A Study to Evaluate the Efficacy and Safety of Topical Administration of FMX101 in the Treatment of Moderate-to-Severe Acne Vulgaris

NCT03271021 | Completed Phase 3 Results FDA Drug

• 1 other identifier: FX2017-22
• Study Type: interventional
• Target: 1,488
• Locations: 1 country
• Sites: 98

Brief Summary

A Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Efficacy and Safety of Topical Administration of FMX101 for 12 Weeks in the Treatment of Moderate-to-Severe Acne Vulgaris (Study FX2017-22)

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (2)

• The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 12.

  A decrease in the inflammatory lesion count from Baseline to Week 12.

  12 weeks

• Investigator Global Assessment (IGA) Treatment Success (Dichotomized as Yes/no) at Week 12, Where Success is Defined as an IGA Score of 0 or 1, and at Least a 2-grade Improvement (Decrease) From Baseline

  12 weeks

Secondary Outcomes (5)

• The Absolute Change From Baseline in the Non-inflammatory Lesion Count at Week 12

  12 weeks

• The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 9

  9 weeks

• The Absolute Change From Baseline in the Inflammatory Lesion Count at the Interim Visit at Week 6

  6 weeks

• IGA Treatment Success (Dichotomized as Yes/no) at Week 6, Where Success is Defined as an IGA Score of 0 or 1, and at Least a 2-grade Improvement (Decrease) From Baseline at the Interim Visit at Week 6

  6 weeks

• IGA Treatment Success (Dichotomized as Yes/no) at Week 9, Where Success is Defined as an IGA Score of 0 or 1, and at Least a 2-grade Improvement (Decrease) From Baseline at the Interim Visit at Week 9

  9 weeks

Study Arms (2)

FMX101, 4% minocycline foam

EXPERIMENTAL

FMX101, 4% minocycline foam applied topically once daily for 12 weeks

Drug: FMX101

Vehicle foam

PLACEBO COMPARATOR

Vehicle foam applied topically once daily for 12 weeks

Drug: Vehicle Foam

Interventions

FMX101 DRUG

FMX101, 4% minocycline foam

FMX101, 4% minocycline foam

Vehicle Foam DRUG

Vehicle Foam

Vehicle foam

Eligibility Criteria

• Age: 9 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Has facial acne vulgaris with:
• to 50 inflammatory lesions (papules, pustules, and nodules)
• to 100 non-inflammatory lesions (open and closed comedones)
• No more than 2 nodules on the face
• IGA score of moderate (3) to severe (4)
• Willing to use only the supplied non-medicated cleanser (Cetaphil Gentle Skin Cleanser) and to refrain from use of any other acne medication, medicated cleanser, excessive sun exposure, and tanning booths for the duration of the study.

You may not qualify if:

• Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne), or any dermatological condition of the face or facial hair (eg, beard, sideburns, mustache) that could interfere with the clinical evaluations.
• Sunburn on the face.

Sponsors & Collaborators

• Vyne Therapeutics Inc.: lead

Study Sites (98)

Foamix Investigational Site #376

Phoenix, Arizona, 85023, United States

Location

Foamix Investigational Site #395

Tucson, Arizona, 85712, United States

Location

Foamix Investigational Site #315

Bryant, Arkansas, 72022, United States

Location

Foamix Investigational Site #340

Fort Smith, Arkansas, 72916, United States

Location

Foamix Investigational SIte #377

Little Rock, Arkansas, 72212, United States

Location

Foamix Investigational Site #366

Encino, California, 91436, United States

Location

Foamix Investigational Site #403

Los Angeles, California, 90036, United States

Location

Foamix Investigational Site #303

Murrieta, California, 92562, United States

Location

Foamix Investigational Site #369

Northridge, California, 91324, United States

Location

Foamix Investigational Site #387

Palm Springs, California, 92262, United States

Location

Foamix Investigational Site #393

Pasadena, California, 91105, United States

Location

Foamix Investigational Site #380

Poway, California, 92064, United States

Location

Foamix Investigational Site # 328

Sacramento, California, 95819, United States

Location

Foamix Investigational Site #313

San Diego, California, 92123, United States

Location

Foamix Investigational Site #336

San Luis Obispo, California, 93405, United States

Location

Foamix Investigational Site #309

Santa Ana, California, 92705, United States

Location

Foamix Investigational Site #325

Santa Monica, California, 90403, United States

Location

Foamix Investigational Site #375

Temecula, California, 92592, United States

Location

Foamix Investigational Site #381

Aventura, Florida, 33180, United States

Location

Foamix Investigational SIte #371

Boca Raton, Florida, 33431, United States

Location

Foamix Investigational Site #311

Boca Raton, Florida, 33486, United States

Location

Foamix Investigational Site #398

Brandon, Florida, 33511, United States

Location

Foamix Investigational Site #329

Clearwater, Florida, 33756, United States

Location

Foamix Investigational Site #378

Davie, Florida, 33328, United States

Location

Foamix Investigational Site #396

DeLand, Florida, 32720, United States

Location

Foamix Investigational Site #392

Doral, Florida, 33126, United States

Location

Foamix Investigational Site #318

Fort Myers, Florida, 33912, United States

Location

Foamix Investigational Site #401

Hialeah, Florida, 33015, United States

Location

Foamix Investigational Site #400

Hialeah, Florida, 33016, United States

Location

Foamix Investigational Site #383

Lake Worth, Florida, 33467, United States

Location

Foamix Investigational Site #397

Miami, Florida, 33126, United States

Location

Foamix Investigational Site #370

Miami, Florida, 33155, United States

Location

Foamix Investigational Site #346

Miami Lakes, Florida, 33016, United States

Location

Foamix Investigational Site #347

Miami Lakes, Florida, 33104, United States

Location

Foamix Investigational Site #306

North Miami Beach, Florida, 33162, United States

Location

Foamix Investigational Site #312

Ormond Beach, Florida, 32174, United States

Location

Foamix Investigational Site #362

South Miami, Florida, 33143, United States

Location

Foamix Investigational SIte #382

Tamarac, Florida, 33321, United States

Location

Foamix Investigational Site #399

Tampa, Florida, 33609, United States

Location

Foamix Investigational Site #385

Tampa, Florida, 33624, United States

Location

Foamix Investigational Site #394

Tampa, Florida, 33634, United States

Location

Foamix Investigational Site #360

West Palm Beach, Florida, 33406, United States

Location

Foamix Investigational Site #368

Columbus, Georgia, 31904, United States

Location

Foamix Investigational Site #336

Sandy Springs, Georgia, 30328, United States

Location

Foamix Investigational Site #384

Nampa, Idaho, 83651, United States

Location

Foamix Investigational Site #345

Skokie, Illinois, 60077, United States

Location

Foamix Investigational Site #390

West Dundee, Illinois, 60118, United States

Location

Foamix Investigational Site #365

Indianapolis, Indiana, 46256, United States

Location

Foamix Investigational Site #316

New Albany, Indiana, 47150, United States

Location

Foamix Investigational Site #361

Plainfield, Indiana, 46168, United States

Location

Foamix Investigational Site #331

South Bend, Indiana, 46617, United States

Location

Foamix Investigational Site #320

Louisville, Kentucky, 40217, United States

Location

Foamix Investigational SIte #367

Louisville, Kentucky, 40241, United States

Location

Foamix Investigational Site #317

New Orleans, Louisiana, 70115, United States

Location

Foamix Investigational SIte #373

New Orleans, Louisiana, 70124, United States

Location

Foamix Investigational Site #388

Glenn Dale, Maryland, 20769, United States

Location

Foamix Investigational Site #304

Beverly, Massachusetts, 01915, United States

Location

Foamix Investigational Site #314

Brighton, Massachusetts, 02135, United States

Location

Foamix Investigational Site #334

Watertown, Massachusetts, 02472, United States

Location

Foamix Investigational Site #322

Saint Joseph, Missouri, 64506, United States

Location

Foamix Investigational Site #372

St Louis, Missouri, 63141, United States

Location

Foamix Investigational Site #391

Lincoln, Nebraska, 68502, United States

Location

Foamix Investigational Site # 327

Omaha, Nebraska, 68144, United States

Location

Foamix Investigational Site #332

Las Vegas, Nevada, 89728, United States

Location

Foamix Investigational Site #344

Portsmouth, New Hampshire, 03801, United States

Location

Foamix Investigational Site #356

Berlin, New Jersey, 08009, United States

Location

Foamix Investigational Site #337

Verona, New Jersey, 07044, United States

Location

Foamix Investigational Site #321

Charlotte, New York, 28277, United States

Location

Foamix Investigational Site #355

New York, New York, 10016, United States

Location

Foamix Investigational Site #363

New York, New York, 10155, United States

Location

Foamix Investigational Site #307

Stony Brook, New York, 11790, United States

Location

Foamix Investigational Site #350

Charlotte, North Carolina, 28277, United States

Location

Foamix Investigational Site #348

Winston-Salem, North Carolina, 27104, United States

Location

Foamix Investigational Site #364

Fargo, North Dakota, 58103, United States

Location

Foamix Investigational Site #310

Bexley, Ohio, 43209, United States

Location

Foamix Investigational Site #386

Cincinnati, Ohio, 45212, United States

Location

Foamix Investigational Site #353

Cleveland, Ohio, 44122, United States

Location

Foamix Investigational Site #330

Dublin, Ohio, 43016, United States

Location

Foamix Investigational Site #302

Norman, Oklahoma, 73071, United States

Location

Foamix Investigational Site #335

Exton, Pennsylvania, 19341, United States

Location

Foamix Investigational Site #349

Hershey, Pennsylvania, 17033, United States

Location

Foamix Investigational Site #323

Jenkintown, Pennsylvania, 19046, United States

Location

Foamix Investigational Site #319

Charleston, South Carolina, 29407, United States

Location

Foamix Investigational Site #305

Mt. Pleasant, South Carolina, 29464, United States

Location

Foamix Investigational Site #308

Knoxville, Tennessee, 37922, United States

Location

Foamix Research Site # 301

Arlington, Texas, 76011, United States

Location

Foamix Investigational Site #374

Arlington, Texas, 76014, United States

Location

Foamix Investigational SIte #341

Austin, Texas, 78704, United States

Location

Foamix Investigational Site #351

Austin, Texas, 78705, United States

Location

Foamix Investigational Site #402

Bryan, Texas, 77802, United States

Location

Foamix Investigational Site #358

Dallas, Texas, 75231, United States

Location

Foamix Investigational Site #333

Houston, Texas, 77004, United States

Location

Foamix Investigational Site #352

Houston, Texas, 77056, United States

Location

Foamix Investigational Site # 324

Pflugerville, Texas, 78660, United States

Location

Foamix Investigational SIte #379

Lynchburg, Virginia, 24501, United States

Location

Foamix Investigational Site #343

Norfolk, Virginia, 235070, United States

Location

Foamix Investigational Site #389

Seattle, Washington, 98168, United States

Location

Foamix Investigational Site #359

Tacoma, Washington, 98405, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Minocycline

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Results Point of Contact

• Title: Senior Director, Clinical Operations
• Organization: Foamix Pharmaceuticals

kendra.gulbronson@foamix.com

9089630117

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2017
• First Posted: September 1, 2017
• Study Start: July 17, 2017
• Primary Completion: September 4, 2018
• Study Completion: September 4, 2018
• Last Updated: January 18, 2022
• Results First Posted: February 21, 2020

Record last verified: 2022-01

Locations

US (98)