Actively Recruiting

Phase 1
Age: 18Years +
All Genders
ID05642182

Study of SFA002, a Combination of Natural Substances, for Improving Symptoms in Mild to Moderate Psoriasis Plaques in Adults

Led by SFA Therapeutics · Updated on 2025-01-09

90

Participants Needed

3

Research Sites

174 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the safety, metabolism, and potential effects of the drug SFA-002 in adults with mild to moderate chronic plaque psoriasis, a common skin condition affecting over 4 million people. This Phase 1 open-label study aims to understand how SFA-002 may influence psoriasis symptoms, as there is currently no cure and treatment focuses on symptom control. Up to ninety participants will receive one of two dosages of SFA-002 for 12 weeks, followed by a 12-week follow-up period. The study uses two forms of SFA-002: one without excipient and one with propionate as an excipient. Blood samples and clinical assessments will be conducted at 12 weeks to evaluate effects, with further monitoring until 24 weeks to observe any lasting impacts. During the study, participants will undergo regular clinical and laboratory evaluations to monitor safety and response, including measurements of the Psoriasis Area and Severity Index (PASI) from enrollment through the final visit at 24 weeks and the 4-week follow-up. Researchers will track symptoms, metabolic changes, and any side effects throughout this period to assess the overall impact of SFA-002 treatment.

CONDITIONS

Official Title

Study of SFA002 in Patients with Mild to Moderate Psoriasis Plaques

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older with mild to moderate or moderate to severe chronic plaque psoriasis diagnosed at least 1 year prior
  • Have at least one skin plaque larger than 5 cm2
  • May or may not have been treated previously with phototherapy, systemic therapy, or other psoriasis treatments
  • Women of child-bearing potential must use effective contraception during the study and for 3 months after
  • Mentally competent and willing to sign informed consent
  • Able to follow study procedures and visit schedule
Not Eligible

You will not qualify if you...

  • Psoriasis types other than chronic plaque psoriasis, or recent significant flare within 12 weeks before baseline
  • Other inflammatory or infectious skin diseases
  • Use of psoriasis medications without completing required washout periods
  • Serious medical illnesses including significant cardiac or pulmonary disease
  • History of torsade de pointes risk factors
  • Stroke, transient ischemia, or arterial thrombotic events within past 12 months
  • Uncontrolled hypertension or peripheral vascular disease grade 2 or higher
  • Active central nervous system tumors or metastases
  • Active uncontrolled bleeding or recent bleeding history within 6 months
  • Dyspnea with minimal exertion or recurrent pleural/peritoneal effusions
  • Diabetes except controlled non-insulin dependent diabetes with A1c ≤8%
  • Active or recent serious infections or known HIV, hepatitis B or C, or tuberculosis
  • Serious or non-healing wounds, ulcers, or fractures
  • Recent abdominal fistula, gastrointestinal perforation, or abscess within 6 months
  • Neuropathy grade 2 or higher
  • Pregnant or lactating females
  • Intentionally exposing affected skin areas to sunlight during the study

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 3 locations

1

NuLine Clinical Trial Center

Pompano Beach, Florida, United States, 33060

Actively Recruiting

2

Axis Clincals USA/ Red River Research Patners. LLC

Fargo, North Dakota, United States, 58104

Actively Recruiting

3

Temple University

Philadelphia, Pennsylvania, United States, 19140

Actively Recruiting

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Research Team

V

VP Development

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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