A Study to Evaluate the Long-Term Safety of Topical Administration of FMX103 in the Treatment of Moderate to Severe Papulopustular Rosacea

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.

Study Overview

• Status: Completed
• Conditions: Papulopustular Rosacea
• Intervention / Treatment: Drug: FMX103 1.5%

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.

• Study Type: Interventional
• Enrollment (Actual): 504
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Glendale, Arizona, United States, 85308
      • Foamix Investigational Site # 207
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • Foamix Investigational Site # 202
    • Rogers, Arkansas, United States, 72758
      • Foamix Investigational Site # 222
  • California
    • Fremont, California, United States, 94538
      • Foamix Investigational Site # 127
    • Los Angeles, California, United States, 90045
      • Foamix Investigational Site # 226
    • Murrieta, California, United States, 92562
      • Foamix Investigational Site # 220
    • Oceanside, California, United States, 92056
      • Foamix Investigational Site # 131
    • Sacramento, California, United States, 95819
      • Foamix Investigational Site # 134
    • San Diego, California, United States, 92123
      • Foamix Investigational Site # 114
    • San Luis Obispo, California, United States, 93405
      • Foamix Investigational Site # 116
    • Santa Ana, California, United States, 92705
      • Foamix Investigational Site # 135
    • Santa Monica, California, United States, 90403
      • Foamix Investigational Site # 123
    • Temecula, California, United States, 92592
      • Foamix Investigational Site # 239
  • Colorado
    • Denver, Colorado, United States, 80209
      • Foamix Investigational Site # 227
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Foamix Investigational Site # 223
    • Boynton Beach, Florida, United States, 33437
      • Foamix Investigational Site # 215
    • Clearwater, Florida, United States, 33757
      • Foamix Investigational Site # 109
    • Fort Myers, Florida, United States, 33912
      • Foamix Investigational Site # 240
    • Hialeah, Florida, United States, 33016
      • Foamix Investigational Site # 112
    • Miami, Florida, United States, 33126
      • Foamix Investigational Site # 214
    • North Miami Beach, Florida, United States, 33162
      • Foamix Investigational Site # 241
    • Ormond Beach, Florida, United States, 32174
      • Foamix Investigational Site # 104
    • Sanford, Florida, United States, 32771
      • Foamix Investigational Site # 121
    • Tampa, Florida, United States, 33609
      • Foamix Investigational Site # 125
    • West Palm Beach, Florida, United States, 33409
      • Foamix Investigational Site # 124
  • Georgia
    • Alpharetta, Georgia, United States, 30022
      • Foamix Investigational Site # 118
    • Newnan, Georgia, United States, 78660
      • Foamix Investigational Site # 204
    • Sandy Springs, Georgia, United States, 30328
      • Foamix Investigational Site # 233
    • Snellville, Georgia, United States, 30078
      • Foamix Investigational Site # 139
  • Illinois
    • Arlington Heights, Illinois, United States, 60005
      • Foamix Investigational Site # 211
  • Indiana
    • New Albany, Indiana, United States, 47150
      • Foamix Investigational Site # 138
    • Newburgh, Indiana, United States, 47630
      • Foamix Investigational Site # 225
    • South Bend, Indiana, United States, 46617
      • Foamix Investigational Site # 218
  • Kentucky
    • Louisville, Kentucky, United States, 40217
      • Foamix Investigational Site # 235
    • Louisville, Kentucky, United States, 40241
      • Foamix Investigational Site # 237
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • Foamix Investigational Site # 102
    • New Orleans, Louisiana, United States, 70115
      • Foamix Investigational Site # 115
  • Massachusetts
    • Beverly, Massachusetts, United States, 01915
      • Foamix Investigational Site # 110
    • Brighton, Massachusetts, United States, 02135
      • Foamix Investigational Site # 107
    • Watertown, Massachusetts, United States, 02472
      • Foamix Investigational Site # 229
  • Michigan
    • Ann Arbor, Michigan, United States, 48103
      • Foamix Investigational Site # 137
    • Bay City, Michigan, United States, 48706
      • Foamix Investigational Site # 242
    • Detroit, Michigan, United States, 48202
      • Foamix Investigational Site # 210
    • Fort Gratiot, Michigan, United States, 48059
      • Foamix Investigational Site # 103
    • Troy, Michigan, United States, 48084
      • Foamix Investigational Site # 120
    • Warren, Michigan, United States, 48088
      • Foamix Investigational Site # 140
  • Minnesota
    • Fridley, Minnesota, United States, 55432
      • Foamix Investigational Site # 232
  • Missouri
    • Saint Joseph, Missouri, United States, 64506
      • Foamix Investigational Site # 130
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Foamix Investigational Site # 133
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • Foamix Investigational Site # 221
  • New York
    • New York, New York, United States, 10075
      • Foamix Investigational Site # 136
    • Stony Brook, New York, United States, 11790
      • Foamix Investigational Site # 111
  • North Carolina
    • Charlotte, North Carolina, United States, 28277
      • Foamix Investigational Site # 119
    • High Point, North Carolina, United States, 27262
      • Foamix Investigational Site # 238
    • Raleigh, North Carolina, United States, 27612
      • Foamix Investigational Site # 212
    • Winston-Salem, North Carolina, United States, 27103
      • Foamix Investigational Site # 234
  • Ohio
    • Bexley, Ohio, United States, 43209
      • Foamix Investigational Site # 101
    • Dublin, Ohio, United States, 43016
      • Foamix Investigational Site # 128
  • Oklahoma
    • Norman, Oklahoma, United States, 73071
      • Foamix Investigational Site # 236
  • Pennsylvania
    • Exton, Pennsylvania, United States, 19341
      • Foamix Investigational Site # 224
    • Jenkintown, Pennsylvania, United States, 19046
      • Foamix Investigational Site # 141
    • Yardley, Pennsylvania, United States, 19067
      • Foamix Investigational Site # 129
  • Rhode Island
    • Johnston, Rhode Island, United States, 02919
      • Foamix Investigational Site # 105
  • South Carolina
    • Charleston, South Carolina, United States, 29407
      • Foamix Investigational Site # 231
    • Greenville, South Carolina, United States, 29607
      • Foamix Investigational Site # 106
    • Mount Pleasant, South Carolina, United States, 29464
      • Foamix Investigational Site # 230
  • Tennessee
    • Knoxville, Tennessee, United States, 37922
      • Foamix Investigational Site # 228
  • Texas
    • Arlington, Texas, United States, 76011
      • Foamix Investigational Site # 219
    • Austin, Texas, United States, 78759
      • Foamix Investigational Site # 117
    • Austin, Texas, United States, 78746
      • Foamix Investigational Site # 132
    • Houston, Texas, United States, 77004
      • Foamix Investigational Site # 201
    • Pflugerville, Texas, United States, 78660
      • Foamix Investigational Site # 206
    • San Antonio, Texas, United States, 78213
      • Foamix Investigational Site # 108
    • San Antonio, Texas, United States, 78229
      • Foamix Investigational Site # 208
    • San Antonio, Texas, United States, 78229
      • Foamix Investigational Site # 213
    • Webster, Texas, United States, 77598
      • Foamix Investigational Site # 209
  • Utah
    • Salt Lake City, Utah, United States, 84117
      • Foamix Investigational Site # 126
  • Virginia
    • Lynchburg, Virginia, United States, 24501
      • Foamix Investigational Site # 216
  • Washington
    • Seattle, Washington, United States, 98104
      • Foamix Investigational Site # 203

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Minocycline Foam 1.5%; FMX-103	Drug: FMX103 1.5%; FMX103 1.5% minocycline foam

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 0/ Baseline (Final visit of previous DB study [Week 12]) and at Week 40
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.	At Week 40

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 0/ Baseline (Final visit of previous DB study [Week 12]) and at Weeks 4, 10, 16, 22, 28, and 34
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.	At Weeks 4, 10, 16, 22, 28 and Week 34
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.	Day 0/ Baseline (Final visit of previous DB study [Week 12]) and at Weeks 4, 10, 16, 22, 28, and 34
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.	At Week 40
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.	Day 0/ Baseline (Final visit of previous DB study [Week 12]) until safety follow-up (Week 44)

Collaborators and Investigators

• Sponsor: Vyne Therapeutics Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2017
• Primary Completion (Actual): January 3, 2019
• Study Completion (Actual): January 15, 2019

Study Registration Dates

• First Submitted: August 21, 2017
• First Submitted That Met QC Criteria: September 6, 2017
• First Posted (Actual): September 8, 2017

Study Record Updates

• Last Update Posted (Actual): January 18, 2022
• Last Update Submitted That Met QC Criteria: January 13, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Rosacea
• Other Study ID Numbers: FX2016-13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No