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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FCD105 Foam | Experimental | FCD105 Foam |
|
| 3% Minocycline Foam | Active Comparator | 3% Minocycline Foam |
|
| 0.3% Adapalene Foam | Active Comparator | 0.3% Adapalene Foam |
|
| Vehicle Foam | Placebo Comparator | Vehicle Foam |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FCD105 | Combination Product | Experimental combination |
| |
| 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 |
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Inclusion Criteria:
Has facial acne vulgaris with all of the following:
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:
Subjects who have used the following medications:
Within 1 week prior to randomization:
Within 4 weeks prior to randomization:
Within 12 weeks prior to randomization:
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foamix Institution #134 | Bryant | Arkansas | 72022 | United States | ||
| Foamix Institution #121 |
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| 3% Minocycline Foam |
| Drug |
Active Comparator |
|
| 0.3% Adapalene Foam | Drug | Active Comparator |
|
| Vehicle Foam | Other | Placebo |
|
| Rogers |
| Arkansas |
| 72758 |
| United States |
| Foamix Institution #106 | Encino | California | 91436 | United States |
| Foamix Institution #103 | Fremont | California | 94538 | United States |
| Foamix Institution #122 | Huntington Beach | California | 92647 | United States |
| Foamix Institution #109 | Manhattan Beach | California | 90266 | United States |
| Foamix Institution #132 | San Diego | California | 92123 | United States |
| Foamix Institution #107 | Hialeah | Florida | 33016 | United States |
| Foamix Institution #127 | Lake City | Florida | 32055 | United States |
| Foamix Institution #101 | Miami | Florida | 33126 | United States |
| Foamix Institution #135 | Miami Beach | Florida | 33162 | United States |
| Foamix Institution #118 | Sanford | Florida | 32771 | United States |
| Foamix Institution #120 | Sunrise | Florida | 33351 | United States |
| Foamix Institution #128 | Tampa | Florida | 33607 | United States |
| Foamix Institution #130 | New Albany | Indiana | 47150 | United States |
| Foamix Institution #116 | Plainfield | Indiana | 46168 | United States |
| Foamix Institution #123 | Louisville | Kentucky | 40241 | United States |
| Foamix Institution #126 | Baton Rouge | Louisiana | 70809 | United States |
| Foamix Institution #124 | New Orleans | Louisiana | 70115 | United States |
| Foamix Institution #136 | Watertown | Massachusetts | 02472 | United States |
| Foamix Institution #114 | Clinton Township | Michigan | 48038 | United States |
| Foamix Institution #111 | Fridley | Minnesota | 55432 | United States |
| Foamix Institution #102 | Las Vegas | Nevada | 89148 | United States |
| Foamix Institution #115 | New York | New York | 10022 | United States |
| Foamix Institution #108 | Stony Brook | New York | 11790 | United States |
| Foamix Institution #104 | High Point | North Carolina | 27262 | United States |
| Foamix Institution #133 | Gresham | Oregon | 97030 | United States |
| Foamix Institution #125 | Johnston | Rhode Island | 02919 | United States |
| Foamix Institution #119 | Mt. Pleasant | South Carolina | 29464 | United States |
| Foamix Institution #110 | Arlington | Texas | 76011 | United States |
| Foamix Institution #117 | College Station | Texas | 77845 | United States |
| Foamix Institution #112 | Pflugerville | Texas | 78660 | United States |
| Foamix Institution #105 | San Antonio | Texas | 78213 | United States |
| Foamix Institution #131 | Layton | Utah | 84041 | United States |
| Foamix Institution #113 | Spokane | Washington | 99202 | United States |
| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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