Multicentric, randomized, double-blinded, vehicle-controlled, phase III-bilateral comparative study for treatment of staphylococcus superinfection in atopic dermatitis with hydrophobic Triclosan-cream 2% (InfectoDermaSept) - TADTRIC

• Conditions: Staphylococcus super infection in atopic dermatitis; MedDRA version: 9.1Level: LLTClassification code 10042566Term: Superinfection

• Registration Number: EUCTR2006-004233-15-DE
• Lead Sponsor: InfectoPharm Arzneimittel und Consilium GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-16
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

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

Inclusion Criteria

Signed ICF (informed consent form),
patients aged 6 month to 50 years,
first atopic dermatitis diagnosis at least 4 Week prior study entry,
actual clinically manifested atopic dermatitis,
disseminated symmetric eczemas of the limbs,
SCORAD (SCORing Atopic Dermatitis) (ESCORAD) between 5 and 12,
Staphylococcus superinfection.
Are the trial subjects under 18? yes
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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Treatment with or need of oral or topical corticosteroids, non steroidal immunosuppressant agents, pimecrolimus, tacrolimus, antibiotics, immunomodulators, antihistamines;
usage of soaps, lotions, creams and solutions with antiseptic ingredients e.g. potassium permanganate, chlorhexidine, povidone iodine;
treatment with phototherapy or ultraviolet (UV) treatment or photochemotherapy (PUVA);
peracute or erosive eczema;
exsudative phases of atopic dermatitis;
known hypersensitivity to triclosan or one of the ingredients of the cream;
immunodeficiency;
distinct impetigo, erysipelas or abscess;
systemic bacterial or mycotic infections and severe viral systemic infections;
severe systemic diseases;
pregnancy and lactation;
previous participation in a study within the last 30 days;
alcohol and drug abuses.

Study & Design

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