Clinical trial 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
Official title: A Randomized, Multicenter, Double-blind, Vehicle-controlled Study to Evaluate the Safety and Efficacy of FMX103 1.5% Topical Minocycline Foam Compared to Vehicle in the Treatment of Facial Papulopustular Rosacea (FX2016-11)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Facial Papulopustular Rosacea
Keywords: Topical Minocycline Foam
2-Arm study
Inflammatory lesion counts
Investigator's Global Assessment score
Lead sponsor: Vyne Therapeutics Inc.
Sponsor class: INDUSTRY
Collaborators: name: Premier Research Group plc
First posted: 2017-05-05
Enrollment: 751
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: This is a randomized, multicenter, double-blind, vehicle-controlled, 2 arm study to evaluate the safety and efficacy of FMX103 topical foam containing 1.5% minocycline compared to vehicle, in the treatment of participants with moderate-to-severe facial papulopustular rosacea. Qualified participants will be randomized in a 2:1 ratio (active:vehicle) to receive 1 of the following 2 treatments:

* FMX103 minocycline foam 1.5%
* Vehicle foam

Participants will be assigned to 1 of 2 treatments according to the randomization schedule. Participants will apply (or have applied) the study drug topically once daily for 12 weeks as directed. Participants will be advised to use the study drug at approximately the same time each day. Both the Investigator and participant will be blinded to the study drug identity. Participants will return for visits at Weeks 1, 4, 6, 8, 10, and 12. Efficacy evaluations (inflammatory lesion counts and Investigator's Global Assessment \[IGA\] score) will be performed at Weeks 4, 8, and 12 during the study.

Note: Originally the two studies FX2016-11 and FX2016-12 were combinedly presented in the protocol registration form under one NCT number (NCT03142451), and later separated since results were analyzed separately.

Eligibility criteria: Inclusion Criteria:

1. Moderate-to-severe rosacea (as per the IGA score) on the proposed facial treatment area consisting of:

   1. At least 15 and not more than 75 facial papules and pustules, excluding lesions involving the eyes and scalp;
   2. No more than 2 nodules on the face.
2. Presence of or history of erythema and/or flushing on the face.

Exclusion Criteria:

1. Presence of any skin condition and/or Excessive facial hair, on the face that would interfere with the diagnosis or assessment of rosacea.
2. Moderate or severe rhinophyma, dense telangiectasia (score 3, severe), or plaque-like facial edema.
3. History of hypersensitivity or allergy to minocycline, any other tetracycline, or of any other component of the formulation.
4. Active ocular rosacea (eg, conjunctivitis, blepharitis, or keratitis) of sufficient severity to require topical or systemic antibiotics.

Primary outcomes:
measure: The Absolute Change From Day 0/Baseline in the Inflammatory Lesion Count at Week 12
timeFrame: Baseline and Week 12
measure: Percentage of Participants Achieving Investigator Global Assessments (IGA) Treatment Success at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Percentage of Participants Achieving IGA Treatment Success of at Least 2 Grades at Week 12
timeFrame: Week 12
measure: The Percent Change From Day 0/Baseline in Inflammatory Lesion Count at Week 12
timeFrame: Baseline and Week 12
measure: The Absolute Change From Day 0/Baseline in the Inflammatory Lesion Counts at Week 4 and Week 8
timeFrame: Baseline, Week 4 and Week 8
measure: Percentage of Participants Achieving IGA Treatment Success at Week 4 and Week 8
timeFrame: Week 4 and Week 8
measure: Number of Participants With Adverse Events (AEs)
timeFrame: From Day 0/Baseline until the Safety Follow-up (4 weeks after Week 12 [Final Visit])
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Foamix Investigational Site #152
state: Arizona
city: Fremont
country: United States
facility: Foamix Investigational Site # 127
state: California
city: Los Angeles
country: United States
facility: Foamix Investigational Site #155
state: California
city: Northridge
country: United States
facility: Foamix Investigational Site #143
state: California
city: Oceanside
country: United States
facility: Foamix Investigational Site # 131
state: California
city: Oceanside
country: United States
facility: Foamix Investigational Site #156
state: California
city: San Diego
country: United States
facility: Foamix Investigational Site #153
state: California
city: San Diego
country: United States
facility: Foamix Investigational Site # 114
state: California
city: San Luis Obispo
country: United States
facility: Foamix Investigational Site # 116
state: California
city: Santa Ana
country: United States
facility: Foamix Investigational Site # 135
state: California
city: Santa Monica
country: United States
facility: Foamix Investigational Site # 123
state: California
city: Clearwater
country: United States
facility: Foamix Investigational Site # 109
state: Florida
city: Hialeah
country: United States
facility: Foamix Investigational Site # 112
state: Florida
city: Lake Worth
country: United States
facility: Foamix Investigational Site #150
state: Florida
city: Miami Lakes
country: United States
facility: Foamix Investigational Site #144
state: Florida
city: Miami
country: United States
facility: Foamix Investigational Site #149
state: Florida
city: Miami
country: United States
facility: Foamix Investigational Site #151
state: Florida
city: Ormond Beach
country: United States
facility: Foamix Investigational Site # 104
state: Florida
city: Sanford
country: United States
facility: Foamix Investigational Site # 121
state: Florida
city: Sweetwater
country: United States
facility: Foamix Investigational Site #154
state: Florida
city: Tampa
country: United States
facility: Foamix Investigational Site # 125
state: Florida
city: West Palm Beach
country: United States
facility: Foamix Investigational Site # 142
state: Florida
city: West Palm Beach
country: United States
facility: Foamix Investigational Site # 124
state: Florida
city: Alpharetta
country: United States
facility: Foamix Investigational Site # 118
state: Georgia
city: Snellville
country: United States
facility: Foamix Investigational Site # 139
state: Georgia
city: New Albany
country: United States
facility: Foamix Investigational Site # 138
state: Indiana
city: Metairie
country: United States
facility: Foamix Investigational Site # 102
state: Louisiana
city: New Orleans
country: United States
facility: Foamix Investigational Site # 115
state: Louisiana
city: Beverly
country: United States
facility: Foamix Investigational Site # 110
state: Massachusetts
city: Brighton
country: United States
facility: Foamix Investigational Site # 107
state: Massachusetts
city: Ann Arbor
country: United States
facility: Foamix Investigational Site # 137
state: Michigan
city: Fort Gratiot
country: United States
facility: Foamix Investigational Site # 103
state: Michigan
city: Troy
country: United States
facility: Foamix Investigational Site # 120
state: Michigan
city: Warren
country: United States
facility: Foamix Investigational Site # 140
state: Michigan
city: Saint Joseph
country: United States
facility: Foamix Investigational Site # 130
state: Missouri
city: Omaha
country: United States
facility: Foamix Investigational Site # 133
state: Nebraska
city: Las Vegas
country: United States
facility: Foamix Investigational Site #146
state: Nevada
city: New York
country: United States
facility: Foamix Investigational Site # 136
state: New York
city: New York
country: United States
facility: Foamix Investigational Site #145
state: New York
city: Stony Brook
country: United States
facility: Foamix Investigational Site # 111
state: New York
city: Charlotte
country: United States
facility: Foamix Investigational Site # 119
state: North Carolina
city: Bexley
country: United States
facility: Foamix Investigational Site # 101
state: Ohio
city: Dublin
country: United States
facility: Foamix Investigational Site # 128
state: Ohio
city: Broomall
country: United States
facility: Foamix Investigational Site #147
state: Pennsylvania
city: Jenkintown
country: United States
facility: Foamix Investigational Site # 141
state: Pennsylvania
city: Saint Clair
country: United States
facility: Foamix Investigational Site #157
state: Pennsylvania
city: Yardley
country: United States
facility: Foamix Investigational Site # 129
state: Pennsylvania
city: Johnston
country: United States
facility: Foamix Investigational Site # 105
state: Rhode Island
city: Greenville
country: United States
facility: Foamix Investigational Site # 106
state: South Carolina
city: Murfreesboro
country: United States
facility: Foamix Investigational Site # 122
state: Tennessee
city: Austin
country: United States
facility: Foamix Investigational Site # 117
state: Texas
city: Houston
country: United States
facility: Foamix Investigational Site #159
state: Texas
city: San Antonio
country: United States
facility: Foamix Investigational Site # 108
state: Texas
city: Salt Lake City
country: United States
facility: Foamix Investigational Site # 126
state: Utah
Study officials:
References: