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

Study Overview
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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.

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.

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

Conditions
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Plaque Psoriasis

Intervention / Treatment
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* Drug: IDP-118 Low Strength
* Drug: IDP-118 High Strength


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IDP-118 Low Strength<br>IDP-118 Low Strength | Drug: IDP-118 Low Strength<br>* 8 weeks<br>* Other names: IDP-118;|
| Experimental: IDP-118 High Strength<br>IDP-118 High Strength | Drug: IDP-118 High Strength<br>* 8 weeks<br>* Other names: IDP-118;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of HPA axis suppression after treatment with investigational drug product and the comparators | To measure the incidence of HPA axis suppression after treatment with investigational drug product and the comparators | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and cutaneous tolerability of the two formulations and the comparators | To evaluate and Local Skin Reactions: Tolerability will be evaluated through assessment of selected local signs and symptoms at the drug-application site: itching, dryness, burning and stinging. In addition the treatment areas will be examined at each visit for significant known drug-related AEs such as skin atrophy, striae, telangiectasia and folliculitis. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psoriasis