cutaneous foam
INN or Proposed INN: Clobetasol
Concentration unit: % percent
Concentration type: equal
Concentration number: .05-
Trade Na
Sponsors
MIPHARM
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: both sexes aged between 18 and 70 years, suffering from allergic contact dermatitis mild to moderate with involvement of body surface area not exceeding 20%, providing written informed consent to participate in the study 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: allergic contact dermatitis to corticosteroids, allergic dermatitis from skin contact with interest exceeding 20%, pregnant or breastfeeding, use of corticosteroids topical or systemic in the last 4 weeks preceding the recruitment, use of immunosuppressive drugs in the last 6 months prior to recruitment , Use throughout the period of the study of cosmetic preparations can, in the opinion of the investigator, to some extent influence the assessment of the patient and / or interfere on clinical response preparations in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: assess the clinical efficacy of OLUX compared cream corticosteroid in topical treatment of allergic contact dermatitis;Secondary Objective: assess the compliance, safety and tolerability of OLUX compared to cream;Primary end point(s): Physician's Global Assessment (PGA) score; score of clinical evaluation of the signs and symptoms of injuries DAC | — |
Countries
Italy
Outcome results
None listed