Study of SFA002 for Mild to Moderate Psoriasis
This study is testing SFA002, a potential new treatment for mild to moderate plaque psoriasis (a common, chronic skin condition causing red, scaly patches). Researchers want to see how safe SFA002 is and if it helps improve psoriasis symptoms. You might be able to join if you are at least 18 years old and have mild to moderate plaque psoriasis that has been diagnosed for at least one year. The main way they will measure success is by looking at your Psoriasis Area and Severity Index (PASI) score, which measures how much your psoriasis has improved, over 24 weeks. The current status of this study is unclear, and it plans to enroll up to 90 participants.
- Study design
- This is an open-label study, meaning both you and the researchers will know which treatment you are receiving. It will involve up to 90 participants.
- What's involved
- You would receive active treatment for 12 weeks, followed by 12 weeks of follow-up. Blood draws and other clinical and laboratory assessments will be performed at 12 and 24 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 12 weeks after the 12-week treatment period, for a total of 24 weeks from enrollment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05642182
Study of SFA002 in Patients with Mild to Moderate Psoriasis Plaques
Recruiting
PHASE1Ages 18+InterventionalTreatmentSFA Therapeutics
~90 participants
Updated 2025-01-09 on ClinicalTrials.gov
What's tested:SFA002
At a glance
Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Psoriasis Area and Severity Index (PASI) Score
Measured over From enrollment to final visit at 24 weeks treatment and 4 week follow-up
Conditions
Where it's being run
3 sites across 3 statesFlorida1
North Dakota1
Pennsylvania1
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Subjects of both sexes ≥18 years of age with at least one skin plaque that is \>5 cm2 due to known psoriasis considered clinically to be MILD to MODERATE or MODERATE to SEVERE during evaluation and diagnosis at least 1 year prior. Mild is defined as "Just detectable to mild thickening; pink to light red coloration; predominantly fine scaling", whereas moderate is defined as "Clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling".
Have or have not been treated with phototherapy, systemic therapy, or other therapies for their psoriasis
Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use effective contraceptive methods (such as abstinence, intrauterine device (IUD), or double barrier device) during the study and for at least 3 months following completion of the study.
Mentally competent, able to understand and willingness to sign the Informed Consent Form (ICF).
Able to undergo the investigations and to follow the visit schedule stated in the study protocol.
Exclusion
The forms of psoriasis other than chronic plaque psoriasis (such as drug-induced psoriasis or guttate, erythrodermic, or pustular psoriasis) or if the psoriasis does not meet the criterion of chronicity (defined as a clinically significant flare of psoriasis within 12 weeks before baseline).
Presence of other form of inflammatory skin diseases (such as atopic dermatitis) or infectious diseases (such as cellulitis, warts, fungal cutaneous diseases, etc.)
A clinically significant flare of psoriasis within 12 weeks before baseline. (Note: The determination of whether prospective study participants had a "significant flare" prior to study baseline is left to the investigators. The intent of this criterion was to ensure the condition is sufficiently stable and aligned with the chronic nature of plaque psoriasis, so that an adequate assessment of the efficacy could be made.)
Prior or current use of psoriasis medications that might confound assessment of efficacy of the investigational supplements used in this study, unless there were used before their washout period prior to study initiation (see Table 2 for specific medications and their washout periods).
Known serious medical illness, such as significant cardiac disease (e.g., symptomatic congestive heart failure, unstable angina pectoris, symptomatic coronary artery disease, myocardial infarction within the past 6 months, uncontrolled or symptomatic cardiac arrhythmia, or New York Heart Association Class III or IV), or severe debilitating pulmonary disease, that would potentially increase subjects' risk for toxicity.
Known to have a history of risk factors for torsade de pointes (e.g., clinically significant heart failure, hypokalemia, family history of Long QT Syndrome).
Known to have arterial thrombotic event, stroke, or transient ischemia attack within the past 12 months.
Known to have uncontrolled hypertension (systolic blood pressure \>160 mm Hg or diastolic blood pressure \>90 mm Hg), or peripheral vascular disease ≥grade 2.
Known to have active central nervous system (CNS), epidural tumor or metastasis, or brain metastasis.
Any active uncontrolled bleeding, a bleeding diathesis (e.g., active peptic ulcer disease), or a history of bleeding (e.g., hemoptysis, upper or lower gastrointestinal \[GI\] bleeding) within the past 6 months.
Dyspnea with minimal to moderate exertion; large and recurrent pleural or peritoneal effusions requiring frequent drainage (e.g. weekly); or any amount of clinically significant pericardial effusion.
Diabetes of any type, except Non-Insulin Dependent Diabetes Mellitus (NIDDM) that is controlled and with hemoglobin A1c 8%.
Evidence of active infection during screening, or serious infection within the past month.
Patients with known Human Immunodeficiency Virus (HIV), hepatitis B or C virus (HBV) or (HCV), respectively), or active or latent Tuberculosis (TB).
Serious or non-healing wound, skin ulcer, or bone fracture.
Abdominal fistula, GI perforation, or intra-abdominal abscess within the past 6 months.
Neuropathy of grade ≥2.
Pregnant or lactating females.
Patients like to purposely undergoing sunlight exposure, including the skin area where the plaques being investigated are located, during the study
What this trial measures
- Psoriasis Area and Severity Index (PASI) ScoreFrom enrollment to final visit at 24 weeks treatment and 4 week follow-up
+/- % Change in Psoriasis (PASI) index from baseline measurement at first dose