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
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Alpharetta, Georgia 30022
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Ann Arbor, Michigan 48103
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Boca Raton, Florida 33486
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Charleston, South Carolina 29407
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Charlotte, North Carolina 28277
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Detroit, Michigan 48202
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