Clinical trial NCT03276936: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Papulopustular Rosacea
Lead sponsor: Vyne Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2017-09-08
Enrollment: 504
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Absolute Change From Baseline in Inflammatory Lesion Count at Week 40
timeFrame: Day 0/ Baseline (Final visit of previous DB study [Week 12]) and at Week 40
measure: Percentage of Participants Achieving Investigator's Global Assessments (IGA) Treatment Success at Week 40
timeFrame: At Week 40
Secondary outcomes:
measure: Absolute Change From Baseline in Inflammatory Lesion Count at Weeks 4, 10, 16, 22, 28, and 34
timeFrame: Day 0/ Baseline (Final visit of previous DB study [Week 12]) and at Weeks 4, 10, 16, 22, 28, and 34
measure: Percentage of Participants Achieving IGA Treatment Success at Weeks 4, 10, 16, 22, 28 and 34
timeFrame: At Weeks 4, 10, 16, 22, 28 and Week 34
measure: Percentage Change From Baseline in Inflammatory Lesion Count at Weeks 4, 10, 16, 22, 28, and 34
timeFrame: Day 0/ Baseline (Final visit of previous DB study [Week 12]) and at Weeks 4, 10, 16, 22, 28, and 34
measure: Number of Participants Reporting Satisfaction and Dissatisfaction With the Study Drug Based on Subject Satisfaction Questionnaire (SSQ) at Week 40
timeFrame: At Week 40
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Day 0/ Baseline (Final visit of previous DB study [Week 12]) until safety follow-up (Week 44)
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Foamix Investigational Site # 207
state: Arizona
city: Hot Springs
country: United States
facility: Foamix Investigational Site # 202
state: Arkansas
city: Rogers
country: United States
facility: Foamix Investigational Site # 222
state: Arkansas
city: Fremont
country: United States
facility: Foamix Investigational Site # 127
state: California
city: Los Angeles
country: United States
facility: Foamix Investigational Site # 226
state: California
city: Murrieta
country: United States
facility: Foamix Investigational Site # 220
state: California
city: Oceanside
country: United States
facility: Foamix Investigational Site # 131
state: California
city: Sacramento
country: United States
facility: Foamix Investigational Site # 134
state: California
city: San Diego
country: United States
facility: Foamix Investigational Site # 114
state: California
city: San Luis Obispo
country: United States
facility: Foamix Investigational Site # 116
state: California
city: Santa Ana
country: United States
facility: Foamix Investigational Site # 135
state: California
city: Santa Monica
country: United States
facility: Foamix Investigational Site # 123
state: California
city: Temecula
country: United States
facility: Foamix Investigational Site # 239
state: California
city: Denver
country: United States
facility: Foamix Investigational Site # 227
state: Colorado
city: Boca Raton
country: United States
facility: Foamix Investigational Site # 223
state: Florida
city: Boynton Beach
country: United States
facility: Foamix Investigational Site # 215
state: Florida
city: Clearwater
country: United States
facility: Foamix Investigational Site # 109
state: Florida
city: Fort Myers
country: United States
facility: Foamix Investigational Site # 240
state: Florida
city: Hialeah
country: United States
facility: Foamix Investigational Site # 112
state: Florida
city: Miami
country: United States
facility: Foamix Investigational Site # 214
state: Florida
city: North Miami Beach
country: United States
facility: Foamix Investigational Site # 241
state: Florida
city: Ormond Beach
country: United States
facility: Foamix Investigational Site # 104
state: Florida
city: Sanford
country: United States
facility: Foamix Investigational Site # 121
state: Florida
city: Tampa
country: United States
facility: Foamix Investigational Site # 125
state: Florida
city: West Palm Beach
country: United States
facility: Foamix Investigational Site # 124
state: Florida
city: Alpharetta
country: United States
facility: Foamix Investigational Site # 118
state: Georgia
city: Newnan
country: United States
facility: Foamix Investigational Site # 204
state: Georgia
city: Sandy Springs
country: United States
facility: Foamix Investigational Site # 233
state: Georgia
city: Snellville
country: United States
facility: Foamix Investigational Site # 139
state: Georgia
city: Arlington Heights
country: United States
facility: Foamix Investigational Site # 211
state: Illinois
city: New Albany
country: United States
facility: Foamix Investigational Site # 138
state: Indiana
city: Newburgh
country: United States
facility: Foamix Investigational Site # 225
state: Indiana
city: South Bend
country: United States
facility: Foamix Investigational Site # 218
state: Indiana
city: Louisville
country: United States
facility: Foamix Investigational Site # 235
state: Kentucky
city: Louisville
country: United States
facility: Foamix Investigational Site # 237
state: Kentucky
city: Metairie
country: United States
facility: Foamix Investigational Site # 102
state: Louisiana
city: New Orleans
country: United States
facility: Foamix Investigational Site # 115
state: Louisiana
city: Beverly
country: United States
facility: Foamix Investigational Site # 110
state: Massachusetts
city: Brighton
country: United States
facility: Foamix Investigational Site # 107
state: Massachusetts
city: Watertown
country: United States
facility: Foamix Investigational Site # 229
state: Massachusetts
city: Ann Arbor
country: United States
facility: Foamix Investigational Site # 137
state: Michigan
city: Bay City
country: United States
facility: Foamix Investigational Site # 242
state: Michigan
city: Detroit
country: United States
facility: Foamix Investigational Site # 210
state: Michigan
city: Fort Gratiot
country: United States
facility: Foamix Investigational Site # 103
state: Michigan
city: Troy
country: United States
facility: Foamix Investigational Site # 120
state: Michigan
city: Warren
country: United States
facility: Foamix Investigational Site # 140
state: Michigan
city: Fridley
country: United States
facility: Foamix Investigational Site # 232
state: Minnesota
city: Saint Joseph
country: United States
facility: Foamix Investigational Site # 130
state: Missouri
city: Omaha
country: United States
facility: Foamix Investigational Site # 133
state: Nebraska
city: Las Vegas
country: United States
facility: Foamix Investigational Site # 221
state: Nevada
city: New York
country: United States
facility: Foamix Investigational Site # 136
state: New York
city: Stony Brook
country: United States
facility: Foamix Investigational Site # 111
state: New York
city: Charlotte
country: United States
facility: Foamix Investigational Site # 119
state: North Carolina
city: High Point
country: United States
facility: Foamix Investigational Site # 238
state: North Carolina
city: Raleigh
country: United States
facility: Foamix Investigational Site # 212
state: North Carolina
city: Winston-Salem
country: United States
facility: Foamix Investigational Site # 234
state: North Carolina
city: Bexley
country: United States
facility: Foamix Investigational Site # 101
state: Ohio
city: Dublin
country: United States
facility: Foamix Investigational Site # 128
state: Ohio
city: Norman
country: United States
facility: Foamix Investigational Site # 236
state: Oklahoma
city: Exton
country: United States
facility: Foamix Investigational Site # 224
state: Pennsylvania
city: Jenkintown
country: United States
facility: Foamix Investigational Site # 141
state: Pennsylvania
city: Yardley
country: United States
facility: Foamix Investigational Site # 129
state: Pennsylvania
city: Johnston
country: United States
facility: Foamix Investigational Site # 105
state: Rhode Island
city: Charleston
country: United States
facility: Foamix Investigational Site # 231
state: South Carolina
city: Greenville
country: United States
facility: Foamix Investigational Site # 106
state: South Carolina
city: Mount Pleasant
country: United States
facility: Foamix Investigational Site # 230
state: South Carolina
city: Knoxville
country: United States
facility: Foamix Investigational Site # 228
state: Tennessee
city: Arlington
country: United States
facility: Foamix Investigational Site # 219
state: Texas
city: Austin
country: United States
facility: Foamix Investigational Site # 132
state: Texas
city: Austin
country: United States
facility: Foamix Investigational Site # 117
state: Texas
city: Houston
country: United States
facility: Foamix Investigational Site # 201
state: Texas
city: Pflugerville
country: United States
facility: Foamix Investigational Site # 206
state: Texas
city: San Antonio
country: United States
facility: Foamix Investigational Site # 108
state: Texas
city: San Antonio
country: United States
facility: Foamix Investigational Site # 208
state: Texas
city: San Antonio
country: United States
facility: Foamix Investigational Site # 213
state: Texas
city: Webster
country: United States
facility: Foamix Investigational Site # 209
state: Texas
city: Salt Lake City
country: United States
facility: Foamix Investigational Site # 126
state: Utah
city: Lynchburg
country: United States
facility: Foamix Investigational Site # 216
state: Virginia
city: Seattle
country: United States
facility: Foamix Investigational Site # 203
state: Washington
Study officials:
References: