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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-07-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Plaque Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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IDP-118 Low Strength

Group Type EXPERIMENTAL

IDP-118 Low Strength

Intervention Type DRUG

8 weeks

IDP-118 High Strength

Group Type EXPERIMENTAL

IDP-118 High Strength

Intervention Type DRUG

8 weeks

Interventions

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IDP-118 Low Strength

8 weeks

Intervention Type DRUG

IDP-118 High Strength

8 weeks

Intervention Type DRUG

Other Intervention Names

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IDP-118 IDP-118

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No