Clinical trial NCT04608500: A Study (Study 2) 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 (FX2016-12)
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: 2020-10-29
Enrollment: 771
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: Glendale
country: United States
facility: Foamix Investigational Site # 207
state: Arizona
city: Hot Springs
country: United States
facility: Foamix Investigational Site # 202
state: Arkansas
city: Rogers
country: United States
facility: Foamix Investigational Site # 222
state: Arkansas
city: Encino
country: United States
facility: Foamix Investigational Site #244
state: California
city: Huntington Beach
country: United States
facility: Foamix Investigational Site #249
state: California
city: Los Angeles
country: United States
facility: Foamix Investigational Site # 226
state: California
city: Murrieta
country: United States
facility: Foamix Investigational Site # 220
state: California
city: North Hollywood
country: United States
facility: Foamix Investigational Site #251
state: California
city: San Diego
country: United States
facility: Foamix Investigational Site # 217
state: California
city: San Marcos
country: United States
facility: Foamix Investigational Site #250
state: California
city: Temecula
country: United States
facility: Foamix Investigational Site # 239
state: California
city: Denver
country: United States
facility: Foamix Investigational Site # 227
state: Colorado
city: Boca Raton
country: United States
facility: Foamix Investigational Site # 223
state: Florida
city: Boynton Beach
country: United States
facility: Foamix Investigational Site # 215
state: Florida
city: DeLand
country: United States
facility: Foamix Investigational Site #245
state: Florida
city: Fort Myers
country: United States
facility: Foamix Investigational Site # 240
state: Florida
city: Hialeah
country: United States
facility: Foamix Investigational Site #247
state: Florida
city: Hialeah
country: United States
facility: Foamix Investigational Site #252
state: Florida
city: Miami
country: United States
facility: Foamix Investigational Site # 214
state: Florida
city: Miami
country: United States
facility: Foamix Investigational Site #246
state: Florida
city: North Miami Beach
country: United States
facility: Foamix Investigational Site # 241
state: Florida
city: Oldsmar
country: United States
facility: Foamix Investigational Site #248
state: Florida
city: Newnan
country: United States
facility: Foamix Investigational Site # 204
state: Georgia
city: Arlington Heights
country: United States
facility: Foamix Investigational Site # 211
state: Illinois
city: Newburgh
country: United States
facility: Foamix Investigational Site # 225
state: Indiana
city: Plainfield
country: United States
facility: Foamix Investigational Site #243
state: Indiana
city: South Bend
country: United States
facility: Foamix Investigational Site # 218
state: Indiana
city: Louisville
country: United States
facility: Foamix Investigational Site # 235
state: Kentucky
city: Louisville
country: United States
facility: Foamix Investigational Site # 237
state: Kentucky
city: Watertown
country: United States
facility: Foamix Investigational Site # 229
state: Massachusetts
city: Detroit
country: United States
facility: Foamix Investigational Site # 210
state: Michigan
city: Fridley
country: United States
facility: Foamix Investigational Site # 232
state: Minnesota
city: High Point
country: United States
facility: Foamix Investigational Site # 238
state: North Carolina
city: Raleigh
country: United States
facility: Foamix Investigational Site # 212
state: North Carolina
city: Norman
country: United States
facility: Foamix Investigational Site # 236
state: Oklahoma
city: Exton
country: United States
facility: Foamix Investigational Site # 224
state: Pennsylvania
city: Mount Pleasant
country: United States
facility: Foamix Investigational Site # 230
state: South Carolina
city: Knoxville
country: United States
facility: Foamix Investigational Site # 228
state: Tennessee
city: Arlington
country: United States
facility: Foamix Investigational Site # 219
state: Texas
city: Houston
country: United States
facility: Foamix Investigational Site # 201
state: Texas
city: Pflugerville
country: United States
facility: Foamix Investigational Site # 206
state: Texas
city: San Antonio
country: United States
facility: Foamix Investigational Site # 208
state: Texas
city: San Antonio
country: United States
facility: Foamix Investigational Site # 213
state: Texas
city: Webster
country: United States
facility: Foamix Investigational Site # 209
state: Texas
city: Lynchburg
country: United States
facility: Foamix Investigational Site # 216
state: Virginia
city: Seattle
country: United States
facility: Foamix Investigational Site # 203
state: Washington
Study officials:
References: