Topically Applied IDP-118 Lotion and HP Monad Lotion in Subjects With Moderate to Severe Plaque Psoriasis

Study Overview
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Brief Summary
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Suppression Potential of Topically Applied IDP-118 Lotion and HP Monad Lotion in Subjects with Moderate to Severe Plaque Psoriasis.

Detailed Description
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A Phase 1b Open-Label, Randomized Study Evaluating the Absorption and Systemic Pharmacokinetics and HPA Axis Suppression Potential of Topically Applied IDP-118 Lotion and HP Monad Lotion in Subjects with Moderate to Severe Plaque Psoriasis.

Official Title
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A Phase 1b Open Label, Randomized Study Evaluating the Absorption and Systemic Pharmacokinetics and HPA Axis Suppression Potential of Topically Applied IDP-118 Lotion and HP Monad Lotion in Subjects With Moderate to Severe Plaque Psoriasis

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: IDP-118 Lotion
* Drug: HP Monad Lotion
* Drug: Ultravate Cream
* Drug: Tazorac Cream


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or Female of any race, at least 18 years old of age (inclusive) Freely provides both written and oral informed consent. Has a clinical diagnosis of psoriasis at the Baseline visit with an Investigator's Global Assessment Score of 3 or 4. The face, scalp ,axillae, and intertriginous areas are to be excluded in this calculation. Has an area of plaque psoriasis for topical treatment that involves a BSA of at least 20%. The willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study. Key Exclusion Criteria: Has spontaneously improving or rapidly deteriorating plaque psoriasis or postural psoriasis, as determined by the investigator. Presents with psoriasis that was treated with prescription medication and failed to respond to presents). Has a history of adrenal disease. Presents with any other concurrent skin conditions that could interfere with the evaluation of the treatment areas, as determined by the investigator. Is pregnant, nursing, or planning pregnancy during the study period.

Ages Eligible for Study
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Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IDP-118 Lotion<br>8 Weeks | Drug: IDP-118 Lotion<br>* Lotion<br>* Other names: Lotion;|
| Experimental: HP Monad Lotion<br>8 Weeks | Drug: HP Monad Lotion<br>* Lotion<br>* Other names: Lotion;|
| Active Comparator: Ultravate Cream<br>2 Weeks | Drug: Ultravate Cream<br>* Cream<br>* Other names: Ultravate;|
| Active Comparator: Tazorac Cream<br>4 Weeks | Drug: Tazorac Cream<br>* Cream<br>* Other names: Taz;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local Skin Reactions (LSRs) | Tolerability will be evaluated through assessment of local signs and symptoms (itching, dryness, burning/stinging) on a scale of non, mild, moderate, and severe. | 8 Weeks |