A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study in the Treatment of Acne Vulgaris

Study Overview
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Brief Summary
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A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study in the Treatment of Acne Vulgaris

Detailed Description
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A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study Comparing the Efficacy and Safety of IDP-126 Gel in the Treatment of Acne Vulgaris

Official Title
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A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study Comparing the Efficacy and Safety of IDP-126 Gel in the Treatment of Acne Vulgaris

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: IDP-126 Gel
* Drug: IDP-126 Component A
* Drug: IDP-126 Component B
* Drug: IDP-126 Component C
* Drug: IDP-126 Vehicle Gel


Participation Criteria
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Eligibility Criteria
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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). Subject must have an EGSS of 3 (moderate) or 4 (severe) at the baseline visit. Subjects with a facial acne inflammatory lesion (papules, pustules, and nodules) count no less than 20, but no more than 100. Subjects with a facial acne non-inflammatory lesion (open and closed comedones) count no less than 30, but no more than 150. Subjects with 2 or fewer facial nodules 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, gram negative folliculitis, dermatitis, eczema. 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. Subjects with more than 2 facial nodules. Evidence or history of cosmetic-related acne.

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 99 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
Interventional Model Description: Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IDP-126 Gel<br>Gel | Drug: IDP-126 Gel<br>* Gel<br>|
| Active Comparator: IDP-126 Component A<br>Component A | Drug: IDP-126 Component A<br>* Component A<br>|
| Active Comparator: IDP-126 Component B<br>Component B | Drug: IDP-126 Component B<br>* Component B<br>|
| Active Comparator: IDP-126 Component C<br>Component C | Drug: IDP-126 Component C<br>* Component C<br>|
| Placebo Comparator: IDP-126 Vehicle Gel<br>Vehicle Gel | Drug: IDP-126 Vehicle Gel<br>* Vehicle Gel<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory Lesion Counts | Absolute change from Baseline to Week 12 in mean inflammatory lesion counts | Baseline to Week 12 | 
| Non-inflammatory Lesion Counts | Absolute change from Baseline to Week 12 in mean non-inflammatory lesion counts | Baseline to Week 12 | 
| Percentage of Participants With Success on the Evaluator's Global Severity Score | Success was defined as at least a two grade reduction and clear or almost clear at Week 12. The Evaluator's Global Severity Score has grades for acne severity of 0 (Clear), 1 (Almost Clear), 2 (Mild), 3 (Moderate), and 4 (Severe), with higher scores indicating worse severity. | Baseline to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory Lesion Count Changes at Week 2, 4, and 8 | Absolute change from Baseline to Week 2, 4, and 8 in mean inflammatory lesion counts | Baseline to Week 2, 4, 8 | 
| Non-inflammatory Lesion Count Changes at Week 2, 4, and 8 | Absolute change from Baseline to Week 2, 4, and 8 in mean non-inflammatory lesion counts | Baseline to Week 2, 4, 8 | 
| Inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8 | Percentage change from Baseline to Week 2, 4, and 8 in mean inflammatory lesion counts | Baseline to Week 2, 4, 8 | 
| Non-inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8 | Percentage change from Baseline to Week 2, 4, and 8 in mean non-inflammatory lesion counts | Baseline to Week 2, 4, 8 | 
| Percentage of Participants With Success on the Evaluator's Global Severity Score at Weeks 2, 4, and 8 | Success was defined as at least a two grade reduction and clear or almost clear at the visit. The Evaluator's Global Severity Score has grades for acne severity of 0 (Clear), 1 (Almost Clear), 2 (Mild), 3 (Moderate), and 4 (Severe), with higher scores indicating worse severity. | Baseline to Week 2, 4, and 8 | 
| Percentage of Participants With Two Grade Success on the Evaluator's Global Severity Score - at Weeks 2, 4, and 8 | Two grade success was defined as at least a two grade reduction. The Evaluator's Global Severity Score has grades for acne severity of 0 (Clear), 1 (Almost Clear), 2 (Mild), 3 (Moderate), and 4 (Severe), with higher scores indicating worse severity. | Baseline to Week 2, 4, and 8 |