Patients with mild to moderate atopic dermatitis MedDRA version: 19.0 Level: HLT Classification code 10012435 Term: Dermatitis and eczema System Organ Class: 100000004858
Conditions
Sponsors
Cutanea Life Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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, hematology, blood chemistry, virology and urinalysis; 2. AD diagnosis confirmed; 3. Symptoms present for at least 1 year; 4. EASI between 7.1 - 50.0, inclusive at screening; 5. 2-20% body surface area (BSA) affected at screening; 6. Body mass index (BMI) between 18 and 35 kg/m2, inclusive, and with a minimum weight of 50 kg; 7. Able to participate and willing to give written informed consent and to comply with the study restrictions; 8. Subjects and their partners of childbearing potential must use effective contraception, for the duration of the study and for 3 months after the last dose. 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 80 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Any current and / or recurrent clinical significant skin condition other than AD; 2. Pregnant, a positive pregnancy test, intending to become pregnant, or breastfeeding; 3. Ongoing use of prohibited atopic dermatitis treatments. Washout periods prior to baseline (first dose of the study drug) are as follows: a. Cyclosporine/oral steroids/azathioprine/mycophenolate mofetil/other systemic immunosuppressants: 4 weeks b. Phototherapy: 3 weeks c. Biologics: 5 half-lives of the drug d. 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. Known hypersensitivity to the compound or excipients of the compound or known hypersensitivity to one or more different 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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective - To assess efficacy and pharmacodynamic effects of topical omiganan BID ;Secondary Objective: Secondary objectives - To assess safety and tolerability of topical omiganan BID lesions ;Timepoint(s) of evaluation of this end point: - Biopsies are taken on day 0 and 28 (EOT) - Swabs; TEWL; TAP; Thermography; clinical assessments; standardized photos and questionnaires are taken on each visit; days 0,7,14,21,28,35 and 42.;Primary end point(s): Pharmacodynamic endpoints Pharmacodynamic effects of Omiganan will be assessed at the time points indicated in the Visit and Assessment Schedule (Table 1) by: - Local (biopsy) biomarkers (IFN-alpha, IFN-gamma, IL 6, IL13, IL31, eotaxin3) - Microbiome of skin lesions (in comparison to non-lesional skin) - Bacterial colonization of skin lesions (S. aureus) - Transepidermal water loss of lesional and non-lesional skin - Transdermal analysis patch (TAP) biomarkers: IFN-gamma, IL-6, IL-10, IL-13, IL-31, eotaxin3. - Circulating cytokines (TARC, IFN-alpha, IFN-gamma, IL 6, IL13, IL31, eotaxin3) - Thermography Efficacy endpoints Efficacy will be assessed at the time points indicated in the Visit and Assessment Schedule (Table 1) by: - Clinical assessment using oSCORAD; EASI - Patient-reported itch (daily NRS and weekly POEM) - General clinical assessment - Standardized total body clinical photography - Diary for drug compliance and use of escape medication - Partial / complete clearance of AD lesions | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Tolerability / safety endpoints Adverse events (AE) will be collected throughout the study, at every study visit. Laboratory safety testing, 12-Lead ECGs and vital signs will be performed and measured multiple times during the course the study according to the Visit and Assessment Schedule. Pharmacokinetic endpoints Following PK samples will be analyzed: - Day 28; Pre-dose, 10, 20, 30, 60, 120 and 180 minutes ;Timepoint(s) of evaluation of this end point: -Adverse events (AE) will be collected throughout the study, at every study visit. Laboratory safety tests will be performed at time of screening and at End-of-Study. Vital signs will be measured at baseline and days 0, 7, 14, 21, 28, 35, and 42. 12-Lead ECGs will be performed at screening and End-of-Study. Following PK samples will be analyzed: - Day 28; Pre-dose, 10, 20, 30, 60, 120 and 180 minutes | — |
Countries
Netherlands
Contacts
Public ContactJ. Burggraaf
Centre for Human Drug Research
Outcome results
None listed