A study of the effects of a new drug (DLQ02) for the treatment of psoriasis

INTERVENTION: This randomized, double‐blind, vehicle‐controlled trial with safety run‐in (part A) will investigate the safety, tolerability and efficacy of DLQ02, over four weeks to patients with plaque psoriasis. 12 patients with plaque psoriasis will complete part A (safety run‐in) of the study and 24 plaque psoriasis patients will complete part B of the study. Each subject will be randomly allocated to receive DLQ02 high dose, low dose, or the matching vehicle. In part A the subjects will dose the topical formulation on the psoriasis target lesion for 4 weeks. Furthermore a non‐lesional part of the back will be dosed by the physician for the first 7 days. In part B of the study the subjects will dose with the topical/fluid formulation for 4 weeks on all psoriasis lesions (with a maximum of 2.5% BSA). 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. CONDITION: Treatment for plaque psoriasis patients. ; Skin and Connective Tissue Diseases PRIMARY OUTCOME: 1. Target lesions scoring using PASI (part B) and target lesion total signs; erythema, induration and scaling at baseline and study visits (daily visits for one week followed by 1 visit per week for 4 weeks); 2. Patient reported itch as measured using NRS at baseline and at study visits; 3. Diary as collected through eDiary at baseline and at study visits; 4. Lesion size measured and documentation with 2D photography at baseline and study visits. ; 5. Lesion size measured using 3D photography at baseline and study visits.; 6. Skin morphology using Optical Coherence Tomography at baseline and study visits. ; 7. Laser speckle contrast imaging at baseline and study visits. ; 8. Local irritation as measured using local irritation grading score (LIGS) at baseline and at study visits. SECONDARY OUTCOME: Pharmacokinetic endpoints at baseline and at study visits (daily visits for one week followed by 1 visit per week for 4 weeks):; 1. Cutaneous DLQ02 in skin biopsies.; 2. Systemic levels of DLQ02.; ; Pharmacodynamic and efficacy endpoints at baseline and at study visits; 1. Severity of psoriasis target lesion using clinical assessments.; 2. Percent of patients achieving clinical scores of clear of almost clear.; 3. Score of individual symptoms of the target lesion; 4. Patient reported outcomes of the target lesion; Target lesion area assessed with:; 5. 2D photography; 6. 3D photography; 7. Optical coherence tomography (OCT); 8. Laser speckle contrast imaging (LSCI) INCLUSION CRITERIA: 1. Males or non‐pregnant, non‐lactating females. 2. At least 18 years of age at time of consent. 3. Have stable psoriatic plaque psoriasis (for 6 months), as confirmed by the patient. 4. Have a maximum (treatable) BSA of 2.5%(only part B). 5. Have a target plaque (area) suitable for treatment 15cm2and =100cm2 with a severity defined by TSS score = 4, with at least a clinical score of = 2 for either erythema or induration and =1 for the symptom scaling. 6. Able and willing to follow instructions and comply with the study restrictions, including participation in all trial assessments and visits. 7. Provide written informed consent. 8. Willing to refrain from medications for psoriasis according to the wash‐out periods. 9. Patients and their partners of childbearing potential must use effective contraception, for the duration of the study and for 3 months after the last dose.