Clinical trial NCT01670513: A Phase 2 Dose Ranging, Evaluator-Blinded Study to Evaluate the Safety of Topical IDP-118
Official title: A Phase 2 Dose Ranging, Evaluator-Blinded Study to Evaluate the Safety of Topical IDP-118
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Plaque Psoriasis
Keywords: Psoriasis
Lead sponsor: Dow Pharmaceutical Sciences
Sponsor class: INDUSTRY
First posted: 2012-08-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility 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.

Primary outcomes:
measure: The incidence of HPA axis suppression after treatment with investigational drug product and the comparators
timeFrame: 8 weeks
Secondary outcomes:
measure: To evaluate the safety and cutaneous tolerability of the two formulations and the comparators
timeFrame: 8 weeks
Other outcomes:
measure: To evaluate efficacy, defined as reduction of severity of disease in a sample target plaque during the course of the study
timeFrame: 8 weeks
Locations:
city: Santa Rosa
country: United States
facility: Dow Clinical Study Site
state: California
city: Clinton Township
country: United States
facility: Dow Clinical Study Site
state: Michigan
city: Fort Gratiot
country: United States
facility: Dow Cliincal Study Site
state: Michigan
city: Nashville
country: United States
facility: Dow Clinical Study Site
state: Tennessee
city: Austin
country: United States
facility: Dow Clinical Study Site
state: Texas
city: Norfolk
country: United States
facility: Dow Clinical Study Site
state: Virginia
Study officials:
affiliation: Medical Monitor
name: Todd Plott, MD
role: STUDY_DIRECTOR
References: