Loading clinical trials...

Study of SFA002 in Patients with Mild to Moderate Psoriasis Plaques | Clinical Trials | Clareo Health

RECRUITINGPHASE1

Study of SFA002 in Patients with Mild to Moderate Psoriasis Plaques

A Study of Improvement in Psoriasis Symptoms Associated with Combinations of Biologically Active Natural Substances (SFA-002) with Known Safety Profile

NCT05642182•SFA Therapeutics

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine the safety, metabolism and potential effect of drug product SFA-002 on mild moderate and severe chronic plaque psoriasis. Psoriasis is a common chronic skin disorder that affects over 4 million people. There is no cure for psoriasis and treatment is directed at controlling patients' symptoms.

Detailed Description

Up to ninety volunteers with mild to moderate chronic plaque psoriasis will be recruited for an open label 24 week prospective study of the safety of 2 different dosages for 12 weeks of active therapy and 12 weeks of follow up. Blood will be drawn to determine any clinical effect on each group at the 12 week time mark and residual effects after 24 weeks. Throughout the study the investigators will perform both clinical and laboratory assessments to measure safety and response.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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 Criteria

•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.
+9 more criteria

Locations (3)

NuLine Clinical Trial Center

Pompano Beach, Florida, United States

Axis Clincals USA/ Red River Research Patners. LLC

Fargo, North Dakota, United States

Temple University

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

March 31, 2022

Primary Completion Date

July 30, 2025

Completion Date

July 31, 2025

Last Updated

January 9, 2025

Enrollment

ESTIMATED participants

Conditions

Psoriasis

Interventions

SFA002

DRUG

SFA002

DRUG

Contacts

VP Development

CONTACT

267-625-4873 info@sfatherapeutics.com

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

NCT07449234

Psoriasis

View study

RECRUITINGPHASE3

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

NCT07116967

Plaque Psoriasis

View study

RECRUITINGPHASE3

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

NCT07250802

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 9, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study of SFA002 in Patients with Mild to Moderate Psoriasis Plaques

Inclusion Criteria

Exclusion Criteria

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis

Real-Life Evaluation of Guselkumab Dosing Interval Adjustments