Absorption and Systematic Pharmacokinetics of IDP-123 Lotion in Comparison With Tazorac Cream

Study Overview
=================
Brief Summary
-----------------
The Absorption and Systematic Pharmacokinetics of IDP-123 Lotion in Comparison with Tazorac Cream.

Detailed Description
-----------------
Randomized study evaluating the absorption and systematic pharmacokinetics of IDP-123 lotion in comparison with Tazorac Cream in subjects with moderate to severe acne vulgaris under maximal use conditions.

Official Title
-----------------
Randomized Study Evaluating the Absorption and Systematic Pharmacokinetics of Topically Applied IDP-123 Lotion in Comparison With Tazorac Cream in Subjects With Moderate to Severe Acne Vulgaris Under Maximal Use Conditions

Conditions
-----------------
Acne

Intervention / Treatment
-----------------
* Drug: IDP-123 Lotion
* Drug: Tazorac Cream


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Male or female, at least 9 years of age (at least 12 years of age for Tazorac Cream). Verbal and written informed consent must be obtained. Subjects less than age of consent must sign an assent for the study and a parent or a legal guardian must sign the informed consent (if the subject reaches age of consent during the study they should be re-consented at the next study visit). Subject must have a score of 3 (moderate) or 4 (severe) on the Evaluator's Global Severity assessment at the screening and baseline visit. Subjects with facial acne inflammatory lesion count no less than 20 but no more than 40. Subjects with facial acne non-inflammatory lesions count no less than 20 but no more than 100. Key Exclusion Criteria: Use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study. Any dermatological conditions on the face that could interfere with clinical evaluations such as acne conglobate, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, gram-negative folliculitis, dermatitis, eczema. Any underlying disease or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive. Subjects with a facial beard or mustache that could interfere with the study assessments. Subjects with more than 2 facial nodules.

Ages Eligible for Study
-----------------
Minimum Age: 9 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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-123 Lotion<br>Lotion | Drug: IDP-123 Lotion<br>* Lotion<br>* Other names: IDP-123;|
| Active Comparator: Tazorac Cream<br>Cream | Drug: Tazorac Cream<br>* Cream<br>* Other names: Tazorac;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluator's Global Severity Score: At Day 15 (or ET), acne severity will be determined by the investigator/evaluator based on a global assessment of the inflammatory and non-inflammatory lesions of facial acne. | Evaluations will be graded on a static scale ranging from 0 (clear) to 4 (severe) | 15 Days |