Atopic dermatitis
Conditions
Interventions
Product Name: Diacerein
Product Code: 13739-02-1
Pharmaceutical Form: Cream
INN or Proposed INN: DIACEREIN
CAS Number: 13739-02-1
Concentration unit: g gram(s)
Concentration type: equal
Concentration
Sponsors
University Hospital of Dermatology, Paracelsus Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Minimum age of 18 years - Atopic dermatitis, mild to medium degree of severity (SCORAD =65 years) yes F.1.3.1 Number of subjects for this age range 1
Exclusion criteria
Exclusion criteria: - Simultaneous participation in another clinical study - Known or suspected intolerances against diacerein, auxiliaries of the investigational product (especially tartrazine) or substances with similar structure. - Known or suspected intolerances against the cream base. - Pregnancy or lactation - Use of topic, anti-pruritic therapy of antibiotic therapy at the treated body areas, 7 days before the beginning of the trial. - Systemic therapy with known sedative or anti-pruretic effect 2 weeks before the beginning of the trial. - Topical application of Tacrolimus cream 0,03% or pimecrolimus cream 1% two weeks before the beginning of the trial on the treated body areas. - Phototherapy or systemic therapy with known effect on atopic dermatitis one month before the beginning of the trial. - Clinically super infected atopic dermatitis at the treated skin area. - Further skin diseases, apart from atopic dermatitis, at the treated skin areas like for example tinea corporis, intertriginous tinea, scabies, impetigo or chickenpox. - Other relevant diseases (acute infections,active tumors, ...) - Patients with severe hepatic impairment - immunosuppresed patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Reduction of local pruritus by 4 points (according to analogue scale) within 4 weeks;Secondary Objective: a. Improvement of the skin by 30% according to the modified SCORAD (scoring atopical dermatitis) assessment tool b. Improvement of life quality (questionnaires). c. Determination of Il-1ß levels in patient serum.;Primary end point(s): Reduction of pruritus by 4 points according to analogue scale.;Timepoint(s) of evaluation of this end point: After 4 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Improvement of the skin by 30% according to local SCORAD - Improvement of life quality (according to questionnaire). - Monitoring of systemic Diacerein and IL-1ß levels.;Timepoint(s) of evaluation of this end point: After 4 weeks. | — |
Countries
Austria
Contacts
Public ContactScientific associate
University Hospital for Dermatology
Outcome results
None listed