Phase II Study Evaluating the Clinical Efficacy and Safety of GN-037 in Plaque Psoriasis
Psoriasis
About this trial
This is an interventional treatment trial for Psoriasis focused on measuring mild to moderate plaque psoriasis, local treatment
Eligibility Criteria
Inclusion Criteria: Male and female patients between the ages of 18-65 Patients who can give their written informed consent prior to initiating any evaluation or procedure related to the study. Patients with negative SARS-CoV-2 PCR test result Patients who were diagnosed with mild or moderate plaque psoriasis at least 6 months ago by a dermatologist and whose diagnosis was confirmed according to the clinical judgment of the research physician at the time of enrollment. Patients with a Physician's Global Assessment (IGA) score of 3 or 4 at the screening visit [Face, scalp, palms, soles, armpits, and intertriginous areas will be excluded from this assessment] Patients with plaque psoriasis lesions covering a body surface area (BSA) of at least 3% to 12% [Face, scalp, palms, soles, axillae, and intertriginous areas will be excluded from this assessment.] Patients who received the last psoriasis treatment 4 weeks or before Patients who are confirmed to be healthy by medical history and physical examination and who do not have any clinically significant disease/condition other than plaque psoriasis that, at the discretion of the investigator, could affect the study evaluation. Patients who can protect the lesion areas from ultraviolet (UV) rays (natural or artificial) during the study Female patients: Patients who had a negative pregnancy test at the screening visit, did not breastfeed, did not plan pregnancy during the study, and agreed to use an effective method of contraception until the end of the study. Male patients: Patients who agreed to use an effective method of contraception for the duration of the study. Patients who can comply with all scheduled visits, laboratory tests, and other study procedures Patients with normal adrenocorticotropic hormone (ACTH) stimulation test Patients with normal dihydroepiandrostenedione sulfate (DHEAS) levels Exclusion Criteria: Patients with a known sensitivity/hypersensitivity to any component of the drugs to be used in the study Pregnant or lactating or female patients with a positive pregnancy test Patients who are resistant/unresponsive to corticosteroids Patients with psoriasis (eg guttate, erythrodermic, exfoliative or pustular) that, in the opinion of the investigating physician, resolves spontaneously or rapidly worsens Patients with other inflammatory skin disease (eg, atopic dermatitis, contact dermatitis, eczema, tinea corporis) that, in the opinion of the investigative physician, may affect study evaluations at the targeted treatment sites Patients who received phototherapy, photochemotherapy, systemic or local treatment for psoriasis or used systemic anti-inflammatory agents in the last 4 weeks Patients who received biologic therapy for psoriasis in the last 3 months Immunosuppressive or immunocompromised patients (patients who have taken immunosuppressive drugs in the last 2 months will also be excluded) Patients who have received any cancer treatment in the last 1 year Patients with severe hypertension (systolic blood pressure [SBP] > 160 mmHg or diastolic blood pressure [DBP] > 100 mmHg) Patients who cannot comply with the study procedures/rules and cannot be in harmony with the research team Patients who have participated in another clinical trial in the last 2 months or who are taking part in another clinical trial concurrently Patients with a known abnormality of the hypothalamus-pituitary-adrenal axis (HPA axis) Patients using products containing dihydroepiandrostenedione (DHEA) or dihydroepiandrostenedione sulfate (DHEAS) in the last 1 month
Sites / Locations
- Ankara Etlik City HospitalRecruiting
- Balıkesir University Health Practice and Research HospitalRecruiting
- Uludag University Faculty of MedicineRecruiting
- Pamukkale University Faculty of Medicine HospitalRecruiting
- Ataturk University Research HospitalRecruiting
- Istanbul University Cerrahpasa Faculty of MedicineRecruiting
- Basaksehir Cam and Sakura City HospitalRecruiting
- Bezmialem Vakif University Faculty of MedicineRecruiting
- Haydarpasa Numune Training and Research HospitalRecruiting
- Istanbul Haseki Training and Research HospitalRecruiting
- Istanbul University Istanbul Faculty of MedicineRecruiting
- University of Health Sciences Bakırkoy Dr. Sadi Konuk Training and Research HospitalRecruiting
- İzmir Democracy University Buca Seyfi Demirsoy Training And Research HospitalRecruiting
- Erciyes University Faculty of MedicineRecruiting
- Necmettin Erbakan University Meram Faculty of Medicine HospitalRecruiting
- Mersin University HospitalRecruiting
- Samsun Ondokuz Mayis University Faculty of MedicineRecruiting
- Uşak Training and Research HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Placebo Comparator
GN-037 cream
Clobetasol 17-propionate
Placebo
Psoriatic patients will receive GN-037 cream in 2:2:1 ratio Psoriatic patients will receive GN-037 cream twice daily on a selected body target lesion GN-037 cream will be applied as a thin film layer for 4 weeks.
Clobetasol 17-propionate cream will be applied in 2:2:1 ratio Psoriatic patients will receive clobetasol 17-propionate cream twice daily on a selected body target lesion Clobetasol 17-propionate will be applied as a thin film layer for 4 weeks.
Placebo cream will be applied in 2:2:1 ratio Psoriatic patients will receive placebo cream twice daily on a selected body target lesion Placebo cream will be applied as a thin film layer for 4 weeks.