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.

Recruiting

Conditions: Eczema (atopic dermatitis)

Registration Number: NL-OMON24034

Lead Sponsor: Micreos Human Health

Brief Summary: .A.

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

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 65 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.

Exclusion Criteria

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 enrollment
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 (including this study) 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.