This trial is a Phase IIa clinical trial. Around 65 subjects will be enrolled into this study to primarily assess the treatment efficacy of 5% GM-XANTHO in patients with psoriasis, as well as the safety and tolerability of 5% GM-XANTHO. Two third of the total subjects will be given the investigational product, 5% GM-XANTHO, and the other third will take placebo. The treatment period will last for 28 consecutive days, followed by a safety follow-up for 2 weeks. During the study, there will be 8 scheduled visits to the clinical center.
Female or male patients are ≥ 20 years old.
Patients who are able to understand the nature of this study and accept to enter the study by signing written informed consent.
Patients are willing or able to comply with procedures required in this protocol including self-administration of study drug.
Patients who have well diagnosed chronic plaque psoriasis for at least 6 months before the Screening Visit (according to Am Fam Physician. 2013 May 1;87(9):626-633).
Patients with the following subtype of psoriasis
Erythrodermic psoriasis
Generalized or localized pustular psoriasis,
edication-induced or medication-exacerbated psoriasis,
Parallel
5% GM-XANTHO [GM-XAN003]
Drug5% GM-XANTHO \[GM-XAN003\]
Placebo
DrugThe placebo
Change from baseline in Psoriasis Area and Severity Index (PASI)
Change from baseline in Body Surface Area (BSA) affected
Change from baseline in quality of life by using the Dermatology Life Quality Index (DLQI)
Incidence of subjects experiencing treatment related AE with ≥ Grade 2 according to the predefined toxicity grading scale in this study
Number of patients achieving PGA of 0 or 1 at each visit
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Xantho Biotechnology Co., LTD
Lead sponsor
Virginia Contract Research Organization Co., Ltd.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
