A study to assess the effect and safety/tolerability of a locally applied gel in patients with mild to moderate atopic dermatitis
- Conditions
- Patients with mild to moderate atopic dermatitis.MedDRA version: 17.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858MedDRA version: 17.1Level: LLTClassification code 10003640Term: Atopic dermatitis and related conditionsSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2014-003689-26-NL
- Lead Sponsor
- Cutanea Life Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>To evaluate treatment effect of omiganan compared to placebo in AD patients <br>;Primary end point(s): Pharmacodynamic effects of CLS001 on the target lesion will be assessed by: <br>- 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)<br>- Microbiome of skin lesion<br>- Bacterial colonization of skin lesions (S. aureus) including biomarkers (enterotoxins)<br>- Transepidermal water loss of lesional and non-lesional skin<br>;Timepoint(s) of evaluation of this end point: - A biopsy is taken on day 0 and 28 (EOT)<br><br>- Swabs are taken on each visit; days 0,1,3,7,14,21,28,35 and 42.<br><br>- TEWL measurements are taken on each visit except on screening, day 3 and 35.
- Secondary Outcome Measures
Name Time Method