Diacerein for the treatment of atopic dermatitis

• Conditions: Atopic dermatitis; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2014-005593-11-AT
• Lead Sponsor: niversity Hospital of Dermatology, Paracelsus Medical University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-13
• Last Update Posted: 14 March 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Minimum age of 18 years
- Atopic dermatitis, mild to medium degree of severity (SCORAD < 50 points), with according diagnostic criteria after Hanifin and Rajka
- Presence of lesional skin changes of mild to medium grade, characterized by the modified, local SCORAD (scoring atopic dermatitis) of at least 4 and confirmed by a qualified investigator.
- Presence of mild to medium degree lesions on at least 3% of the body surface, suitable for topical therapy
- signature patient 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 9
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified