A Study (Study 1) to Evaluate the Safety and Efficacy of FMX103 1.5% Topical Minocycline Foam in the Treatment of Facial Papulopustular Rosacea

NCT03142451 | Completed Phase 3 Results FDA Drug

• 1 other identifier: FX2016-11
• Study Type: interventional
• Target: 751
• Locations: 1 country
• Sites: 54

Brief Summary

The primary objectives of this study are to determine the efficacy and safety of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea.

Conditions

Facial Papulopustular Rosacea

Keywords

Topical Minocycline Foam; 2-Arm study; Inflammatory lesion counts; Investigator's Global Assessment score

Outcome Measures

Primary Outcomes (2)

• The Absolute Change From Day 0/Baseline in the Inflammatory Lesion Count at Week 12

  To determine the efficacy of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea. Lesion counts included the number of papules, pustules, and nodules. Change from Baseline was calculated as the value at Baseline minus the post-Baseline value. Thus, a positive change reflects a reduction in lesion count.

  Baseline and Week 12

• Percentage of Participants Achieving Investigator Global Assessments (IGA) Treatment Success at Week 12

  To determine the efficacy of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea. The Investigator assessed the global severity of rosacea using the IGA scale. 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 (clear) or 1 (almost clear), and at least a 2-step improvement (decrease) from Day 0/Baseline.

  Week 12

Secondary Outcomes (5)

• Percentage of Participants Achieving IGA Treatment Success of at Least 2 Grades at Week 12

  Week 12

• The Percent Change From Day 0/Baseline in Inflammatory Lesion Count at Week 12

  Baseline and Week 12

• The Absolute Change From Day 0/Baseline in the Inflammatory Lesion Counts at Week 4 and Week 8

  Baseline, Week 4 and Week 8

• Percentage of Participants Achieving IGA Treatment Success at Week 4 and Week 8

  Week 4 and Week 8

• Number of Participants With Adverse Events (AEs)

  From Day 0/Baseline until the Safety Follow-up (4 weeks after Week 12 [Final Visit])

Study Arms (2)

FMX103 1.5%

EXPERIMENTAL

Participants will apply the assigned FMX103 minocycline foam 1.5% topically once daily for 12 weeks as directed.

Drug: FMX103 minocycline foam 1.5%

Vehicle foam

PLACEBO COMPARATOR

Participants will apply the assigned vehicle foam topically once daily for 12 weeks as directed.

Drug: Vehicle foam

Interventions

FMX103 minocycline foam 1.5% DRUG

Dosage form description: Foam containing minocycline HCl 1.5%. Once daily application of a sufficient amount of foam to cover the entire face. Estimated maximum is 0.5 g of drug product containing 7.5 mg (1.5% active) of minocycline. Participants will apply a small amount of the drug as a thin layer over all areas of the face. Participants should apply the drug at approximately the same time each day, about 1 hour before bedtime.

FMX103 1.5%

Vehicle foam DRUG

Dosage form description: Foam containing minocycline vehicle foam. Once daily application of a sufficient amount of foam to cover the entire face. Estimated maximum is 0.5 g of drug product containing 0.0 mg (vehicle) of minocycline. Participants will apply a small amount of the drug as a thin layer over all areas of the face. Participants should apply the drug at approximately the same time each day, about 1 hour before bedtime.

Vehicle foam

Eligibility Criteria

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

You may qualify if:

• Moderate-to-severe rosacea (as per the IGA score) on the proposed facial treatment area consisting of:
• At least 15 and not more than 75 facial papules and pustules, excluding lesions involving the eyes and scalp;
• No more than 2 nodules on the face.
• Presence of or history of erythema and/or flushing on the face.

You may not qualify if:

• Presence of any skin condition and/or Excessive facial hair, on the face that would interfere with the diagnosis or assessment of rosacea.
• Moderate or severe rhinophyma, dense telangiectasia (score 3, severe), or plaque-like facial edema.
• History of hypersensitivity or allergy to minocycline, any other tetracycline, or of any other component of the formulation.
• Active ocular rosacea (eg, conjunctivitis, blepharitis, or keratitis) of sufficient severity to require topical or systemic antibiotics.

Sponsors & Collaborators

• Vyne Therapeutics Inc.: lead
• Premier Research: collaborator

Study Sites (54)

Foamix Investigational Site #152

Tucson, Arizona, 85712, United States

Location

Foamix Investigational Site # 127

Fremont, California, 94538, United States

Location

Foamix Investigational Site #155

Los Angeles, California, 90036, United States

Location

Foamix Investigational Site #143

Northridge, California, 91324, United States

Location

Foamix Investigational Site # 131

Oceanside, California, 92056, United States

Location

Foamix Investigational Site #156

Oceanside, California, 92056, United States

Location

Foamix Investigational Site #153

San Diego, California, 92103, 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 # 109

Clearwater, Florida, 33757, United States

Location

Foamix Investigational Site # 112

Hialeah, Florida, 33016, United States

Location

Foamix Investigational Site #150

Lake Worth, Florida, 33467, United States

Location

Foamix Investigational Site #149

Miami, Florida, 33126, United States

Location

Foamix Investigational Site #151

Miami, Florida, 33144, United States

Location

Foamix Investigational Site #144

Miami Lakes, Florida, 33016, 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 #154

Sweetwater, Florida, 33172, United States

Location

Foamix Investigational Site # 125

Tampa, Florida, 33609, United States

Location

Foamix Investigational Site # 142

West Palm Beach, Florida, 33406, 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 # 139

Snellville, Georgia, 30078, United States

Location

Foamix Investigational Site # 138

New Albany, Indiana, 47150, 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 # 137

Ann Arbor, Michigan, 48103, 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 # 130

Saint Joseph, Missouri, 64506, United States

Location

Foamix Investigational Site # 133

Omaha, Nebraska, 68144, United States

Location

Foamix Investigational Site #146

Las Vegas, Nevada, 89148, United States

Location

Foamix Investigational Site # 136

New York, New York, 10075, United States

Location

Foamix Investigational Site #145

New York, New York, 10155, 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 # 101

Bexley, Ohio, 43209, United States

Location

Foamix Investigational Site # 128

Dublin, Ohio, 43016, United States

Location

Foamix Investigational Site #147

Broomall, Pennsylvania, 19008, United States

Location

Foamix Investigational Site # 141

Jenkintown, Pennsylvania, 19046, United States

Location

Foamix Investigational Site #157

Saint Clair, Pennsylvania, 15241, 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 # 106

Greenville, South Carolina, 29607, United States

Location

Foamix Investigational Site # 122

Murfreesboro, Tennessee, 37130, United States

Location

Foamix Investigational Site # 117

Austin, Texas, 78759, United States

Location

Foamix Investigational Site #159

Houston, Texas, 77074, United States

Location

Foamix Investigational Site # 108

San Antonio, Texas, 78213, United States

Location

Foamix Investigational Site # 126

Salt Lake City, Utah, 84117, United States

Location

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: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This is a double-blind study, with limited access to the randomization code. The randomization code will be held in confidence until after the study database is locked and a memo documenting the database lock has been issued. Every effort will be made to retain the integrity of the blind. When issued to the sites, the study drug will be identical in appearance for all participants, regardless of treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2017
• First Posted: May 5, 2017
• Study Start: June 2, 2017
• Primary Completion: August 31, 2018
• Study Completion: September 28, 2018
• Last Updated: January 29, 2021
• Results First Posted: December 17, 2020

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (54)