Explorative, double-blind, randomized, controlled multi-center phase II study to evaluate the efficacy and safety of topically applied combinational product LAS41003 once daily versus corresponding mono-preparations in the treatment of superficial infected eczema - LA 41003

• Conditions: Patients aged 18 and older suffering from at least one clinically diagnosed superinfected or impetiginised eczema such as e.g.•superinfected or impetiginised atopic eczema•superinfected or impetiginised allergic contact eczema•superinfected or impetiginised toxic contact eczema•(nummular) microbial eczema•superinfected or impetiginised eczema of unknown origin.; MedDRA version: 12.0Level: LLTClassification code 10021773Term: Infected eczema; MedDRA version: 12.0Level: LLTClassification code 10014184Term: Eczema; MedDRA version: 12.0Level: LLTClassification code 10014188Term: Eczema allergic; MedDRA version: 12.0Level: LLTClassification code 10014191Term: Eczema atopic; MedDRA version: 12.0Level: LLTClassification code 10014199Term: Eczema infected; MedDRA version: 12.0Level: LLTClassification code 10014201Term: Eczema nummular; MedDRA version: 12.0Level: LLTClassification code 10051890Term: Eczema impetiginous; MedDRA version: 12.0Level: LLTClassification code 10000618Term: Actinic reticuloid-photosensitive eczema; MedDRA version: 12.0Level: LLTClassification code 10001712Term: Allergic eczema

• Registration Number: EUCTR2009-011931-11-DE
• Lead Sponsor: Almirall Hermal GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08-03
• Last Update Posted: 17 December 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

1.Signed and dated written informed consent
2.Caucasian male and female patients
3.Aged = 18 years
4.Have at least one clinically diagnosed superficial infected eczema confirmed by the following symptoms:
•exudation/crusting
•oozing
•erythema
•edema
The cumulative score for these symptoms is at least grade 6 (according to a 4-point severity score used for grading each of the symptoms; Intensities: None = 0, Mild = 1, Moderate = 2, Severe = 3).
5.The minimal area of the target eczema (selected for complete efficacy evaluation) is not less than 2 cm2
6.Physical ability to apply the study preparations correctly and to follow the study restrictions and visits
7.Women of childbearing potential are allowed to participate in this study, only if they use a highly effective method of contraception.

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

1.Known hypersensitivity, intolerance or allergies against Octenidine, Prednicarbate or other ingredients of the investigational medicinal products (e.g. cetearyl alcohol etc.)
2.Patients who have general signs of systemic infections like fever, malaise, lymphagitis or swollen lymph nodes and/or need systemic antibiotic treatment
3.Patients who have a bacterial skin infection which, due to depth and severity, could not be appropriately treated with a topical antimicrobial or antiseptic medication
4.Have evidence of clinically significant or unstable medical conditions such as:
•metastatic tumor or tumor with high probability of metastatic spread
•immunosuppressive disorder (e.g. HIV)
•hematologic, hepatic, renal, neurologic or endocrine disorder
•insulin-dependent diabetes mellitus and/or hypoglycaemia if unstable or clinically manifested even under treatment
5.Diagnose of the following disease:
•Known active tuberculosis or any history of past tuberculosis of skin
•Suspected or proven parasitic infection of the treatment
treatment site (e.g. scabies)
•Psoriasis
•Suspected or proven viral infection of skin (e.g. Herpes)
6.Localization of the eczema:
•palms of the hands
•sole of a foot
•face
7.An area of more than 8 palms (corresponding to a body surface area of about 1200 cm2) is covered with superficial infected eczema
8.Have received the following topical treatments for any indication in the treatment areas within the designated time period before treatment with investigational medicinal product (IMP):

Treatment Time Period
Topical antibiotics 6 weeks
Topical antimycotics 2 weeks
Topical steroids 2 weeks
Topical immunomodulators 2 weeks
Antiseptic agents 1 week

9.Have received the following systemic treatments within the designated period before treatment with IMP:

Treatment Time Period
Interferon 6 months
Cytotoxic drugs 6 months
Immunomodulators or
immuno-suppressive therapies 3 months
Drugs known to have
major organ toxicity 4 weeks

Antibiotics 4 weeks
Antimycotics
Corticosteroids (oral or injectable) 4 weeks
Inhaled corticosteroids 4 weeks
(>1200 microg/day for beclomethasone, or >600 microg/day for fluticasone)
Antihistamines 48 hours

10.Have received any topical treatment with antibiotics, antimycotics, immunomodulators and corticosteroid preparations within the last 2 weeks before treatment with IMP
11.Any topical treatment with antiseptics agents within one week before treatment with IMP
12.Patients having any significant physical abnormalities (e.g. tattoos) in the potential treatment area that may cause difficulty with examination or final evaluation
13.Patients not willing to stop using skin care products (including sunscreens and make-ups) and washing products during the study within the treatment areas
14.Have any dermatological disease in the treatment areas or surrounding area that may be exacerbated by treatment with topical Pre

Study & Design

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