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

PHASE3CompletedINTERVENTIONAL
Enrollment

751

Participants

Timeline

Start Date

June 2, 2017

Primary Completion Date

August 31, 2018

Study Completion Date

September 28, 2018

Conditions
Facial Papulopustular Rosacea
Interventions
DRUG

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.

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.

Trial Locations (54)

10075

Foamix Investigational Site # 136, New York

10155

Foamix Investigational Site #145, New York

11790

Foamix Investigational Site # 111, Stony Brook

15241

Foamix Investigational Site #157, Saint Clair

19008

Foamix Investigational Site #147, Broomall

19046

Foamix Investigational Site # 141, Jenkintown

19067

Foamix Investigational Site # 129, Yardley

28277

Foamix Investigational Site # 119, Charlotte

29607

Foamix Investigational Site # 106, Greenville

30022

Foamix Investigational Site # 118, Alpharetta

30078

Foamix Investigational Site # 139, Snellville

32174

Foamix Investigational Site # 104, Ormond Beach

32771

Foamix Investigational Site # 121, Sanford

33016

Foamix Investigational Site # 112, Hialeah

Foamix Investigational Site #144, Miami Lakes

33126

Foamix Investigational Site #149, Miami

33144

Foamix Investigational Site #151, Miami

33172

Foamix Investigational Site #154, Sweetwater

33406

Foamix Investigational Site # 142, West Palm Beach

33409

Foamix Investigational Site # 124, West Palm Beach

33467

Foamix Investigational Site #150, Lake Worth

33609

Foamix Investigational Site # 125, Tampa

33757

Foamix Investigational Site # 109, Clearwater

37130

Foamix Investigational Site # 122, Murfreesboro

43016

Foamix Investigational Site # 128, Dublin

43209

Foamix Investigational Site # 101, Bexley

47150

Foamix Investigational Site # 138, New Albany

48059

Foamix Investigational Site # 103, Fort Gratiot

48084

Foamix Investigational Site # 120, Troy

48088

Foamix Investigational Site # 140, Warren

48103

Foamix Investigational Site # 137, Ann Arbor

64506

Foamix Investigational Site # 130, Saint Joseph

68144

Foamix Investigational Site # 133, Omaha

70006

Foamix Investigational Site # 102, Metairie

70115

Foamix Investigational Site # 115, New Orleans

77074

Foamix Investigational Site #159, Houston

78213

Foamix Investigational Site # 108, San Antonio

78759

Foamix Investigational Site # 117, Austin

84117

Foamix Investigational Site # 126, Salt Lake City

85712

Foamix Investigational Site #152, Tucson

89148

Foamix Investigational Site #146, Las Vegas

90036

Foamix Investigational Site #155, Los Angeles

90403

Foamix Investigational Site # 123, Santa Monica

91324

Foamix Investigational Site #143, Northridge

92056

Foamix Investigational Site # 131, Oceanside

Foamix Investigational Site #156, Oceanside

92103

Foamix Investigational Site #153, San Diego

92123

Foamix Investigational Site # 114, San Diego

92705

Foamix Investigational Site # 135, Santa Ana

93405

Foamix Investigational Site # 116, San Luis Obispo

94538

Foamix Investigational Site # 127, Fremont

01915

Foamix Investigational Site # 110, Beverly

02135

Foamix Investigational Site # 107, Brighton

02919

Foamix Investigational Site # 105, Johnston

Sponsors
All Listed Sponsors
collaborator

Premier Research Group plc

UNKNOWN

lead

Vyne Therapeutics Inc.

INDUSTRY

NCT03142451 - A Study (Study 1) to Evaluate the Safety and Efficacy of FMX103 1.5% Topical Minocycline Foam in the Treatment of Facial Papulopustular Rosacea | Biotech Hunter | Biotech Hunter