Efficacy and Safety of IDP-120 Gel in the Treatment of Acne Vulgaris

Study Overview
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Brief Summary
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Efficacy and Safety of IDP-120 Gel in the Treatment of Acne Vulgaris

Detailed Description
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A Phase 2, Multi-Center, Randomized, Double-Blind, Vehicle- Controlled, Parallel-Group, Clinical Study Comparing the Efficacy and Safety of IDP-120 Gel in the Treatment of Acne Vulgaris

Official Title
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A Phase 2, Multi-Center, Randomized, Double-Blind, Vehicle- Controlled, Parallel-Group, Clinical Study Comparing the Efficacy and Safety of IDP-120 Gel in the Treatment of Acne Vulgaris

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: IDP-120 Gel
* Drug: IDP 120 Component A Gel
* Drug: IDP 120 Component B Gel
* Drug: IDP 120 Vehicle Gel


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Male or female at least 9 years of age and older; Written and verbal 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 subject reaches age of consent during the study they should be re-consented at the next study visit) Pre-menses females and women of childbearing potential must have a negative urine pregnancy test at screening visit, and a negative urine pregnancy test at baseline visit. Subjects must be willing to comply with study instructions and return to the clinic for required visits. Subjects under the age of consent must be accompanied by the parent or legal guardian at the time of assent/consent signing. If a cleanser, moisturizer or sunscreen is needed during the study, Subjects must be willing to use only allowed cleansers, moisturizers, sunscreens, or moisturizer/sunscreen combination products. If the subject wears makeup they must agree to use non-comedogenic makeup. 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 conglobata, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, gramnegative folliculitis. Any underlying disease(s) 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.

Ages Eligible for Study
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Minimum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IDP-120 Gel<br>IDP-120 Gel is a combination treatment | Drug: IDP-120 Gel<br>* IDP-120 Gel is a combination product<br>* Other names: Component A + B;|
| Active Comparator: IDP-120 Component A Gel<br>IDP-120 Monad Gel of Component A | Drug: IDP 120 Component A Gel<br>* Monad of Component A<br>* Other names: Component A;|
| Active Comparator: IDP-120 Component B Gel<br>IDP-120 Monad Gel of Component B | Drug: IDP 120 Component B Gel<br>* Monad of Component B<br>* Other names: Component B;|
| Placebo Comparator: IDP-120 Vehicle Gel<br>IDP-120 Vehicle Gel | Drug: IDP 120 Vehicle Gel<br>* Vehicle<br>* Other names: Vehicle;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of subjects achieving clear or almost clear on the Evaluator's Global Severity Score. | Percent of subjects who achieve at least a two-grade reduction from Baseline and are Clear or Almost Clear at Week 12 in the Evaluator's Global Severity Score. | 12 Weeks |