A Study (Study 2) to Evaluate the Safety and Efficacy of FMX103 1.5% Topical Minocycline Foam in the Treatment of Facial Papulopustular Rosacea

NCT ID: NCT04608500

Last Updated: 2021-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 771 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2018-07-31

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 # 207

Glendale, Arizona, United States

Foamix Investigational Site # 202

Hot Springs, Arkansas, United States

Foamix Investigational Site # 222

Rogers, Arkansas, United States

Foamix Investigational Site #244

Encino, California, United States

Foamix Investigational Site #249

Huntington Beach, California, United States

Foamix Investigational Site # 226

Los Angeles, California, United States

Foamix Investigational Site # 220

Murrieta, California, United States

Foamix Investigational Site #251

North Hollywood, California, United States

Foamix Investigational Site # 217

San Diego, California, United States

Foamix Investigational Site #250

San Marcos, California, United States

Foamix Investigational Site # 239

Temecula, California, United States

Foamix Investigational Site # 227

Denver, Colorado, United States

Foamix Investigational Site # 223

Boca Raton, Florida, United States

Foamix Investigational Site # 215

Boynton Beach, Florida, United States

Foamix Investigational Site #245

DeLand, Florida, United States

Foamix Investigational Site # 240

Fort Myers, Florida, United States

Foamix Investigational Site #247

Hialeah, Florida, United States

Foamix Investigational Site #252

Hialeah, Florida, United States

Foamix Investigational Site # 214

Miami, Florida, United States

Foamix Investigational Site #246

Miami, Florida, United States

Foamix Investigational Site # 241

North Miami Beach, Florida, United States

Foamix Investigational Site #248

Oldsmar, Florida, United States

Foamix Investigational Site # 204

Newnan, Georgia, United States

Foamix Investigational Site # 211

Arlington Heights, Illinois, United States

Foamix Investigational Site # 225

Newburgh, Indiana, United States

Foamix Investigational Site #243

Plainfield, Indiana, United States

Foamix Investigational Site # 218

South Bend, Indiana, United States

Foamix Investigational Site # 235

Louisville, Kentucky, United States

Foamix Investigational Site # 237

Louisville, Kentucky, United States

Foamix Investigational Site # 229

Watertown, Massachusetts, United States

Foamix Investigational Site # 210

Detroit, Michigan, United States

Foamix Investigational Site # 232

Fridley, Minnesota, United States

Foamix Investigational Site # 238

High Point, North Carolina, United States

Foamix Investigational Site # 212

Raleigh, North Carolina, United States

Foamix Investigational Site # 236

Norman, Oklahoma, United States

Foamix Investigational Site # 224

Exton, Pennsylvania, United States

Foamix Investigational Site # 230

Mt. Pleasant, South Carolina, United States

Foamix Investigational Site # 228

Knoxville, Tennessee, United States

Foamix Investigational Site # 219

Arlington, Texas, United States

Foamix Investigational Site # 201

Houston, Texas, United States

Foamix Investigational Site # 206

Pflugerville, Texas, United States

Foamix Investigational Site # 208

San Antonio, Texas, United States

Foamix Investigational Site # 213

San Antonio, Texas, United States

Foamix Investigational Site # 209

Webster, Texas, United States

Foamix Investigational Site # 216

Lynchburg, Virginia, United States

Foamix Investigational Site # 203

Seattle, Washington, 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

FX2016-12

Identifier Type: -

Identifier Source: org_study_id