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New treatment option for Psoriasis
Official title Study of SFA002 in Patients with Mild to Moderate Psoriasis Plaques
ClinicalTrials.gov ID: NCT05642182
What this study is testing
What is SFA002?
SFA002 is an investigational medicine, being studied as a potential treatment for psoriasis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people 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...
- 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...
- 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.
You likely can't join if
- The forms of psoriasis other than chronic plaque psoriasis (such as drug-induced psoriasis or guttate, erythrodermic, or pustular psoriasis) or if...
- Presence of other form of inflammatory skin diseases (such as atopic dermatitis) or infectious diseases (such as cellulitis, warts, fungal cutaneous...
- A clinically significant flare of psoriasis within 12 weeks before baseline. (Note: The determination of whether prospective study participants had a...
- Prior or current use of psoriasis medications that might confound assessment of how well it works of the investigational supplements used in this...
- Known serious medical illness, such as significant cardiac disease (e.g., symptomatic congestive heart failure, unstable angina pectoris, symptomatic...
- Known to have a history of risk factors for torsade de pointes (e.g., clinically significant heart failure, hypokalemia, family history of Long QT...
See the full eligibility criteria
- people 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...
- 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...
- 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.
- 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...
- 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...
- Prior or current use of psoriasis medications that might confound assessment of how well it works of the investigational supplements used in this study, unless there were used before their washout period prior to study...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Pompano Beach, Florida, United States
- Fargo, North Dakota, United States
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pompano Beach, Florida, United States; Fargo, North Dakota, United States; Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.