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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up three months after study end
Awards & highlights
Study Summary
This trial assesses a potentially new treatment for psoriasis. It aims to see if it's safe and helpful in controlling the symptoms.
Who is the study for?
Adults over 18 with mild to moderate chronic plaque psoriasis, who can consent and follow the study schedule. Women must use effective contraception. Excludes pregnant or breastfeeding women, those with serious illnesses like heart disease, uncontrolled bleeding, recent strokes, certain infections (HIV/HBV/HCV/TB), and those on conflicting medications.Check my eligibility
What is being tested?
The trial is testing SFA002 combined with Vitamin D, Magnesium and Propionate for safety and effectiveness in treating mild to moderate psoriasis plaques. The goal is to control symptoms of this common skin disorder as there's no cure.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include typical drug reactions such as skin irritation at the application site, allergic reactions, gastrointestinal issues or changes in blood levels of vitamin D and magnesium.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ three months after study end
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~three months after study end
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Psoriasis Area and Severity Index (PASI) Score
Trial Design
2Treatment groups
Experimental Treatment
Group I: Drug (SFA002) Vitamin D, Magnesium and PropionateExperimental Treatment1 Intervention
Drug (SFA002) 1000 mg, Propionate 150 mg, 80 mg Calcium, 40 mg Magnesium 3 times daily after meals and Vitamin D 1000 mg once daily
Group II: Drug (SFA002) Vitamin D, MagnesiumExperimental Treatment1 Intervention
Drug (SFA002) 1000 mg, 80 mg Calcium, 40 mg Magnesium 3 times daily after meals and Vitamin D 1000 IU once daily
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Who is running the clinical trial?
SFA TherapeuticsLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I understand the study details and am willing to sign the consent form.I have high blood pressure or severe peripheral vascular disease.I have stopped using certain psoriasis medications as required before starting this study.I have not had an abdominal fistula, GI perforation, or abscess in the last 6 months.I have risk factors for a specific heart rhythm problem.My psoriasis significantly worsened in the last 3 months.I experience shortness of breath with little activity and need frequent fluid drainage.I am using effective birth control or will for 3 months after the study ends.I have a skin condition like eczema or a skin infection.I have a tumor or cancer spread to my brain or spinal cord.I do not have serious heart or severe lung conditions that could make treatment risky for me.I have not had any uncontrolled bleeding or bleeding disorders in the last 6 months.I avoid direct sunlight on the skin areas being studied.I have diabetes, but it's not insulin-dependent and my A1c is under 8%.I do not have severe nerve pain or damage.I have had a stroke or a similar event in the last year.I have a serious or non-healing wound, skin ulcer, or bone fracture.I have HIV, hepatitis B or C, or active/latent TB.I am over 18 and have a psoriasis plaque larger than 5 cm2, diagnosed as mild to moderate.My psoriasis is not the chronic plaque type and has flared up within the last 3 months.I may or may not have received treatments like phototherapy for my psoriasis.I have not had a serious infection in the last month.
Research Study Groups:
This trial has the following groups:- Group 1: Drug (SFA002) Vitamin D, Magnesium
- Group 2: Drug (SFA002) Vitamin D, Magnesium and Propionate
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent is the enrollment for this research project capped?
"Affirmative. Clinicaltrials.gov hosts information which affirms that this investigation is currently recruiting participants, having been posted on March 31st 2022 and most recently altered on December 5th 2022. 30 individuals are being considered between two medical centres."
Answered by AI
Are new participants still being accepted for this research endeavor?
"Affirmative. According to information accessible on clinicaltrials.gov, this medical trial is currently recruiting patients who were first notified of the opportunity on March 31st 2022 and was last updated December 5th 2022. 30 individuals across 2 locations are needed for successful completion of the study."
Answered by AI
Has the FDA sanctioned Drug (SFA004) containing Vitamin D, Magnesium and Propionate?
"The safety profile of Drug (SFA004) Vitamin d, Magnesium and Propionate was rated a 1 since Phase 1 trials are limited in their ability to report on efficacy or safety."
Answered by AI
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