A Study to Investigate the Efficacy and Safety Profile of GM-XANTHO [GM-XAN003] in Patients with Psoriasis

ConditionPsoriasis
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age20+
SponsorXantho Biotechnology Co., LTD

About this trial

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.

Eligibility criteria

Qualifiers

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).

Disqualifiers

Erythrodermic psoriasis

Generalized or localized pustular psoriasis,

edication-induced or medication-exacerbated psoriasis,

New onset guttate psoriasis.

Trial design

Treatments tested in this trial

  • 5% GM-XANTHO [GM-XAN003]
  • Placebo

Treatment groups

65 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Xantho Biotechnology Co., LTD

Lead sponsor

Virginia Contract Research Organization Co., Ltd.

Collaborator