A Phase 2 Dose Ranging, Evaluator-Blinded Study to Evaluate the Safety of Topical IDP-118

• Status: Unknown status
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Subjects with a clinical diagnosis of plaque psoriasis with 10% to 20% of body surface area affected will be enrolled in the study.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dow Pharmaceutical Sciences

Criteria

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.