Back to resultsA Study to Evaluate the Long-Term Safety of Topical Administration of FMX103 in the Treatment of Moderate to Severe Papulopustular Rosacea
Primary Purpose
Papulopustular Rosacea
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
FMX103 1.5%
Sponsored by
About this trial
This is an interventional treatment trial for Papulopustular Rosacea
Eligibility Criteria
Inclusion Criteria:
- Have completed 12 weeks of treatment in either Study FX2016-11 or Study FX2016-12.
- 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:
- 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.
- 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.
Sites / Locations
- Foamix Investigational Site # 207
- Foamix Investigational Site # 202
- Foamix Investigational Site # 222
- Foamix Investigational Site # 127
- Foamix Investigational Site # 226
- Foamix Investigational Site # 220
- Foamix Investigational Site # 131
- Foamix Investigational Site # 134
- Foamix Investigational Site # 114
- Foamix Investigational Site # 116
- Foamix Investigational Site # 135
- Foamix Investigational Site # 123
- Foamix Investigational Site # 239
- Foamix Investigational Site # 227
- Foamix Investigational Site # 223
- Foamix Investigational Site # 215
- Foamix Investigational Site # 109
- Foamix Investigational Site # 240
- Foamix Investigational Site # 112
- Foamix Investigational Site # 214
- Foamix Investigational Site # 241
- Foamix Investigational Site # 104
- Foamix Investigational Site # 121
- Foamix Investigational Site # 125
- Foamix Investigational Site # 124
- Foamix Investigational Site # 118
- Foamix Investigational Site # 204
- Foamix Investigational Site # 233
- Foamix Investigational Site # 139
- Foamix Investigational Site # 211
- Foamix Investigational Site # 138
- Foamix Investigational Site # 225
- Foamix Investigational Site # 218
- Foamix Investigational Site # 235
- Foamix Investigational Site # 237
- Foamix Investigational Site # 102
- Foamix Investigational Site # 115
- Foamix Investigational Site # 110
- Foamix Investigational Site # 107
- Foamix Investigational Site # 229
- Foamix Investigational Site # 137
- Foamix Investigational Site # 242
- Foamix Investigational Site # 210
- Foamix Investigational Site # 103
- Foamix Investigational Site # 120
- Foamix Investigational Site # 140
- Foamix Investigational Site # 232
- Foamix Investigational Site # 130
- Foamix Investigational Site # 133
- Foamix Investigational Site # 221
- Foamix Investigational Site # 136
- Foamix Investigational Site # 111
- Foamix Investigational Site # 119
- Foamix Investigational Site # 238
- Foamix Investigational Site # 212
- Foamix Investigational Site # 234
- Foamix Investigational Site # 101
- Foamix Investigational Site # 128
- Foamix Investigational Site # 236
- Foamix Investigational Site # 224
- Foamix Investigational Site # 141
- Foamix Investigational Site # 129
- Foamix Investigational Site # 105
- Foamix Investigational Site # 231
- Foamix Investigational Site # 106
- Foamix Investigational Site # 230
- Foamix Investigational Site # 228
- Foamix Investigational Site # 219
- Foamix Investigational Site # 132
- Foamix Investigational Site # 117
- Foamix Investigational Site # 201
- Foamix Investigational Site # 206
- Foamix Investigational Site # 108
- Foamix Investigational Site # 208
- Foamix Investigational Site # 213
- Foamix Investigational Site # 209
- Foamix Investigational Site # 126
- Foamix Investigational Site # 216
- Foamix Investigational Site # 203
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Minocycline Foam 1.5%
Arm Description
FMX-103
Outcomes
Primary Outcome Measures
Absolute Change From Baseline in Inflammatory Lesion Count at Week 40
Change from Baseline (Baseline visit in the initial DB study [FX2016-11 or FX2016-12] and Baseline visit of the open-label extension study [Week 12]) in inflammatory lesion count at Week 40 is reported. The lesion counts performed at Week 12 [Final Visit] in Study FX2016-11 or Study FX2016-12 constituted as the Baseline value for this study. Changes from Baseline were calculated as the Baseline [pre-dose] value minus the post-Baseline value, so that decreases reflected a reduction in lesion count. The number of papules, pustules, and nodules were counted, and the numbers recorded.
Percentage of Participants Achieving Investigator's Global Assessments (IGA) Treatment Success at Week 40
The IGA scale for Rosacea, was used by the Investigators to assess the severity of a participant's Rosacea. The scale ranges from 0 (Clear): No inflammatory papules or pustules to 4 (Severe): Many inflammatory papules or pustules, and up to 2 nodules. Higher scores indicated severe outcome. Treatment success was defined as an IGA score of 0 (score of clear) or 1 (almost clear), and at least a 2-grade improvement (decrease) from Baseline.
Secondary Outcome Measures
Absolute Change From Baseline in Inflammatory Lesion Count at Weeks 4, 10, 16, 22, 28, and 34
Change from Baseline (Baseline visit in the initial DB study [FX2016-11 or FX2016-12] and Baseline visit of the open-label extension study [Week 12]) in inflammatory lesion count at Week 40 is reported. The lesion counts performed at Week 12 [Final Visit] in Study FX2016-11 or Study FX2016-12 constituted as the Baseline value for this study. Changes from Baseline were calculated as the Baseline [pre-dose] value minus the post-Baseline value, so that decreases reflected a reduction in lesion count. The number of papules, pustules, and nodules were counted, and the numbers recorded.
Percentage of Participants Achieving IGA Treatment Success at Weeks 4, 10, 16, 22, 28 and 34
The IGA scale for Rosacea, was used by the Investigators to assess the severity of a participant's Rosacea. The scale ranges from 0 (Clear): No inflammatory papules or pustules to 4 (Severe): Many inflammatory papules or pustules, and up to 2 nodules. Higher scores indicated severe outcome. Treatment success was defined as an IGA score of 0 (score of clear) or 1 (almost clear), and at least a 2-grade improvement (decrease) from Baseline.
Percentage Change From Baseline in Inflammatory Lesion Count at Weeks 4, 10, 16, 22, 28, and 34
Change from Baseline (Baseline visit in the initial DB study [FX2016-11 or FX2016-12] and Baseline visit of the open-label extension study [Week 12]) in inflammatory lesion count at Week 40 is reported. The lesion counts performed at Week 12 [Final Visit] in Study FX2016-11 or Study FX2016-12 constituted as the Baseline value for this study. Changes from Baseline were calculated as the Baseline [pre-dose] value minus the post-Baseline value, so that decreases reflected a reduction in lesion count. The number of papules, pustules, and nodules were counted, and the numbers recorded.
Number of Participants Reporting Satisfaction and Dissatisfaction With the Study Drug Based on Subject Satisfaction Questionnaire (SSQ) at Week 40
The questionnaire consisted of questions with responses on scale with scores: as 1 (Very satisfied or Very likely ) to 5 (Very dissatisfied or Very unlikely) for each variable as for example, Easy to use, 1 is very satisfied and 5 is very dissatisfied. The minimum score represented best outcome and higher score represented worst outcome.
Number of Participants With Adverse Events (AEs)
Evaluation of the long-term safety of topical FMX103 1.5% minocycline foam in the treatment of moderate to severe facial papulopustular rosacea for 40 weeks. A Treatment-emergent Adverse Events (TEAEs) was defined as any AE with an onset date after the first dose date of the open-label extension study and before the last application of study drug plus 3 days having been absent pre-treatment or worsened relative to the pre-treatment state.
Full Information
NCT ID
NCT03276936
First Posted
August 21, 2017
Last Updated
January 13, 2022
Sponsor
Vyne Therapeutics Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03276936
Brief Title
A Study to Evaluate the Long-Term Safety of Topical Administration of FMX103 in the Treatment of Moderate to Severe Papulopustular Rosacea
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
September 5, 2017 (Actual)
Primary Completion Date
January 3, 2019 (Actual)
Study Completion Date
January 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vyne Therapeutics Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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 - NCT03142451). 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Papulopustular Rosacea
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
504 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Minocycline Foam 1.5%
Arm Type
Experimental
Arm Description
FMX-103
Intervention Type
Drug
Intervention Name(s)
FMX103 1.5%
Intervention Description
FMX103 1.5% minocycline foam
Primary Outcome Measure Information:
Title
Absolute Change From Baseline in Inflammatory Lesion Count at Week 40
Description
Change from Baseline (Baseline visit in the initial DB study [FX2016-11 or FX2016-12] and Baseline visit of the open-label extension study [Week 12]) in inflammatory lesion count at Week 40 is reported. The lesion counts performed at Week 12 [Final Visit] in Study FX2016-11 or Study FX2016-12 constituted as the Baseline value for this study. Changes from Baseline were calculated as the Baseline [pre-dose] value minus the post-Baseline value, so that decreases reflected a reduction in lesion count. The number of papules, pustules, and nodules were counted, and the numbers recorded.
Time Frame
Day 0/ Baseline (Final visit of previous DB study [Week 12]) and at Week 40
Title
Percentage of Participants Achieving Investigator's Global Assessments (IGA) Treatment Success at Week 40
Description
The IGA scale for Rosacea, was used by the Investigators to assess the severity of a participant's Rosacea. The scale ranges from 0 (Clear): No inflammatory papules or pustules to 4 (Severe): Many inflammatory papules or pustules, and up to 2 nodules. Higher scores indicated severe outcome. Treatment success was defined as an IGA score of 0 (score of clear) or 1 (almost clear), and at least a 2-grade improvement (decrease) from Baseline.
Time Frame
At Week 40
Secondary Outcome Measure Information:
Title
Absolute Change From Baseline in Inflammatory Lesion Count at Weeks 4, 10, 16, 22, 28, and 34
Description
Change from Baseline (Baseline visit in the initial DB study [FX2016-11 or FX2016-12] and Baseline visit of the open-label extension study [Week 12]) in inflammatory lesion count at Week 40 is reported. The lesion counts performed at Week 12 [Final Visit] in Study FX2016-11 or Study FX2016-12 constituted as the Baseline value for this study. Changes from Baseline were calculated as the Baseline [pre-dose] value minus the post-Baseline value, so that decreases reflected a reduction in lesion count. The number of papules, pustules, and nodules were counted, and the numbers recorded.
Time Frame
Day 0/ Baseline (Final visit of previous DB study [Week 12]) and at Weeks 4, 10, 16, 22, 28, and 34
Title
Percentage of Participants Achieving IGA Treatment Success at Weeks 4, 10, 16, 22, 28 and 34
Description
The IGA scale for Rosacea, was used by the Investigators to assess the severity of a participant's Rosacea. The scale ranges from 0 (Clear): No inflammatory papules or pustules to 4 (Severe): Many inflammatory papules or pustules, and up to 2 nodules. Higher scores indicated severe outcome. Treatment success was defined as an IGA score of 0 (score of clear) or 1 (almost clear), and at least a 2-grade improvement (decrease) from Baseline.
Time Frame
At Weeks 4, 10, 16, 22, 28 and Week 34
Title
Percentage Change From Baseline in Inflammatory Lesion Count at Weeks 4, 10, 16, 22, 28, and 34
Description
Change from Baseline (Baseline visit in the initial DB study [FX2016-11 or FX2016-12] and Baseline visit of the open-label extension study [Week 12]) in inflammatory lesion count at Week 40 is reported. The lesion counts performed at Week 12 [Final Visit] in Study FX2016-11 or Study FX2016-12 constituted as the Baseline value for this study. Changes from Baseline were calculated as the Baseline [pre-dose] value minus the post-Baseline value, so that decreases reflected a reduction in lesion count. The number of papules, pustules, and nodules were counted, and the numbers recorded.
Time Frame
Day 0/ Baseline (Final visit of previous DB study [Week 12]) and at Weeks 4, 10, 16, 22, 28, and 34
Title
Number of Participants Reporting Satisfaction and Dissatisfaction With the Study Drug Based on Subject Satisfaction Questionnaire (SSQ) at Week 40
Description
The questionnaire consisted of questions with responses on scale with scores: as 1 (Very satisfied or Very likely ) to 5 (Very dissatisfied or Very unlikely) for each variable as for example, Easy to use, 1 is very satisfied and 5 is very dissatisfied. The minimum score represented best outcome and higher score represented worst outcome.
Time Frame
At Week 40
Title
Number of Participants With Adverse Events (AEs)
Description
Evaluation of the long-term safety of topical FMX103 1.5% minocycline foam in the treatment of moderate to severe facial papulopustular rosacea for 40 weeks. A Treatment-emergent Adverse Events (TEAEs) was defined as any AE with an onset date after the first dose date of the open-label extension study and before the last application of study drug plus 3 days having been absent pre-treatment or worsened relative to the pre-treatment state.
Time Frame
Day 0/ Baseline (Final visit of previous DB study [Week 12]) until safety follow-up (Week 44)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have completed 12 weeks of treatment in either Study FX2016-11 or Study FX2016-12.
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:
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.
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.
Facility Information:
Facility Name
Foamix Investigational Site # 207
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85308
Country
United States
Facility Name
Foamix Investigational Site # 202
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Foamix Investigational Site # 222
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Facility Name
Foamix Investigational Site # 127
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Foamix Investigational Site # 226
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Foamix Investigational Site # 220
City
Murrieta
State/Province
California
ZIP/Postal Code
92562
Country
United States
Facility Name
Foamix Investigational Site # 131
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Foamix Investigational Site # 134
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
Foamix Investigational Site # 114
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Foamix Investigational Site # 116
City
San Luis Obispo
State/Province
California
ZIP/Postal Code
93405
Country
United States
Facility Name
Foamix Investigational Site # 135
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Foamix Investigational Site # 123
City
Santa Monica
State/Province
California
ZIP/Postal Code
90403
Country
United States
Facility Name
Foamix Investigational Site # 239
City
Temecula
State/Province
California
ZIP/Postal Code
92592
Country
United States
Facility Name
Foamix Investigational Site # 227
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Facility Name
Foamix Investigational Site # 223
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Foamix Investigational Site # 215
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33437
Country
United States
Facility Name
Foamix Investigational Site # 109
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33757
Country
United States
Facility Name
Foamix Investigational Site # 240
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Foamix Investigational Site # 112
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Foamix Investigational Site # 214
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Foamix Investigational Site # 241
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162
Country
United States
Facility Name
Foamix Investigational Site # 104
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Foamix Investigational Site # 121
City
Sanford
State/Province
Florida
ZIP/Postal Code
32771
Country
United States
Facility Name
Foamix Investigational Site # 125
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Foamix Investigational Site # 124
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Foamix Investigational Site # 118
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30022
Country
United States
Facility Name
Foamix Investigational Site # 204
City
Newnan
State/Province
Georgia
ZIP/Postal Code
78660
Country
United States
Facility Name
Foamix Investigational Site # 233
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Foamix Investigational Site # 139
City
Snellville
State/Province
Georgia
ZIP/Postal Code
30078
Country
United States
Facility Name
Foamix Investigational Site # 211
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60005
Country
United States
Facility Name
Foamix Investigational Site # 138
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
Foamix Investigational Site # 225
City
Newburgh
State/Province
Indiana
ZIP/Postal Code
47630
Country
United States
Facility Name
Foamix Investigational Site # 218
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States
Facility Name
Foamix Investigational Site # 235
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Facility Name
Foamix Investigational Site # 237
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Facility Name
Foamix Investigational Site # 102
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Foamix Investigational Site # 115
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Foamix Investigational Site # 110
City
Beverly
State/Province
Massachusetts
ZIP/Postal Code
01915
Country
United States
Facility Name
Foamix Investigational Site # 107
City
Brighton
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
Foamix Investigational Site # 229
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
Facility Name
Foamix Investigational Site # 137
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48103
Country
United States
Facility Name
Foamix Investigational Site # 242
City
Bay City
State/Province
Michigan
ZIP/Postal Code
48706
Country
United States
Facility Name
Foamix Investigational Site # 210
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Foamix Investigational Site # 103
City
Fort Gratiot
State/Province
Michigan
ZIP/Postal Code
48059
Country
United States
Facility Name
Foamix Investigational Site # 120
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Facility Name
Foamix Investigational Site # 140
City
Warren
State/Province
Michigan
ZIP/Postal Code
48088
Country
United States
Facility Name
Foamix Investigational Site # 232
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Foamix Investigational Site # 130
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64506
Country
United States
Facility Name
Foamix Investigational Site # 133
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
Foamix Investigational Site # 221
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Foamix Investigational Site # 136
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
Foamix Investigational Site # 111
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11790
Country
United States
Facility Name
Foamix Investigational Site # 119
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Facility Name
Foamix Investigational Site # 238
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Foamix Investigational Site # 212
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Foamix Investigational Site # 234
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Foamix Investigational Site # 101
City
Bexley
State/Province
Ohio
ZIP/Postal Code
43209
Country
United States
Facility Name
Foamix Investigational Site # 128
City
Dublin
State/Province
Ohio
ZIP/Postal Code
43016
Country
United States
Facility Name
Foamix Investigational Site # 236
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73071
Country
United States
Facility Name
Foamix Investigational Site # 224
City
Exton
State/Province
Pennsylvania
ZIP/Postal Code
19341
Country
United States
Facility Name
Foamix Investigational Site # 141
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Facility Name
Foamix Investigational Site # 129
City
Yardley
State/Province
Pennsylvania
ZIP/Postal Code
19067
Country
United States
Facility Name
Foamix Investigational Site # 105
City
Johnston
State/Province
Rhode Island
ZIP/Postal Code
02919
Country
United States
Facility Name
Foamix Investigational Site # 231
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
Foamix Investigational Site # 106
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
Foamix Investigational Site # 230
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Foamix Investigational Site # 228
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37922
Country
United States
Facility Name
Foamix Investigational Site # 219
City
Arlington
State/Province
Texas
ZIP/Postal Code
76011
Country
United States
Facility Name
Foamix Investigational Site # 132
City
Austin
State/Province
Texas
ZIP/Postal Code
78746
Country
United States
Facility Name
Foamix Investigational Site # 117
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
Foamix Investigational Site # 201
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Foamix Investigational Site # 206
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Facility Name
Foamix Investigational Site # 108
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Facility Name
Foamix Investigational Site # 208
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Foamix Investigational Site # 213
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Foamix Investigational Site # 209
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
Foamix Investigational Site # 126
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84117
Country
United States
Facility Name
Foamix Investigational Site # 216
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States
Facility Name
Foamix Investigational Site # 203
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Evaluate the Long-Term Safety of Topical Administration of FMX103 in the Treatment of Moderate to Severe Papulopustular Rosacea
We'll reach out to this number within 24 hrs