A randomized, double-blind, placebo controlled study to assess the pharmacodynamics, safety/tolerability and efficacy of omiganan in patients with mild to moderate atopic dermatitis - Pharmacodynamics of omiganan in patients with atopic dermatitis

Cutanea Life Sciences0 sitesStarted: April 2, 2015Last updated: December 7, 2015

Conditions

Trial Snapshot

No summary available.

•1. Male and female subjects with mild to moderate AD 18 to 65 years of age, inclusive. The health status is verified by absence of evidence of any clinical significant active or uncontrolled chronic disease other than AD following a detailed medical history, a complete physical examination including vital signs, 12-lead ECG, haematology, blood chemistry, and urinalysis. In the case of uncertain or questionable results, tests performed during screening may be repeated before randomization to confirm eligibility or judged to be clinically irrelevant for healthy subjects.
•2. AD diagnosed by physician / medical specialist and that has been present for at least 1 year
•3. At least one of the antecubital fossae must have an affected body surface area (BSA) of 0.5% with active dermatitis characterized by erythema and squamae at screening and end of the run-in period
•4. Pruritus VAS score of target lesion of =30 at screening and end of the run-in period
•5. oSCORAD-score of total body =40.
•6. 2-15% body surface area (BSA) involved with AD lesions at screening.
•7. Able to participate and willing to give written informed consent and to comply with the study restrictions.
•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 35
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 1

•1. Have any current and / or recurrent clinically significant skin condition in the treatment area other than AD.
•2. Subjects and their partners of childbearing potential must use two methods of contraception, one of which must be a barrier method for the duration of the study and for 3 months after the last dose.
•3. A washout period for the following medications:
•a. Cyclosporine/oral steroids/azathioprine/mycophenolate mofetil/other systemic immunosuppressants: 4 weeks
•b. Phototherapy: 3 weeks
•c. Topical calcineurin-inhibitors: 10 days
•4. Use of topical medication (prescription or over-the-counter [OTC]) within 14 days of study drug administration, or less than 5 half-lives (whichever is longer) in local treatment area
•5. Tanning due to sunbathing, excessive sun exposure, or a tanning booth within 3 weeks of enrollment.
•6. Any confirmed, active significant allergic reactions (urticaria or anaphylaxis) including allergic reactions against any drug, multiple drug allergies or (ingredients of) emollients.
•7. Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year.
•8. Loss or donation of blood over 500 mL within three months (males) or four months (females) prior to screening.
•9. Unwillingness or inability to comply with the study protocol for any other reason

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