Phase
Condition
Warts
Rosacea
Rash
Treatment
SFA002
Drug (SFA002) Vitamin D, Magnesium and Propionate
Drug (SFA002) Vitamin D, Magnesium
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subjects of both sexes ≥18 years of age with at least one skin plaque that is >5 cm2due to known psoriasis considered clinically to be MILD to MODERATE or MODERATE toSEVERE during evaluation and diagnosis at least 1 year prior. Mild is defined as "Just detectable to mild thickening; pink to light red coloration; predominantlyfine scaling", whereas moderate is defined as "Clearly distinguishable to moderatethickening; dull to bright red, clearly distinguishable to moderate thickening;moderate scaling".
Have or have not been treated with phototherapy, systemic therapy, or othertherapies for their psoriasis
Women of child-bearing potential (i.e., women who are pre-menopausal or notsurgically sterile) must use effective contraceptive methods (such as abstinence,intrauterine device (IUD), or double barrier device) during the study and for atleast 3 months following completion of the study.
Mentally competent, able to understand and willingness to sign the Informed ConsentForm (ICF).
Able to undergo the investigations and to follow the visit schedule stated in thestudy protocol.
Exclusion
Exclusion Criteria:
The forms of psoriasis other than chronic plaque psoriasis (such as drug-inducedpsoriasis or guttate, erythrodermic, or pustular psoriasis) or if the psoriasis doesnot meet the criterion of chronicity (defined as a clinically significant flare ofpsoriasis within 12 weeks before baseline).
Presence of other form of inflammatory skin diseases (such as atopic dermatitis) orinfectious 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 "significantflare" prior to study baseline is left to the investigators. The intent of thiscriterion was to ensure the condition is sufficiently stable and aligned with thechronic nature of plaque psoriasis, so that an adequate assessment of the efficacycould be made.)
Prior or current use of psoriasis medications that might confound assessment ofefficacy of the investigational supplements used in this study, unless there wereused before their washout period prior to study initiation (see Table 2 for specificmedications and their washout periods).
Known serious medical illness, such as significant cardiac disease (e.g.,symptomatic congestive heart failure, unstable angina pectoris, symptomatic coronaryartery disease, myocardial infarction within the past 6 months, uncontrolled orsymptomatic cardiac arrhythmia, or New York Heart Association Class III or IV), orsevere 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., clinicallysignificant heart failure, hypokalemia, family history of Long QT Syndrome).
Known to have arterial thrombotic event, stroke, or transient ischemia attack withinthe past 12 months.
Known to have uncontrolled hypertension (systolic blood pressure >160 mm Hg ordiastolic blood pressure >90 mm Hg), or peripheral vascular disease ≥grade 2.
Known to have active central nervous system (CNS), epidural tumor or metastasis, orbrain metastasis.
Any active uncontrolled bleeding, a bleeding diathesis (e.g., active peptic ulcerdisease), or a history of bleeding (e.g., hemoptysis, upper or lowergastrointestinal [GI] bleeding) within the past 6 months.
Dyspnea with minimal to moderate exertion; large and recurrent pleural or peritonealeffusions requiring frequent drainage (e.g. weekly); or any amount of clinicallysignificant pericardial effusion.
Diabetes of any type, except Non-Insulin Dependent Diabetes Mellitus (NIDDM) that iscontrolled and with hemoglobin A1c 8%.
Evidence of active infection during screening, or serious infection within the pastmonth.
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 6months.
Neuropathy of grade ≥2.
Pregnant or lactating females.
Patients like to purposely undergoing sunlight exposure, including the skin areawhere the plaques being investigated are located, during the study
Study Design
Study Description
Connect with a study center
NuLine Clinical Trial Center
Pompano Beach, Florida 33060
United StatesActive - Recruiting
Brock Clinical Research
Baltimore, Maryland 21237
United StatesSite Not Available
Axis Clincals USA
Fargo, North Dakota 58104
United StatesActive - Recruiting
Axis Clincals USA/ Red River Research Patners. LLC
Fargo, North Dakota 58104
United StatesActive - Recruiting
Temple University
Philadelphia, Pennsylvania 19140
United StatesActive - Recruiting
Tranquil Clinical Research
Webster, Texas 77158
United StatesSite Not Available
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