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

Status unconfirmed · Phase 1/Phase 2

Conditions studied: Plaque Psoriasis

In brief

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

Key facts

Study ID

NCT01670513

Run by

Dow Pharmaceutical Sciences

People needed

60

Starts

2012-06-01

Expected to finish

2013-07-01

Last updated by the study team

2013-04-25

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Dow Clinical Study Site — Santa Rosa, California, United States
• Dow Clinical Study Site — Clinton Township, Michigan, United States
• Dow Cliincal Study Site — Fort Gratiot, Michigan, United States
• Dow Clinical Study Site — Nashville, Tennessee, United States
• Dow Clinical Study Site — Austin, Texas, United States
• Dow Clinical Study Site — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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