DLQ03 in a wound healing model in patients with atopic dermatitis (eczema)

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2022
INTERVENTION: This phase I/II randomized, assessor‐blind, vehicle‐controlled study will 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. All treatments are packaged similarly to ensure double blind randomization. Based on the assigned treatment, each subject will be randomly allocated to receive a single/multiple dose in either part A of part B of the study. Each subject will receive one of the following treatments: ‐ DLQ03 high dose ‐ DLQ03 low dose ‐ Vehicle control Randomization is performed 1:1:1 for the three treatments. The randomization code is generated by an uninvolved statistician using SAS Software and stored in sealed envelopes in a fireproof cabinet. Administration is performed topically on allocated target areas. Participants are followed up daily for one week. CONDITION: Treatment of skin and soft tissue infections ; Skin and Connective Tissue Diseases PRIMARY OUTCOME: 1. Staph. Aureus load measured using Swabs at baseline and at study visits (daily for one week). ; 2. Wound size measured using calliper and 3D imaging at baseline and at study visits; 3. Suction blister fluid at baseline and at study visits; 4. Laser Speckle Contract Imaging at baseline and at study visits; 5. Transepidermal water loss measured with TEWL at baseline and at study visits; 6. Thermography using infrared thermography at baseline and at study visits.; 7. Skin morphology using Optical coherence tomography at baseline and at study visits SECONDARY OUTCOME: 1. Local irritation as measured using local irritation grading score (LIGS) at baseline and at study visits.; 2. Target lesions scoring using oSCORAD, EASI, target lesion total signs and symptoms and surface area at baseline and study visits; 3. Patient reported itch as measured using NRS at baseline and at study visits; 4. Diary as collected through eDiary at baseline and at study visits 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 lesi
Epistemonikos ID: d397ce1812d710238fcdf5e66df6d298b4b53bc7
First added on: Aug 25, 2024