Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

General inclusion criteria:

Signed and dated informed consent has been obtained
Age 18 - 70 years
Male or female
Female subjects of childbearing potential must be confirmed not pregnant by a negative urine pregnancy test prior trial treatment
Female subjects of childbearing potential must be willing to use effective contraceptive at trial entry until completion
Male subjects must agree to use adequate contraception for the duration of the trial

Additional inclusion criteria for Phase II of the study:

Localized disease (e.g. flexural eczema in a more or less symmetrical distribution on arms) where two individual lesions each covering an area between 10-200 cm2 and where each individual lesion has an investigators global assessment score between 1-3.
Additional localized lesion of area between 10-200 cm2 and where the individual lesion has an investigators global assessment score between 1-3.
Total localized disease not exceeding 20 % body surface area
Colonization of lesions with S.aureus as determined by cultivation

General exclusion criteria

Clinically relevant abnormalities in the laboratory testing, vital signs, ECG ( Phase I only) or physical examination
Presence of any skin condition (scars, tattoos,…) that would interfere with the placement of study medication
History of irritation to topical products
Current acute or chronic disease unless considered clinically irrelevant by the Investigator
Relevant history of malignancy, of renal, hepatic, cardiovascular, respiratory, gastrointestinal, musculoskeletal, skin (particularly at the site of drug application), haematological, endocrine or neurological diseases that may interfere with the aim of the study
Positive HIV serology or evidence of active hepatitis
Ascertained or presumptive hypersensitivity to the active principle and/or formulations ingredients of the study drugs (test, reference)
History of drug or alcohol abuse (>2 drinks/day, defined according to USDA Dietary Guidelines 2005)
caffeine (>5 cups coffee/tea/day) or tobacco abuse (consumption of 5 or more cigarettes/week)
abnormal or special diet (e.g. vegetarian diet)
Blood donations during 6 weeks prior to this study or planned within 6 weeks after the last blood withdrawal
Subject considered unable or unlikely (per Investigator judgment) to comply with safety and PK profiling requirements (follow-up visits)
Subjects who are pregnant (as determined by a positive pregnancy test at the screening visit) or lactating
Participation in another clinical trial with an investigational day within 4 weeks before screening

Additional exclusion criteria for Phase I of the study:

Regular use of medications
Use of any dermatological drug therapy on the arms within 14 days before day 1 of this study

Additional exclusion criteria for Phase II of the study:

Treatment with antibiotics (systemic or topical) within the past 3 months and during the study
Treatment with drugs that affect the immune system within the past 3 months and during the study
Treatment with topical steroids and calcineurin inhibitors 1 week before and during the study treatment period
Treatment with systemic steroids within the past month and during the study
Use of disinfectant soaps within 1 week before screening and during the study treatment period