ACTRN12617001178336
Terminated
Phase 1
A Phase 1, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of Topical SM04755 Solution Following Topical Administration to Subjects with Mild to Moderate Plaque Psoriasis
Samumed Pacific Pty Ltd0 sites13 target enrollmentAugust 10, 2017
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Samumed Pacific Pty Ltd
- Enrollment
- 13
- Status
- Terminated
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •BMI of 18 to 40, inclusive
- •\- Mild to moderate plaque psoriasis less than or equal to 10% body surface area
- •\- A single, non\-intertriginous lesion with target plaque area great than or equal to 30 and less than or equal to 60 cm2\.
- •\- Target Plaque Severity Score greater than or equal to 5 and less than or equal to 10 with Induration score greater than or equal to 2 and less than or equal to 4\.
- •\- Willing to avoid extensive sun exposure, phototherapy, or use of a tanning salon
- •\- Subject must read and understand the informed consent form, and sign it prior to any study\-related procedure being performed
- •\- Willingness to comply with all scheduled study visits, laboratory tests, contraception requirements, and other study procedures
- •\- Study cohort is open for randomization
Exclusion Criteria
- •\- Women who are pregnant or lactating.
- •\- Women of childbearing potential who are sexually active and are not willing to use birth control
- •\- Males who are sexually active and not willing to use a condom
- •\- History of allergy to investigational product/placebo ingredients
- •\- Recent use of any topical treatment for plaque psoriasis
- •\- Prior treatment with prescription medication for plaque psoriasis with no improvement in condition
- •\- Prior treatment of plaque psoriasis with biologic therapies
- •\- History of or current skin disease
- •\- History of clinically significant hematologic, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, musculoskeletal, immunologic, neurologic or dermatologic disease
- •\- History of malignancy within the last 5 years
Outcomes
Primary Outcomes
Not specified
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