A Study to Investigate the Efficacy and Safety Profile of GM-XANTHO [GM-XAN003] in Patients With … (NCT06620692) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Study to Investigate the Efficacy and Safety Profile of GM-XANTHO [GM-XAN003] in Patients With Psoriasis
65 participantsStarted 2026-10-01
Plain-language summary
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.
Who can participate
Age range
20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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).
. The severity of plaque psoriasis is stable mild to moderate which meets the following disease activity criteria at both Screening and Baseline Visit (according to Joint AAD-NPF Guidelines)
. Patients who agree discontinuation of systemic corticosteroids and systemic immune modulating agents during the study period.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline in Psoriasis Area and Severity Index (PASI)
Timeframe: through study completion, an average of 7 weeks
. Patients who agree discontinuation of all local treatment modalities, including but not limited to topical corticosteroid or light treatments during the study period for/on the affected regions.
. Patients are required to stop using treatment modalities listed in Criteria #6 and #7 at least 14 days (or longer if the treatment half-life requires so; 7 half-life should have elapsed).
Exclusion criteria
. Patients with the following subtype of psoriasis
. Patients who have any concurrent skin condition that will interfere with assessment of treatment.
. Patients who have systemic infection during the last 2 weeks prior to Screening Visit or active infection on the psoriasis lesion.
. Patients who have known hypersensitivity to the study medication.
. Patients with chronic condition(s) which either is not stable or not well controlled.
. Patients having positive results for HBV, HCV or HIV screens.
. Patients who are pregnant or breast feeding.
. Patients who have the medical history of malignancy of any organ system (other than cervical carcinoma in situ or successfully treated non-melanoma skin cancer) within 5 years prior to study entry.