A Phase 2 Dose Ranging, Evaluator-Blinded Study to Evaluate the Safety of Topical IDP-118
Status: | Completed |
---|---|
Conditions: | Psoriasis |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 3/30/2013 |
Start Date: | June 2012 |
End Date: | July 2013 |
Contact: | Kathleen Smith, MBA |
Email: | ksmith@dowpharmsci.com |
Phone: | 707-793-2600 |
Subjects with a clinical diagnosis of plaque psoriasis with 10% to 20% of body surface area
affected will be enrolled in the study.
Approximately 60 subjects with a clinical diagnosis of moderate or severe psoriasis (defined
as at least of 10 % - 20% treatable Body Surface Area (BSA) and an Investigator's Global
Evaluation (IGE) of 3 or 4 at baseline (moderate or severe) will be enrolled in the study.
Inclusion Criteria:
- Male or female of any race, 18 to 65 (inclusive) years of age.
- Freely given verbal and written informed consent obtained from the subject.
- Clinical diagnosis of psoriasis at the Screening and Baseline visits with
- At least 10% - 20% of total treatable BSA involvement, and
- an Investigator's Global Evaluation score of 3 or 4 ( moderate or severe) on a scale
of 0 to 5
- Good general health as determined by the Investigator based on the subject's medical
history and physical examination, with Screening hematology, serum chemistry, and
urinalysis laboratory values within normal range limits.
Exclusion Criteria:
- Presence of psoriasis that was previously treated with prescription medication prior
to the Screening visit and is non-responsive to corticosteroid treatment, as
determined by the Investigator.
- Presence of any concurrent skin condition that could interfere with the evaluation of
the study drug, as determined by the Investigator.
- History of adrenal disease
- Female who is pregnant, nursing an infant, or planning a pregnancy during the study
period.
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