A Study to Evaluate the Long-Term Safety of Topical Administration of FMX103 in the Treatment of Moderate to Severe Papulopustular Rosacea



Status:Active, not recruiting
Conditions:Cosmetic
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:6/29/2018
Start Date:September 1, 2017
End Date:March 29, 2019

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An Open-Label Study to Evaluate the Long-Term Safety of Topical Administration of FMX103 for 40 Weeks in the Treatment of Moderate to Severe Facial Papulopustular Rosacea (Study FX2016-13)

The primary objective is to show that open-label extended treatment with FMX103 1.5%, for up
to an additional 40 weeks, is safe and well tolerated.

This is an open-label, multicenter, 40-week extension study to evaluate the long-term safety,
tolerability, and efficacy of FMX103 1.5% topical foam in the treatment of moderate-to-severe
facial papulopustular rosacea. Subjects entering this study will have recently participated
in 1 of 2 pivotal, double-blind, vehicle-controlled, safety and efficacy studies (FX2016-11
and FX2016-12). Subjects must demonstrate that they are eligible to continue into Study
FX2016-13 based on safety evaluations and IGA score performed at Final Visit of one of the
previous double-blind studies.

At the completion of the Final Visit in Study FX2016-11 or Study FX2016-12, subjects may be
invited to continue into this open-label study for an additional 40 weeks of open-label
treatment. A minimum of 400 subjects will be enrolled into from Studies FX2016-11 and
FX2016-12. Subjects who elect to continue into this open-label study will receive supplies of
active FMX103 1.5% minocycline foam.

Inclusion Criteria:

1. Have completed 12 weeks of treatment in either Study FX2016-11 or Study FX2016-12.

2. Have not had a worsening of disease, determined by the Investigator's Global
Assessment (IGA), at Visit 5/Week 12 (Final Visit) relative to the Day 0/Baseline
assessment in Study FX2016-11 or Study FX2016-12.

Exclusion Criteria:

1. Have a new systemic disease or condition, including an ongoing AE that might interfere
with the conduct of the study or the interpretation of results.

2. Have developed a condition that would have been exclusionary for Study FX2016-11 or
Study FX2016-12, including pseudomembranous colitis, antibiotic associated colitis,
hepatitis, liver damage, renal impairment, drug addiction, or alcohol abuse.
We found this trial at
75
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Charlotte, North Carolina 28277
2101
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Charlotte, NC
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Alpharetta, Georgia 30022
1920
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Alpharetta, GA
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Ann Arbor, Michigan 48103
1931
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Arlington, Texas 76011
1207
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Arlington, TX
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Arlington Heights, Illinois 60005
1610
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Austin, Texas 78746
1212
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Austin, TX
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Bay City, Michigan 48706
1934
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Beverly, Massachusetts 01915
2586
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Beverly, MA
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1964
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Bexley, OH
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Boca Raton, Florida 33486
2312
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Boynton Beach, Florida 33437
2309
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Brighton, Massachusetts 02135
2573
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Charleston, South Carolina 29407
2185
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Clearwater, Florida 33757
2116
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Clearwater, FL
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Denver, Colorado 80209
818
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Denver, CO
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Detroit, Michigan 48202
1966
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Detroit, MI
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1954
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Dublin, OH
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Exton, Pennsylvania 19341
2350
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Exton, PA
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Fort Gratiot, Michigan 48059
?
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Fort Gratiot, MI
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Fort Myers, Florida 33912
2205
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Fremont, California 94538
327
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Fremont, CA
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Fridley, Minnesota 55432
1512
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Glendale, Arizona 85308
336
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Glendale, AZ
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Greenville, South Carolina 29607
2019
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Hialeah, Florida 33016
2314
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High Point, North Carolina 27262
1997
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High Point, NC
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Hot Springs, Arkansas 71913
1421
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Houston, Texas 77004
1358
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Jenkintown, Pennsylvania 19046
2376
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Johnston, Rhode Island 02919
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Knoxville, Tennessee 37922
1923
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Las Vegas, Nevada 89128
217
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Los Angeles, California 90045
13
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Louisville, Kentucky 40217
1812
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Lynchburg, Virginia 24501
2176
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Metairie, Louisiana 70006
1650
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Miami, Florida 33126
2322
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Mount Pleasant, South Carolina 29464
2188
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Murrieta, California 92562
58
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New Albany, Indiana 47150
1809
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New Orleans, Louisiana 70115
1655
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New York, New York 10075
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Newburgh, Indiana 47630
1723
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Newnan, Georgia 78660
1900
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Norman, Oklahoma 73071
1170
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North Miami Beach, Florida 33162
2319
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Oceanside, California 92056
70
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Omaha, Nebraska 68144
1301
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Ormond Beach, Florida 32174
2186
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Pflugerville, Texas 78660
1215
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Raleigh, North Carolina 27612
2218
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Rogers, Arkansas 72758
1354
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Sacramento, California 95819
366
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Saint Joseph, Missouri 64506
1334
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Salt Lake City, Utah 84117
570
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San Antonio, Texas 78213
1188
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San Diego, California 92123
106
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San Luis Obispo, California 93405
171
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Sandy Springs, Georgia 30328
1917
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Sanford, Florida 32771
2184
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Santa Ana, California 92705
25
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Santa Monica, California 90403
27
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Seattle, Washington 98104
961
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Snellville, Georgia 30078
1938
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South Bend, Indiana 46617
1798
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Stony Brook, New York 11790
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Tampa, Florida 33609
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Temecula, California 92592
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Troy, Michigan 48084
1831
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Warren, Michigan 48088
1968
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Watertown, Massachusetts 02472
2571
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Webster, Texas 77598
1377
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West Palm Beach, Florida 33409
2304
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Winston-Salem, North Carolina 27103
2126
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Yardley, Pennsylvania 19067
2390
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