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2022-500647-21-00CompletedPhase 1/2

Study investigating the safety and efficacy of a new iodine formulation called DLQ03 in a wound-healing model in patients with atopic eczema

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

Source: EU CTIS (euclinicaltrials.eu) · Last updated 26 Jul 2023

Next steps

Brief summary (registry, in English)

To assess safety and local tolerability of DLQ03 in patients with atopic dermatitis

Status (registry)
Completed
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
27 (actual)
First submitted
2 May 2022
Start date
4 Aug 2022
Lead sponsor
Dermaliq Therapeutics Inc.
EU CT number
2022-500647-21-00

What you commit to

  • Study type: Interventional · Phase 1/2
  • Participants enrolled: 27
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Ongoing use of prohibited atopic dermatitis treatments. Washout periods prior to baseline (first dose of the study drug) are as follows:

Other illness

  • Any current and / or recurrent clinically significant skin condition which will interfere with the clinical findings of the study as assessed by the investigator.

Who the study is looking for

  • 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.
  • Diagnosed with AD according to the Hannifin criteria (Hannifin 1980
  • 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.
  • Target lesion is cultured positive for S. aureus on two consecutive occasions during the screening period:

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Centre for Human Drug ResearchLeidenNetherlandsCompleted

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This page is information, not medical advice. Discuss any trial with your doctor.