A randomized, double-blind, placebo controlled, single center study to assess the efficacy and pharmacodynamics of Gladskin eczema cream BID in patients with mild to moderate atopic dermatitis.
- Conditions
- Atopic Dermatitis / Eczema10014982
- Registration Number
- NL-OMON49563
- Lead Sponsor
- Micreos Human Health
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
For enrollment of subjects the following criteria must be met:
1. Male and female subjects with mild to moderate AD (IGA 2 or 3) 18 to 55
years of age, inclusive. The health status is verified by absence of evidence
of any clinically significant active or uncontrolled chronic disease other than
AD following a detailed medical history and a complete physical examination
2. Diagnosed with AD according to the Hanifin criteria
3. EASI *4
4. Suitable target lesion defined as an eczema lesion of at least 1% BSA
(preferably the antecubital fossa) with at least mild erythema and mild
induration
5. *5% body surface area (BSA) affected at screening and baseline
6. Willing to not wash the target lesion 12 hours before every study visit
7. Willing to use microbiome friendly wash solution and refrain from other
products for washing from screening until end-of-study
8. Able to participate and willing to give written informed consent and to
comply with the study restrictions
9. Has sufficient Dutch language skills to be able to communicate well with the
Investigator, understand the informed consent and complete questionnaires and
e-diary.
1. Any current and / or recurrent clinically significant skin condition other
than AD
2. Ongoing use of prohibited atopic dermatitis treatments. Washout periods
prior to baseline (first dose of the study medical device) are as follows:
a. Any topical medication (prescription or over-the-counter [OTC]): 14 days.
Continued use of emollients during wash-out is allowed.
b. Cyclosporine/oral steroids/azathioprine/mycophenolate mofetil/other systemic
AD treatments: 4 weeks
c. Phototherapy: 3 weeks
d. Biologics: 5 half-lives of the drug
e. Systemic antibiotics: 14 days
3. Tanning due to sunbathing, excessive sun exposure or a tanning booth within
3 weeks of enrolment
4. Known hypersensitivity to the compound or excipients of the compound
5. Pregnant, a positive pregnancy test, intending to become pregnant, or
breastfeeding;
6. Participation in an investigational drug or device study within 3 months
prior to screening or more than 4 times a year
7. Any (medical) condition that would, in the opinion of the investigator,
potentially compromise the safety or compliance of the patient or may preclude
the patient*s successful completion of the clinical trial.
8. Subject has a body temperature of >38°C at any visit;.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method