A phase I/IIa, single-centre, randomized, double-blind, placebo-controlled, parallel treated dose-ranging study with a safety run-in period to assess the safety and efficacy of topical XZ.700 in patients with mild to moderate atopic dermatitis

Completed

• Conditions: Atopic Dermatitis / Eczema; 10014982

• Registration Number: NL-OMON54877
• Lead Sponsor: Micreos Human Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 36

Inclusion Criteria

1. Male and female subjects with mild to moderate AD (IGA 2 or 3) 18 to 65
years (during covid-19 restriction period subjects will be included from 18 to
54 years of age inclusive) of age, inclusive. The health status is verified by
absence of evidence of any clinically significant active or uncontrolled
chronic disease other than AD that potentially may influence the adherence to
the study and/or assessments in the study, following a detailed medical history
and a complete physical examination including vital signs, 12-lead ECG,
hematology, blood chemistry, virology and urinalysis;
2. Diagnosed with AD according to the Hanifin criteria (Hanifin 1980);
3. Suitable target lesion (preferably the antecubital fossa) defined as an
eczema lesion of 0,5%*BSA*5% (excluding the face and hands) with at least mild
erythema and mild induration at screening and baseline day 1;
4. Target lesion is cultured positive for S. aureus on two consecutive
occasions during the screening period;
5. Extent of lesional, atopic dermatits affected skin for 1%*BSA*15%; at
screening and baseline (day 1);
6. Willing to refrain from washing the target lesion 12 hours before every
study visit that includes microbiology samples;
7. Willing to use microbiome friendly wash solution as provided by sponsor and
refrain from other products for washing from screening until end-of-study;
8. Willing to refrain from all topical products for lesional skin during the
treatment period;
9. 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;
10. Able to Participate and willing to give written informed consent and to
comply with the study restrictions;
11. Has the ability to communicate well with the Investigator in the Dutch
language.

Exclusion Criteria

1. Any current and / or recurrent clinically significant skin condition which
will interfere with the clinical findings of the study as assessed by the
investigator;
2. Ongoing use of prohibited atopic dermatitis treatments. Washout periods
prior to baseline (first dose of the study drug) are as follows:
- All atopic dermatitis lesions: any topical medication (prescription or
over-the-counter [OTC]): 14 days. For emollients target lesion only: 7 days. On
other atopic dermatitis lesions use of emollients is allowed, however must be
discontinued prior to Day 1.
- Cyclosporine/oral steroids/azathioprine/mycophenolate mofetil/other systemic
AD drugs: 4 weeks
- Phototherapy: 3 weeks
- Biologics: 5 half-lives of the drug
- Systemic antibiotics: 14 days
3. Tanning due to sunbathing, excessive sun exposure or a tanning booth within
3 weeks of enrolment and/or not willing to refrain from these during the study;
4. Known hypersensitivity to the investigational compound or its excipients;
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. Loss or donation of blood over 500 mL within three months (males) or four
months (females) prior to screening;
8. A positive drug and/or alcohol test at screening (rescreening is allowed).
9. Subject has a body temperature of >38.0 °C at any visit, only during
SARS-CoV-2 measures;
10. Only during SARS-CoV-2 measures: Subject has a BMI of >30 kg/m2

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Tolerability / safety endpoints<br /><br>- Adverse events (AE)<br /><br>- Laboratory safety testing (blood and urine)<br /><br>- 12-Lead ECGs<br /><br>- Vital signs<br /><br>- Physical examination<br /><br>- Skin irritation by local irritation grading scale (Part A only)<br /><br><br /><br>Adherence<br /><br>* Electronic diary with photo capture function to monitor treatment compliance </p><br>