A Study to Evaluate the Efficacy and Safety of Topical Administration of FMX101 in the Treatment of Moderate-to-Severe Acne Vulgaris

Phase 3

Completed

Brief Summary: A Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Efficacy and Safety of Topical Administration of FMX101 for 12 Weeks in the Treatment of Moderate-to-Severe Acne Vulgaris (Study FX2017-22)

Detailed Description: This is a randomized, multicenter, double-blind, vehicle-controlled, 2 arm study to evaluate the safety and efficacy over 12 weeks of FMX101 topical foam containing 4% minocycline compared to vehicle in the treatment of subjects with moderate-to-severe facial acne vulgaris. Qualified subjects will be randomized to receive 1 of the following 2 treatments:

* FMX101 4% minocycline foam

* Vehicle foam

Recruitment & Eligibility

Inclusion Criteria

Has facial acne vulgaris with:
1. 20 to 50 inflammatory lesions (papules, pustules, and nodules)
2. 25 to 100 non-inflammatory lesions (open and closed comedones)
3. No more than 2 nodules on the face
4. IGA score of moderate (3) to severe (4)
Willing to use only the supplied non-medicated cleanser (Cetaphil Gentle Skin 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

Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne), or any dermatological condition of the face or facial hair (eg, beard, sideburns, mustache) that could interfere with the clinical evaluations.
Sunburn on the face.

Arm && Interventions

Group	Intervention	Description
FMX101, 4% minocycline foam	FMX101	FMX101, 4% minocycline foam applied topically once daily for 12 weeks
Vehicle foam	Vehicle Foam	Vehicle foam applied topically once daily for 12 weeks

Primary Outcome Measures

Name	Time	Method
The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 12.	12 weeks	A decrease in the inflammatory lesion count from Baseline to Week 12.
Investigator Global Assessment (IGA) Treatment Success (Dichotomized as Yes/no) at Week 12, Where Success is Defined as an IGA Score of 0 or 1, and at Least a 2-grade Improvement (Decrease) From Baseline	12 weeks

Secondary Outcome Measures

Name	Time	Method
The Absolute Change From Baseline in the Non-inflammatory Lesion Count at Week 12	12 weeks
IGA Treatment Success (Dichotomized as Yes/no) at Week 9, Where Success is Defined as an IGA Score of 0 or 1, and at Least a 2-grade Improvement (Decrease) From Baseline at the Interim Visit at Week 9	9 weeks
The Absolute Change From Baseline in the Inflammatory Lesion Count at the Interim Visit at Week 6	6 weeks
The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 9	9 weeks
IGA Treatment Success (Dichotomized as Yes/no) at Week 6, Where Success is Defined as an IGA Score of 0 or 1, and at Least a 2-grade Improvement (Decrease) From Baseline at the Interim Visit at Week 6	6 weeks

Locations (97): Foamix Investigational Site #376
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Phoenix, Arizona, United States
Foamix Investigational Site #395
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Tucson, Arizona, United States
Foamix Investigational Site #315
🇺🇸
Bryant, Arkansas, United States
Foamix Investigational Site #340
🇺🇸
Fort Smith, Arkansas, United States
Foamix Investigational SIte #377
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Little Rock, Arkansas, United States
Foamix Investigational Site #366
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Encino, California, United States
Foamix Investigational Site #403
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Los Angeles, California, United States
Foamix Investigational Site #303
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Murrieta, California, United States
Foamix Investigational Site #369
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Northridge, California, United States
Foamix Investigational Site #387
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Palm Springs, California, United States
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Foamix Investigational Site #376
🇺🇸Phoenix, Arizona, United States