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

PHASE3CompletedINTERVENTIONAL
Enrollment

771

Participants

Timeline

Start Date

June 1, 2017

Primary Completion Date

July 2, 2018

Study Completion Date

July 31, 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 (46)

19341

Foamix Investigational Site # 224, Exton

24501

Foamix Investigational Site # 216, Lynchburg

27262

Foamix Investigational Site # 238, High Point

27612

Foamix Investigational Site # 212, Raleigh

29464

Foamix Investigational Site # 230, Mt. Pleasant

32720

Foamix Investigational Site #245, DeLand

33015

Foamix Investigational Site #247, Hialeah

33106

Foamix Investigational Site #252, Hialeah

33126

Foamix Investigational Site # 214, Miami

33162

Foamix Investigational Site # 241, North Miami Beach

33186

Foamix Investigational Site #246, Miami

33437

Foamix Investigational Site # 215, Boynton Beach

33486

Foamix Investigational Site # 223, Boca Raton

33912

Foamix Investigational Site # 240, Fort Myers

34677

Foamix Investigational Site #248, Oldsmar

37922

Foamix Investigational Site # 228, Knoxville

40217

Foamix Investigational Site # 235, Louisville

40241

Foamix Investigational Site # 237, Louisville

46168

Foamix Investigational Site #243, Plainfield

46617

Foamix Investigational Site # 218, South Bend

47630

Foamix Investigational Site # 225, Newburgh

48202

Foamix Investigational Site # 210, Detroit

55432

Foamix Investigational Site # 232, Fridley

60005

Foamix Investigational Site # 211, Arlington Heights

71913

Foamix Investigational Site # 202, Hot Springs

72758

Foamix Investigational Site # 222, Rogers

73071

Foamix Investigational Site # 236, Norman

76011

Foamix Investigational Site # 219, Arlington

77004

Foamix Investigational Site # 201, Houston

77598

Foamix Investigational Site # 209, Webster

78229

Foamix Investigational Site # 208, San Antonio

Foamix Investigational Site # 213, San Antonio

78660

Foamix Investigational Site # 204, Newnan

Foamix Investigational Site # 206, Pflugerville

80209

Foamix Investigational Site # 227, Denver

85308

Foamix Investigational Site # 207, Glendale

90045

Foamix Investigational Site # 226, Los Angeles

91436

Foamix Investigational Site #244, Encino

91606

Foamix Investigational Site #251, North Hollywood

92078

Foamix Investigational Site #250, San Marcos

92123

Foamix Investigational Site # 217, San Diego

92562

Foamix Investigational Site # 220, Murrieta

92592

Foamix Investigational Site # 239, Temecula

92647

Foamix Investigational Site #249, Huntington Beach

98104

Foamix Investigational Site # 203, Seattle

02472

Foamix Investigational Site # 229, Watertown

Sponsors
All Listed Sponsors
collaborator

Premier Research Group plc

UNKNOWN

lead

Vyne Therapeutics Inc.

INDUSTRY