Phase
Condition
Warts
Scalp Disorders
Rosacea
Treatment
Clobetasol 17-propionate
GN-037
Placebo
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Male and female patients between the ages of 18-65
- Patients who can give their written informed consent prior to initiating anyevaluation 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 monthsago by a dermatologist and whose diagnosis was confirmed according to the clinicaljudgment of the research physician at the time of enrolment.
- Patients with a Investigator Global Assessment (IGA) score of 2 or 3 at the screeningvisit [Face, scalp, palms, soles, armpits, and intertriginous areas will be excludedfrom 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 beexcluded 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 examinationand who do not have any clinically significant disease/condition other than plaquepsoriasis that, at the discretion of the investigator, could affect the studyevaluation.
- Patients who can protect the lesion areas from ultraviolet (UV) rays (natural orartificial) 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 aneffective method of contraception until the end of the study. Male patients: Patients who agreed to use an effective method of contraception for theduration of the study.
- Patients who can comply with all scheduled visits, laboratory tests, and other studyprocedures
- Patients with normal adrenocorticotropic hormone (ACTH) stimulation test
- Patients with normal dihydroepiandrostenedione sulfate (DHEAS) levels
Exclusion
Exclusion Criteria:
- Patients with a known sensitivity/hypersensitivity to any component of the drugs to beused 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, inthe opinion of the investigating physician, resolves spontaneously or rapidly worsens
- Patients with other inflammatory skin disease (eg, atopic dermatitis, contactdermatitis, eczema, tinea corporis) that, in the opinion of the investigativephysician, may affect study evaluations at the targeted treatment sites
- Patients who received phototherapy, photochemotherapy, systemic or local treatment forpsoriasis 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 takenimmunosuppressive 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 ordiastolic blood pressure [DBP] > 100 mmHg)
- Patients who cannot comply with the study procedures/rules and cannot be in harmonywith the research team
- Patients who have participated in another clinical trial in the last 2 months or whoare taking part in another clinical trial concurrently
- Patients with a known abnormality of the hypothalamus-pituitary-adrenal axis (HPAaxis)
- Patients using products containing dihydroepiandrostenedione (DHEA) ordihydroepiandrostenedione sulfate (DHEAS) in the last 1 month
Study Design
Study Description
Connect with a study center
Ankara Etlik City Hospital
Ankara,
TurkeySite Not Available
Balıkesir University Faculty of Medicine
Balıkesir,
TurkeySite Not Available
Balıkesir University Health Practice and Research Hospital
Balıkesir,
TurkeySite Not Available
Uludag University Faculty of Medicine
Bursa,
TurkeySite Not Available
Pamukkale University Faculty of Medicine
Denizli,
TurkeySite Not Available
Pamukkale University Faculty of Medicine Hospital
Denizli,
TurkeySite Not Available
Ataturk University Research Hospital
Erzurum,
TurkeySite Not Available
Hatay Mustafa Kemal University Faculty of Medicine Hospital
Hatay,
TurkeySite Not Available
Basaksehir Cam and Sakura City Hospital
Istanbul,
TurkeySite Not Available
Bezmialem Vakif University Faculty of Medicine
Istanbul,
TurkeySite Not Available
Haydarpasa Numune Training and Research Hospital
Istanbul,
TurkeySite Not Available
Istanbul Haseki Training and Research Hospital
Istanbul,
TurkeySite Not Available
Istanbul Umraniye Training and Research Hospital
Istanbul,
TurkeyActive - Recruiting
Istanbul University Cerrahpasa Faculty of Medicine
Istanbul, 34786
TurkeySite Not Available
Istanbul University Istanbul Faculty of Medicine
Istanbul,
TurkeySite Not Available
University of Health Sciences Bakırkoy Dr. Sadi Konuk Training and Research Hospital
Istanbul,
TurkeySite Not Available
Erciyes University Faculty of Medicine
Kayseri, 38110
TurkeySite Not Available
Necmettin Erbakan University Meram Faculty of Medicine
Konya,
TurkeySite Not Available
Necmettin Erbakan University Meram Faculty of Medicine Hospital
Konya,
TurkeySite Not Available
Mersin University Faculty of Medicine
Mersin,
TurkeySite Not Available
Mersin University Hospital
Mersin,
TurkeySite Not Available
Samsun Ondokuz Mayis University Faculty of Medicine
Samsun,
TurkeySite Not Available
Uşak Training and Research Hospital
Uşak,
TurkeySite Not Available
İzmir Democracy University Buca Seyfi Demirsoy Training And Research Hospital
İzmir,
TurkeySite Not Available
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