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
sites
High Point, North Carolina 27262
2183
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from 98109
High Point, NC
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Alpharetta, Georgia 30022
2169
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Alpharetta, GA
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Ann Arbor, Michigan 48103
1902
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Ann Arbor, MI
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Arlington, Texas 76011
1670
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Arlington, TX
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Arlington Heights, Illinois 60005
1706
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Arlington Heights, IL
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Austin, Texas 78746
1770
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Austin, TX
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Bay City, Michigan 48706
1859
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Bay City, MI
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Beverly, Massachusetts 01915
2487
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Beverly, MA
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2011
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Bexley, OH
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Boca Raton, Florida 33486
2708
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Boynton Beach, Florida 33437
2701
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Boynton Beach, FL
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Brighton, Massachusetts 02135
2481
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Brighton, MA
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Charleston, South Carolina 29407
2423
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Charleston, SC
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Charlotte, North Carolina 28277
2281
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Charlotte, NC
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Clearwater, Florida 33757
2511
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Clearwater, FL
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Denver, Colorado 80209
1020
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Denver, CO
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Detroit, Michigan 48202
1933
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Detroit, MI
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1998
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Dublin, OH
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Exton, Pennsylvania 19341
2349
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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
2618
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Fort Myers, FL
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Fremont, California 94538
697
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Fremont, CA
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Fridley, Minnesota 55432
1389
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Fridley, MN
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Glendale, Arizona 85308
1107
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Greenville, South Carolina 29607
2224
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Greenville, SC
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Hialeah, Florida 33016
2724
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Hialeah, FL
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Hot Springs, Arkansas 71913
1759
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Houston, Texas 77004
1890
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Houston, TX
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Jenkintown, Pennsylvania 19046
2370
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Johnston, Rhode Island 02919
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Knoxville, Tennessee 37922
2110
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Las Vegas, Nevada 89128
873
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Las Vegas, NV
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Los Angeles, California 90045
962
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Los Angeles, CA
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Louisville, Kentucky 40217
1939
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Lynchburg, Virginia 24501
2277
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Lynchburg, VA
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Metairie, Louisiana 70006
2094
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Metairie, LA
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Miami, Florida 33126
2731
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Miami, FL
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Mount Pleasant, South Carolina 29464
2426
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Murrieta, California 92562
1008
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New Albany, Indiana 47150
1935
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New Orleans, Louisiana 70115
2099
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New York, New York 10075
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Newburgh, Indiana 47630
1874
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Newnan, Georgia 78660
2176
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Norman, Oklahoma 73071
1538
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Norman, OK
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North Miami Beach, Florida 33162
2725
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Oceanside, California 92056
1030
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Omaha, Nebraska 68144
1367
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Omaha, NE
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Ormond Beach, Florida 32174
2527
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Pflugerville, Texas 78660
1766
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Raleigh, North Carolina 27612
2362
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Rogers, Arkansas 72758
1633
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Sacramento, California 95819
626
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Saint Joseph, Missouri 64506
1467
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Salt Lake City, Utah 84117
701
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San Antonio, Texas 78213
1787
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San Diego, California 92123
1065
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San Luis Obispo, California 93405
857
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Sandy Springs, Georgia 30328
2172
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Sanford, Florida 32771
2540
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Santa Ana, California 92705
987
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Santa Monica, California 90403
961
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Seattle, Washington 98104
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Snellville, Georgia 30078
2191
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South Bend, Indiana 46617
1803
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Stony Brook, New York 11790
2139
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Tampa, Florida 33609
2527
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Temecula, California 92592
1014
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Troy, Michigan 48084
1757
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Warren, Michigan 48088
1930
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Watertown, Massachusetts 02472
2479
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Webster, Texas 77598
1912
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West Palm Beach, Florida 33409
2692
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Winston-Salem, North Carolina 27103
2275
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Yardley, Pennsylvania 19067
2378
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Yardley, PA
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