Patients with mild to moderate atopic dermatitis. MedDRA version: 17.1 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 100000004858 MedDRA version: 17.1 Level: LLT Classification code 10003640 Term: Atopic dermatitis and related conditions System Organ Class: 100000004858
Conditions
Interventions
Product Name: Omiganan Topical Gel
Product Code: CLS001
Pharmaceutical Form: Gel
INN or Proposed INN: Omiganan Pentahydrochloride
CAS Number: 269-062-93-3
Current Sponsor code: CLS001
Concentration un
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, 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To explore the pharmacodynamic effects on a target lesion of topically applied omiganan in atopic dermatitis patients. ;Secondary Objective: To assess safety and tolerability in AD patients To evaluate treatment effect of omiganan compared to placebo in AD patients ;Primary end point(s): Pharmacodynamic effects of CLS001 on the target lesion will be assessed by: - Local (biopsy) biomarkers (IgE, IFN- ? IL-1b, IL4, IL-6, IL-8, IL-9, IL-10, IL-13, IL-18, IL-31, TARC, eotaxin, oncostatin, TLR-2, TSLP, fillagrin) - Microbiome of skin lesion - Bacterial colonization of skin lesions (S. aureus) including biomarkers (enterotoxins) - Transepidermal water loss of lesional and non-lesional skin ;Timepoint(s) of evaluation of this end point: - A biopsy is taken on day 0 and 28 (EOT) - Swabs are taken on each visit; days 0,1,3,7,14,21,28,35 and 42. - TEWL measurements are taken on each visit except on screening, day 3 and 35. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety end points 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 1, 3, 7, 14, 21, 28, 35, and 42. 12-Lead ECGs will be performed at screening and End-of-Study. Efficacy end points Change from baseline to each time point of measurement during each treatment period for the following assessments: - Clinical assessment of lesion on-site with local objective SCORAD and pruritus VAS - Lesion size and morphology assessment by standardized clinical photography and 3D photography; ;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 1, 3, 7, 14, 21, 28, 35, and 42. 12-Lead ECGs will be performed at screening and End-of-Study. Efficacy end points - Clinical assessment oSCORAD on every visit. - Clinicial assessment pruritus VAS continious from run-in period until EOT. - clinical photography on every visit except on day 1,3, and 35. | — |
Countries
Netherlands
Contacts
Public ContactJ. Burggraaf
Centre for Human Drug Research
Outcome results
None listed