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

NCT04608500 | Completed Phase 3 Results FDA Drug

• 1 other identifier: FX2016-12
• Study Type: interventional
• Target: 771
• Locations: 1 country
• Sites: 46

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 (46)

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 #244

Encino, California, 91436, United States

Location

Foamix Investigational Site #249

Huntington Beach, California, 92647, 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 #251

North Hollywood, California, 91606, United States

Location

Foamix Investigational Site # 217

San Diego, California, 92123, United States

Location

Foamix Investigational Site #250

San Marcos, California, 92078, 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 #245

DeLand, Florida, 32720, United States

Location

Foamix Investigational Site # 240

Fort Myers, Florida, 33912, United States

Location

Foamix Investigational Site #247

Hialeah, Florida, 33015, United States

Location

Foamix Investigational Site #252

Hialeah, Florida, 33106, United States

Location

Foamix Investigational Site # 214

Miami, Florida, 33126, United States

Location

Foamix Investigational Site #246

Miami, Florida, 33186, United States

Location

Foamix Investigational Site # 241

North Miami Beach, Florida, 33162, United States

Location

Foamix Investigational Site #248

Oldsmar, Florida, 34677, United States

Location

Foamix Investigational Site # 204

Newnan, Georgia, 78660, United States

Location

Foamix Investigational Site # 211

Arlington Heights, Illinois, 60005, United States

Location

Foamix Investigational Site # 225

Newburgh, Indiana, 47630, United States

Location

Foamix Investigational Site #243

Plainfield, Indiana, 46168, 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 # 229

Watertown, Massachusetts, 02472, United States

Location

Foamix Investigational Site # 210

Detroit, Michigan, 48202, United States

Location

Foamix Investigational Site # 232

Fridley, Minnesota, 55432, 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 # 236

Norman, Oklahoma, 73071, United States

Location

Foamix Investigational Site # 224

Exton, Pennsylvania, 19341, 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 # 201

Houston, Texas, 77004, United States

Location

Foamix Investigational Site # 206

Pflugerville, Texas, 78660, 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 # 216

Lynchburg, Virginia, 24501, United States

Location

Foamix Investigational Site # 203

Seattle, Washington, 98104, 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: October 20, 2020
• First Posted: October 29, 2020
• Study Start: June 1, 2017
• Primary Completion: July 2, 2018
• Study Completion: July 31, 2018
• Last Updated: January 7, 2021
• Results First Posted: December 16, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (46)