A Study to Compare FCD105 Foam to Minocycline 3% Foam, Adapalene 0.3% Foam and Vehicle Foam.

Study Overview
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Brief Summary
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A study comparing FCD105 to 3% minocycline foam, 0.3% adapalene foam and vehicle foam in patients ≥ 12 years old for the treatment of moderate-to-severe acne.

Official Title
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A Prospective, Multicenter, Randomized, Double-Blind, Vehicle-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of a Combination of 3% Minocycline and 0.3% Adapalene Topical Foam Formulation for the Treatment of Moderate-to-Severe Acne (Study FX2016 40)

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Combination Product: FCD105
* Drug: 3% Minocycline Foam
* Drug: 0.3% Adapalene Foam
* Other: Vehicle Foam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has facial acne vulgaris with all of the following: 20 to 50 inflammatory lesions (papules and/or pustules) on the face. 25 to 100 non-inflammatory lesions (open and closed comedones) on the face. IGA score of moderate (3) to severe (4). No more than two active nodules on the face. Willing to use only the supplied non-medicated cleanser and to refrain from use of any other acne medication, medicated cleanser, excessive sun exposure, and tanning booths for the duration of the study Exclusion Criteria: Female who is pregnant or lactating, or is planning a pregnancy during the study. Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne), or any dermatological condition of the face that could interfere with the clinical evaluations. Facial hair (eg, beard, mustache, etc.) that could interfere with the clinical evaluations. Sunburn on the face. Severe systemic disease as assessed by the Investigator that might interfere with the conduct of the study or the interpretation of the results. Subjects who have a documented history of any of the following: Allergy to tetracycline-class antibiotics or to any ingredient in the study drug. Pseudomembranous colitis or antibiotic-associated colitis. Hepatitis or clinically significant liver damage or clinically significant renal impairment. Known or suspected premalignant or malignant disease (excluding successfully treated skin cancers). Subjects who have used the following medications: Within 1 week prior to randomization: Medicated facial cleansers on the face. Topical acne treatments on the face (other than those listed below). Within 4 weeks prior to randomization: Topical retinoids on the face. Topical anti-inflammatories and/or corticosteroids on the face. Topical corticosteroids on body areas other than the face for more than 15 consecutive days and on more than 10% of the body surface area. In body folds, such as axillary and inguinal regions, only mild topical steroids are allowed for short term use (≤15 consecutive days). Systemic antibiotics. Systemic acne treatments. Within 12 weeks prior to randomization: Systemic retinoids. Systemic corticosteroids (Note: Intranasal and inhaled corticosteroids may be used throughout the study if the subject is on a stable dose). Use of sauna during the 2 weeks prior to randomization. Epilation of the face within 2 weeks prior to randomization. Folliculitis on the face. Documented history of depression that is not, in the opinion of the Investigator, currently adequately controlled with medication

Ages Eligible for Study
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Minimum Age: 12 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FCD105 Foam<br>FCD105 Foam | Combination Product: FCD105<br>* Experimental combination<br>|
| Active Comparator: 3% Minocycline Foam<br>3% Minocycline Foam | Drug: 3% Minocycline Foam<br>* Active Comparator<br>|
| Active Comparator: 0.3% Adapalene Foam<br>0.3% Adapalene Foam | Drug: 0.3% Adapalene Foam<br>* Active Comparator<br>|
| Placebo Comparator: Vehicle Foam<br>Vehicle Foam | Other: Vehicle Foam<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change from Baseline in inflammatory lesion counts at week 12 | Statistical superiority of FCD105 vs. vehicle in the absolute change from Baseline in inflammatory lesion counts at Visit 4 (Week12/End of Treatment) | 12 weeks | 
| Absolute change from Baseline in non-inflammatory lesion counts at week 12 | Statistical superiority of FCD105 vs. vehicle in the absolute change from Baseline in non-inflammatory lesion counts at Visit 4 (Week12/End of Treatment) | 12 weeks | 
| Investigator's Global Assessment (IGA) Treatment Success at Week 12 | Statistical superiority of FCD105 vs. vehicle in in IGA Treatment Success at Visit 4 (Week 12/End of Treatment), where success is defined as an IGA score of 0 or 1, and at least a 2-grade improvement (decrease) from Baseline. | 12 weeks |