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

NCT03276936 | Completed Phase 3 Results FDA Drug

• 1 other identifier: FX2016-13
• Study Type: interventional
• Target: 504
• Locations: 1 country
• Sites: 79

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.

Conditions

Papulopustular Rosacea

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Absolute Change From Baseline in Inflammatory Lesion Count at Weeks 4, 10, 16, 22, 28, and 34

  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

  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

  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

  At Week 40

• Number of Participants With Adverse Events (AEs)

  Day 0/ Baseline (Final visit of previous DB study [Week 12]) until safety follow-up (Week 44)

Study Arms (1)

Minocycline Foam 1.5%

EXPERIMENTAL

FMX-103

Drug: FMX103 1.5%

Interventions

FMX103 1.5% DRUG

FMX103 1.5% minocycline foam

Minocycline Foam 1.5%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vyne Therapeutics Inc.: lead

Study Sites (79)

Foamix Investigational Site # 207

Glendale, Arizona, 85308, United States

Location

Foamix Investigational Site # 202

Hot Springs, Arkansas, 71913, United States

Location

Foamix Investigational Site # 222

Rogers, Arkansas, 72758, United States

Location

Foamix Investigational Site # 127

Fremont, California, 94538, United States

Location

Foamix Investigational Site # 226

Los Angeles, California, 90045, United States

Location

Foamix Investigational Site # 220

Murrieta, California, 92562, United States

Location

Foamix Investigational Site # 131

Oceanside, California, 92056, United States

Location

Foamix Investigational Site # 134

Sacramento, California, 95819, United States

Location

Foamix Investigational Site # 114

San Diego, California, 92123, United States

Location

Foamix Investigational Site # 116

San Luis Obispo, California, 93405, United States

Location

Foamix Investigational Site # 135

Santa Ana, California, 92705, United States

Location

Foamix Investigational Site # 123

Santa Monica, California, 90403, United States

Location

Foamix Investigational Site # 239

Temecula, California, 92592, United States

Location

Foamix Investigational Site # 227

Denver, Colorado, 80209, United States

Location

Foamix Investigational Site # 223

Boca Raton, Florida, 33486, United States

Location

Foamix Investigational Site # 215

Boynton Beach, Florida, 33437, United States

Location

Foamix Investigational Site # 109

Clearwater, Florida, 33757, United States

Location

Foamix Investigational Site # 240

Fort Myers, Florida, 33912, United States

Location

Foamix Investigational Site # 112

Hialeah, Florida, 33016, United States

Location

Foamix Investigational Site # 214

Miami, Florida, 33126, United States

Location

Foamix Investigational Site # 241

North Miami Beach, Florida, 33162, United States

Location

Foamix Investigational Site # 104

Ormond Beach, Florida, 32174, United States

Location

Foamix Investigational Site # 121

Sanford, Florida, 32771, United States

Location

Foamix Investigational Site # 125

Tampa, Florida, 33609, United States

Location

Foamix Investigational Site # 124

West Palm Beach, Florida, 33409, United States

Location

Foamix Investigational Site # 118

Alpharetta, Georgia, 30022, United States

Location

Foamix Investigational Site # 204

Newnan, Georgia, 78660, United States

Location

Foamix Investigational Site # 233

Sandy Springs, Georgia, 30328, United States

Location

Foamix Investigational Site # 139

Snellville, Georgia, 30078, United States

Location

Foamix Investigational Site # 211

Arlington Heights, Illinois, 60005, United States

Location

Foamix Investigational Site # 138

New Albany, Indiana, 47150, United States

Location

Foamix Investigational Site # 225

Newburgh, Indiana, 47630, United States

Location

Foamix Investigational Site # 218

South Bend, Indiana, 46617, United States

Location

Foamix Investigational Site # 235

Louisville, Kentucky, 40217, United States

Location

Foamix Investigational Site # 237

Louisville, Kentucky, 40241, United States

Location

Foamix Investigational Site # 102

Metairie, Louisiana, 70006, United States

Location

Foamix Investigational Site # 115

New Orleans, Louisiana, 70115, United States

Location

Foamix Investigational Site # 110

Beverly, Massachusetts, 01915, United States

Location

Foamix Investigational Site # 107

Brighton, Massachusetts, 02135, United States

Location

Foamix Investigational Site # 229

Watertown, Massachusetts, 02472, United States

Location

Foamix Investigational Site # 137

Ann Arbor, Michigan, 48103, United States

Location

Foamix Investigational Site # 242

Bay City, Michigan, 48706, United States

Location

Foamix Investigational Site # 210

Detroit, Michigan, 48202, United States

Location

Foamix Investigational Site # 103

Fort Gratiot, Michigan, 48059, United States

Location

Foamix Investigational Site # 120

Troy, Michigan, 48084, United States

Location

Foamix Investigational Site # 140

Warren, Michigan, 48088, United States

Location

Foamix Investigational Site # 232

Fridley, Minnesota, 55432, United States

Location

Foamix Investigational Site # 130

Saint Joseph, Missouri, 64506, United States

Location

Foamix Investigational Site # 133

Omaha, Nebraska, 68144, United States

Location

Foamix Investigational Site # 221

Las Vegas, Nevada, 89128, United States

Location

Foamix Investigational Site # 136

New York, New York, 10075, United States

Location

Foamix Investigational Site # 111

Stony Brook, New York, 11790, United States

Location

Foamix Investigational Site # 119

Charlotte, North Carolina, 28277, United States

Location

Foamix Investigational Site # 238

High Point, North Carolina, 27262, United States

Location

Foamix Investigational Site # 212

Raleigh, North Carolina, 27612, United States

Location

Foamix Investigational Site # 234

Winston-Salem, North Carolina, 27103, United States

Location

Foamix Investigational Site # 101

Bexley, Ohio, 43209, United States

Location

Foamix Investigational Site # 128

Dublin, Ohio, 43016, United States

Location

Foamix Investigational Site # 236

Norman, Oklahoma, 73071, United States

Location

Foamix Investigational Site # 224

Exton, Pennsylvania, 19341, United States

Location

Foamix Investigational Site # 141

Jenkintown, Pennsylvania, 19046, United States

Location

Foamix Investigational Site # 129

Yardley, Pennsylvania, 19067, United States

Location

Foamix Investigational Site # 105

Johnston, Rhode Island, 02919, United States

Location

Foamix Investigational Site # 231

Charleston, South Carolina, 29407, United States

Location

Foamix Investigational Site # 106

Greenville, South Carolina, 29607, United States

Location

Foamix Investigational Site # 230

Mt. Pleasant, South Carolina, 29464, United States

Location

Foamix Investigational Site # 228

Knoxville, Tennessee, 37922, United States

Location

Foamix Investigational Site # 219

Arlington, Texas, 76011, United States

Location

Foamix Investigational Site # 132

Austin, Texas, 78746, United States

Location

Foamix Investigational Site # 117

Austin, Texas, 78759, United States

Location

Foamix Investigational Site # 201

Houston, Texas, 77004, United States

Location

Foamix Investigational Site # 206

Pflugerville, Texas, 78660, United States

Location

Foamix Investigational Site # 108

San Antonio, Texas, 78213, United States

Location

Foamix Investigational Site # 208

San Antonio, Texas, 78229, United States

Location

Foamix Investigational Site # 213

San Antonio, Texas, 78229, United States

Location

Foamix Investigational Site # 209

Webster, Texas, 77598, United States

Location

Foamix Investigational Site # 126

Salt Lake City, Utah, 84117, United States

Location

Foamix Investigational Site # 216

Lynchburg, Virginia, 24501, United States

Location

Foamix Investigational Site # 203

Seattle, Washington, 98104, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Rosacea

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Iain Stuart, PhD.
• Organization: Foamix Pharmaceuticals, Inc.

Iain.Stuart@foamix.com

1 800-775-7936

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2017
• First Posted: September 8, 2017
• Study Start: September 5, 2017
• Primary Completion: January 3, 2019
• Study Completion: January 15, 2019
• Last Updated: January 18, 2022
• Results First Posted: December 29, 2020

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (79)