A phase I/II randomized, assessor-blind, vehicle-controlled study to assess the safety, tolerability, and pharmacodynamics of DLQ03 in a wound healing model in patients with mild to moderate atopic dermatitis that are colonized with S. Aureus.

Dermaliq Therapeutics Inc.0 sites27 target enrollmentAugust 4, 2022

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Dermaliq Therapeutics Inc.
Enrollment: 27
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 4, 2022

End Date

November 21, 2023

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Dermaliq Therapeutics Inc.

Eligibility Criteria

Inclusion Criteria

•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 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 Hannifin criteria (Hannifin 1980\).
•3\. Suitable target lesion defined as an eczema lesion of at least 0\.5% BSA (excluding the face) at screening and baseline day 1 for part A and 2 suitable target lesions defined as two eczema lesions of at least 0\.5% BSA (excluding the face) at screening and baseline day 1 for part B. In Part B the location of one of the lesions must be such that suction blisters can be drawn on the lesion.
•4\. Target lesion is cultured positive for S. aureus on two consecutive occasions during the screening period:
•5\. Maximum 15% body surface area (BSA) affected at screening and baseline (day 1\).
•6\. Willing to refrain from washing the target lesion(s) at least 6 but preferably 12 hours before every study visit.
•7\. 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.
•8\. Able to participate and willing to give written informed consent and to comply with the study restrictions.
•9\. 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:
•2\.1\. Target lesions only: Any topical medication (prescription or over\-the\-counter \[OTC]) for 14 days)
•2\.2\. Cyclosporine/oral steroids/azathioprine/mycophenolate mofetil/other systemic AD treatments: 4 weeks
•2\.3\. Phototherapy: 3 weeks
•2\.4\. Biologics: 5 half\-lives of the drug
•2\.5\. Systemic antibiotics: 14 days
•3\. Tanning due to sunbathing, excessive sun exposure or a tanning booth within 3 weeks of enrollment and/or not willing to refrain from these during the study.
•4\. Part B only: Subject has a Fitzpatrick’s Skin Phototype \= 4\.
•5\. Begin treatment with systemic or locally acting medications which might counter or influence the study aim (e.g., medications which are known to provoke or aggravate atopic dermatitis).