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 |
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.
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.
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
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials