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

NCT ID: NCT03142451

Last Updated: 2021-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 751 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-02
• Study Completion Date: 2018-09-28

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.

Detailed Description

This is a randomized, multicenter, double-blind, vehicle-controlled, 2 arm study to evaluate the safety and efficacy of FMX103 topical foam containing 1.5% minocycline compared to vehicle, in the treatment of participants with moderate-to-severe facial papulopustular rosacea. Qualified participants will be randomized in a 2:1 ratio (active:vehicle) to receive 1 of the following 2 treatments:

• FMX103 minocycline foam 1.5%
• Vehicle foam

Participants will be assigned to 1 of 2 treatments according to the randomization schedule. Participants will apply (or have applied) the study drug topically once daily for 12 weeks as directed. Participants will be advised to use the study drug at approximately the same time each day. Both the Investigator and participant will be blinded to the study drug identity. Participants will return for visits at Weeks 1, 4, 6, 8, 10, and 12. Efficacy evaluations (inflammatory lesion counts and Investigator's Global Assessment [IGA] score) will be performed at Weeks 4, 8, and 12 during the study.

Note: Originally the two studies FX2016-11 and FX2016-12 were combinedly presented in the protocol registration form under one NCT number (NCT03142451), and later separated since results were analyzed separately.

Conditions

Facial Papulopustular Rosacea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

FMX103 1.5%

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

Group Type: EXPERIMENTAL

FMX103 minocycline foam 1.5%

Intervention Type: 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.

Vehicle foam

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

Group Type: PLACEBO_COMPARATOR

Vehicle foam

Intervention Type: 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.

Interventions

FMX103 minocycline foam 1.5%

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.

Intervention Type: DRUG

Vehicle foam

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Moderate-to-severe rosacea (as per the IGA score) on the proposed facial treatment area consisting of:

1. At least 15 and not more than 75 facial papules and pustules, excluding lesions involving the eyes and scalp;

2. No more than 2 nodules on the face.

2. Presence of or history of erythema and/or flushing on the face.

Exclusion Criteria

1. Presence of any skin condition and/or Excessive facial hair, on the face that would interfere with the diagnosis or assessment of rosacea.

2. Moderate or severe rhinophyma, dense telangiectasia (score 3, severe), or plaque-like facial edema.

3. History of hypersensitivity or allergy to minocycline, any other tetracycline, or of any other component of the formulation.

4. Active ocular rosacea (eg, conjunctivitis, blepharitis, or keratitis) of sufficient severity to require topical or systemic antibiotics.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Premier Research Group plc

UNKNOWN

Sponsor Role: collaborator

Vyne Therapeutics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Foamix Investigational Site #152

Tucson, Arizona, United States

Foamix Investigational Site # 127

Fremont, California, United States

Foamix Investigational Site #155

Los Angeles, California, United States

Foamix Investigational Site #143

Northridge, California, United States

Foamix Investigational Site # 131

Oceanside, California, United States

Foamix Investigational Site #156

Oceanside, California, United States

Foamix Investigational Site #153

San Diego, California, United States

Foamix Investigational Site # 114

San Diego, California, United States

Foamix Investigational Site # 116

San Luis Obispo, California, United States

Foamix Investigational Site # 135

Santa Ana, California, United States

Foamix Investigational Site # 123

Santa Monica, California, United States

Foamix Investigational Site # 109

Clearwater, Florida, United States

Foamix Investigational Site # 112

Hialeah, Florida, United States

Foamix Investigational Site #150

Lake Worth, Florida, United States

Foamix Investigational Site #149

Miami, Florida, United States

Foamix Investigational Site #151

Miami, Florida, United States

Foamix Investigational Site #144

Miami Lakes, Florida, United States

Foamix Investigational Site # 104

Ormond Beach, Florida, United States

Foamix Investigational Site # 121

Sanford, Florida, United States

Foamix Investigational Site #154

Sweetwater, Florida, United States

Foamix Investigational Site # 125

Tampa, Florida, United States

Foamix Investigational Site # 142

West Palm Beach, Florida, United States

Foamix Investigational Site # 124

West Palm Beach, Florida, United States

Foamix Investigational Site # 118

Alpharetta, Georgia, United States

Foamix Investigational Site # 139

Snellville, Georgia, United States

Foamix Investigational Site # 138

New Albany, Indiana, United States

Foamix Investigational Site # 102

Metairie, Louisiana, United States

Foamix Investigational Site # 115

New Orleans, Louisiana, United States

Foamix Investigational Site # 110

Beverly, Massachusetts, United States

Foamix Investigational Site # 107

Brighton, Massachusetts, United States

Foamix Investigational Site # 137

Ann Arbor, Michigan, United States

Foamix Investigational Site # 103

Fort Gratiot, Michigan, United States

Foamix Investigational Site # 120

Troy, Michigan, United States

Foamix Investigational Site # 140

Warren, Michigan, United States

Foamix Investigational Site # 130

Saint Joseph, Missouri, United States

Foamix Investigational Site # 133

Omaha, Nebraska, United States

Foamix Investigational Site #146

Las Vegas, Nevada, United States

Foamix Investigational Site # 136

New York, New York, United States

Foamix Investigational Site #145

New York, New York, United States

Foamix Investigational Site # 111

Stony Brook, New York, United States

Foamix Investigational Site # 119

Charlotte, North Carolina, United States

Foamix Investigational Site # 101

Bexley, Ohio, United States

Foamix Investigational Site # 128

Dublin, Ohio, United States

Foamix Investigational Site #147

Broomall, Pennsylvania, United States

Foamix Investigational Site # 141

Jenkintown, Pennsylvania, United States

Foamix Investigational Site #157

Saint Clair, Pennsylvania, United States

Foamix Investigational Site # 129

Yardley, Pennsylvania, United States

Foamix Investigational Site # 105

Johnston, Rhode Island, United States

Foamix Investigational Site # 106

Greenville, South Carolina, United States

Foamix Investigational Site # 122

Murfreesboro, Tennessee, United States

Foamix Investigational Site # 117

Austin, Texas, United States

Foamix Investigational Site #159

Houston, Texas, United States

Foamix Investigational Site # 108

San Antonio, Texas, United States

Foamix Investigational Site # 126

Salt Lake City, Utah, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Study Documents

Document Type: Study Protocol

View Document

Other Identifiers

FX2016-11

Identifier Type: -

Identifier Source: org_study_id