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NCT03271021 Clinical Trial

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

Acne Vulgaris Clinical Trial

Official title:
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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03271021
Other study ID # FX2017-22
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date July 17, 2017
Est. completion date September 4, 2018

Study information
Verified date January 2022
Source Vyne Therapeutics Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)

Description:

This is a randomized, multicenter, double-blind, vehicle-controlled, 2 arm study to evaluate the safety and efficacy over 12 weeks of FMX101 topical foam containing 4% minocycline compared to vehicle in the treatment of subjects with moderate-to-severe facial acne vulgaris. Qualified subjects will be randomized to receive 1 of the following 2 treatments: - FMX101 4% minocycline foam - Vehicle foam

Recruitment information / eligibility
Status Completed
Enrollment 1488
Est. completion date September 4, 2018
Est. primary completion date September 4, 2018
Accepts healthy volunteers No
Gender All
Age group 9 Years and older
Eligibility Inclusion Criteria: 1. Has facial acne vulgaris with: 1. 20 to 50 inflammatory lesions (papules, pustules, and nodules) 2. 25 to 100 non-inflammatory lesions (open and closed comedones) 3. No more than 2 nodules on the face 4. IGA score of moderate (3) to severe (4) 2. 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. Exclusion Criteria: 1. 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. 2. Sunburn on the face.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• FMX101
FMX101, 4% minocycline foam
• Vehicle Foam
Vehicle Foam

Locations
Country Name City State
United States Foamix Investigational Site #374 Arlington Texas
United States Foamix Research Site # 301 Arlington Texas
United States Foamix Investigational SIte #341 Austin Texas
United States Foamix Investigational Site #351 Austin Texas
United States Foamix Investigational Site #381 Aventura Florida
United States Foamix Investigational Site #356 Berlin New Jersey
United States Foamix Investigational Site #304 Beverly Massachusetts
United States Foamix Investigational Site #310 Bexley Ohio
United States Foamix Investigational Site #311 Boca Raton Florida
United States Foamix Investigational SIte #371 Boca Raton Florida
United States Foamix Investigational Site #398 Brandon Florida
United States Foamix Investigational Site #314 Brighton Massachusetts
United States Foamix Investigational Site #402 Bryan Texas
United States Foamix Investigational Site #315 Bryant Arkansas
United States Foamix Investigational Site #319 Charleston South Carolina
United States Foamix Investigational Site #321 Charlotte New York
United States Foamix Investigational Site #350 Charlotte North Carolina
United States Foamix Investigational Site #386 Cincinnati Ohio
United States Foamix Investigational Site #329 Clearwater Florida
United States Foamix Investigational Site #353 Cleveland Ohio
United States Foamix Investigational Site #368 Columbus Georgia
United States Foamix Investigational Site #358 Dallas Texas
United States Foamix Investigational Site #378 Davie Florida
United States Foamix Investigational Site #396 DeLand Florida
United States Foamix Investigational Site #392 Doral Florida
United States Foamix Investigational Site #330 Dublin Ohio
United States Foamix Investigational Site #366 Encino California
United States Foamix Investigational Site #335 Exton Pennsylvania
United States Foamix Investigational Site #364 Fargo North Dakota
United States Foamix Investigational Site #318 Fort Myers Florida
United States Foamix Investigational Site #340 Fort Smith Arkansas
United States Foamix Investigational Site #388 Glenn Dale Maryland
United States Foamix Investigational Site #349 Hershey Pennsylvania
United States Foamix Investigational Site #400 Hialeah Florida
United States Foamix Investigational Site #401 Hialeah Florida
United States Foamix Investigational Site #333 Houston Texas
United States Foamix Investigational Site #352 Houston Texas
United States Foamix Investigational Site #365 Indianapolis Indiana
United States Foamix Investigational Site #323 Jenkintown Pennsylvania
United States Foamix Investigational Site #308 Knoxville Tennessee
United States Foamix Investigational Site #383 Lake Worth Florida
United States Foamix Investigational Site #332 Las Vegas Nevada
United States Foamix Investigational Site #391 Lincoln Nebraska
United States Foamix Investigational SIte #377 Little Rock Arkansas
United States Foamix Investigational Site #403 Los Angeles California
United States Foamix Investigational Site #320 Louisville Kentucky
United States Foamix Investigational SIte #367 Louisville Kentucky
United States Foamix Investigational SIte #379 Lynchburg Virginia
United States Foamix Investigational Site #370 Miami Florida
United States Foamix Investigational Site #397 Miami Florida
United States Foamix Investigational Site #346 Miami Lakes Florida
United States Foamix Investigational Site #347 Miami Lakes Florida
United States Foamix Investigational Site #305 Mount Pleasant South Carolina
United States Foamix Investigational Site #303 Murrieta California
United States Foamix Investigational Site #384 Nampa Idaho
United States Foamix Investigational Site #316 New Albany Indiana
United States Foamix Investigational Site #317 New Orleans Louisiana
United States Foamix Investigational SIte #373 New Orleans Louisiana
United States Foamix Investigational Site #355 New York New York
United States Foamix Investigational Site #363 New York New York
United States Foamix Investigational Site #343 Norfolk Virginia
United States Foamix Investigational Site #302 Norman Oklahoma
United States Foamix Investigational Site #306 North Miami Beach Florida
United States Foamix Investigational Site #369 Northridge California
United States Foamix Investigational Site # 327 Omaha Nebraska
United States Foamix Investigational Site #312 Ormond Beach Florida
United States Foamix Investigational Site #387 Palm Springs California
United States Foamix Investigational Site #393 Pasadena California
United States Foamix Investigational Site # 324 Pflugerville Texas
United States Foamix Investigational Site #376 Phoenix Arizona
United States Foamix Investigational Site #361 Plainfield Indiana
United States Foamix Investigational Site #344 Portsmouth New Hampshire
United States Foamix Investigational Site #380 Poway California
United States Foamix Investigational Site # 328 Sacramento California
United States Foamix Investigational Site #322 Saint Joseph Missouri
United States Foamix Investigational Site #372 Saint Louis Missouri
United States Foamix Investigational Site #313 San Diego California
United States Foamix Investigational Site #336 San Luis Obispo California
United States Foamix Investigational Site #336 Sandy Springs Georgia
United States Foamix Investigational Site #309 Santa Ana California
United States Foamix Investigational Site #325 Santa Monica California
United States Foamix Investigational Site #389 Seattle Washington
United States Foamix Investigational Site #345 Skokie Illinois
United States Foamix Investigational Site #331 South Bend Indiana
United States Foamix Investigational Site #362 South Miami Florida
United States Foamix Investigational Site #307 Stony Brook New York
United States Foamix Investigational Site #359 Tacoma Washington
United States Foamix Investigational SIte #382 Tamarac Florida
United States Foamix Investigational Site #385 Tampa Florida
United States Foamix Investigational Site #394 Tampa Florida
United States Foamix Investigational Site #399 Tampa Florida
United States Foamix Investigational Site #375 Temecula California
United States Foamix Investigational Site #395 Tucson Arizona
United States Foamix Investigational Site #337 Verona New Jersey
United States Foamix Investigational Site #334 Watertown Massachusetts
United States Foamix Investigational Site #390 West Dundee Illinois
United States Foamix Investigational Site #360 West Palm Beach Florida
United States Foamix Investigational Site #348 Winston-Salem North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Vyne Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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 The Absolute Change From Baseline in the Non-inflammatory Lesion Count at Week 12 12 weeks
Secondary The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 9 9 weeks
Secondary The Absolute Change From Baseline in the Inflammatory Lesion Count at the Interim Visit at Week 6 6 weeks
Secondary 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
Secondary 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
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