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

Facial Papulopustular Rosacea Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03142451
• Other study ID #: FX2016-11
• Status: Completed
• Phase: Phase 3
• Start date: June 2, 2017
• Est. completion date: September 28, 2018

Study information

• Verified date: January 2021
• Source: Foamix Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 751
• Est. completion date: September 28, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Facial Papulopustular Rosacea
• Facies
• Rosacea

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Foamix Investigational Site # 118	Alpharetta	Georgia
United States	Foamix Investigational Site # 137	Ann Arbor	Michigan
United States	Foamix Investigational Site # 117	Austin	Texas
United States	Foamix Investigational Site # 110	Beverly	Massachusetts
United States	Foamix Investigational Site # 101	Bexley	Ohio
United States	Foamix Investigational Site # 107	Brighton	Massachusetts
United States	Foamix Investigational Site #147	Broomall	Pennsylvania
United States	Foamix Investigational Site # 119	Charlotte	North Carolina
United States	Foamix Investigational Site # 109	Clearwater	Florida
United States	Foamix Investigational Site # 128	Dublin	Ohio
United States	Foamix Investigational Site # 103	Fort Gratiot	Michigan
United States	Foamix Investigational Site # 127	Fremont	California
United States	Foamix Investigational Site # 106	Greenville	South Carolina
United States	Foamix Investigational Site # 112	Hialeah	Florida
United States	Foamix Investigational Site #159	Houston	Texas
United States	Foamix Investigational Site # 141	Jenkintown	Pennsylvania
United States	Foamix Investigational Site # 105	Johnston	Rhode Island
United States	Foamix Investigational Site #150	Lake Worth	Florida
United States	Foamix Investigational Site #146	Las Vegas	Nevada
United States	Foamix Investigational Site #155	Los Angeles	California
United States	Foamix Investigational Site # 102	Metairie	Louisiana
United States	Foamix Investigational Site #149	Miami	Florida
United States	Foamix Investigational Site #151	Miami	Florida
United States	Foamix Investigational Site #144	Miami Lakes	Florida
United States	Foamix Investigational Site # 122	Murfreesboro	Tennessee
United States	Foamix Investigational Site # 138	New Albany	Indiana
United States	Foamix Investigational Site # 115	New Orleans	Louisiana
United States	Foamix Investigational Site # 136	New York	New York
United States	Foamix Investigational Site #145	New York	New York
United States	Foamix Investigational Site #143	Northridge	California
United States	Foamix Investigational Site # 131	Oceanside	California
United States	Foamix Investigational Site #156	Oceanside	California
United States	Foamix Investigational Site # 133	Omaha	Nebraska
United States	Foamix Investigational Site # 104	Ormond Beach	Florida
United States	Foamix Investigational Site #157	Saint Clair	Pennsylvania
United States	Foamix Investigational Site # 130	Saint Joseph	Missouri
United States	Foamix Investigational Site # 126	Salt Lake City	Utah
United States	Foamix Investigational Site # 108	San Antonio	Texas
United States	Foamix Investigational Site # 114	San Diego	California
United States	Foamix Investigational Site #153	San Diego	California
United States	Foamix Investigational Site # 116	San Luis Obispo	California
United States	Foamix Investigational Site # 121	Sanford	Florida
United States	Foamix Investigational Site # 135	Santa Ana	California
United States	Foamix Investigational Site # 123	Santa Monica	California
United States	Foamix Investigational Site # 139	Snellville	Georgia
United States	Foamix Investigational Site # 111	Stony Brook	New York
United States	Foamix Investigational Site #154	Sweetwater	Florida
United States	Foamix Investigational Site # 125	Tampa	Florida
United States	Foamix Investigational Site # 120	Troy	Michigan
United States	Foamix Investigational Site #152	Tucson	Arizona
United States	Foamix Investigational Site # 140	Warren	Michigan
United States	Foamix Investigational Site # 124	West Palm Beach	Florida
United States	Foamix Investigational Site # 142	West Palm Beach	Florida
United States	Foamix Investigational Site # 129	Yardley	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Foamix Ltd.	Premier Research Group plc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Absolute Change From Day 0/Baseline in the Inflammatory Lesion Count at Week 12	To determine the efficacy of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea. Lesion counts included the number of papules, pustules, and nodules.; Change from Baseline was calculated as the value at Baseline minus the post-Baseline value. Thus, a positive change reflects a reduction in lesion count.	Baseline and Week 12
Primary	Percentage of Participants Achieving Investigator Global Assessments (IGA) Treatment Success at Week 12	To determine the efficacy of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea. The Investigator assessed the global severity of rosacea using the IGA scale. The scale ranges from 0 (Clear): No inflammatory papules or pustules to 4 (Severe): Many inflammatory papules or pustules, and up to 2 nodules. Higher scores indicated severe outcome. Treatment success was defined as an IGA score of 0 (clear) or 1 (almost clear), and at least a 2-step improvement (decrease) from Day 0/Baseline.	Week 12
Secondary	Percentage of Participants Achieving IGA Treatment Success of at Least 2 Grades at Week 12	To determine the efficacy of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea. The Investigator assessed the global severity of rosacea using the IGA scale. The scale ranges from 0 (Clear): No inflammatory papules or pustules to 4 (Severe): Many inflammatory papules or pustules, and up to 2 nodules. Higher scores indicated severe outcome. Treatment success was defined as a 2-grade improvement (decrease) in score at Week 12 compared to Day 0/Baseline.; Here, overall number of participants analyzed signifies only the participants with available data that were analyzed for the outcome measure.	Week 12
Secondary	The Percent Change From Day 0/Baseline in Inflammatory Lesion Count at Week 12	To determine the efficacy of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea. Lesion counts included the number of papules, pustules, and nodules.; Here, overall number of participants analyzed signifies only the participants with available data that were analyzed for the outcome measure.	Baseline and Week 12
Secondary	The Absolute Change From Day 0/Baseline in the Inflammatory Lesion Counts at Week 4 and Week 8	To determine the efficacy of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea. Lesion counts included the number of papules, pustules, and nodules. The change from Baseline was calculated as the value at Baseline minus the post-Baseline value. Thus, a positive change reflects a reduction in lesion count.	Baseline, Week 4 and Week 8
Secondary	Percentage of Participants Achieving IGA Treatment Success at Week 4 and Week 8	To determine the efficacy of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea. The Investigator assessed the global severity of rosacea using the IGA scale. The scale ranges from 0 (Clear): No inflammatory papules or pustules to 4 (Severe): Many inflammatory papules or pustules, and up to 2 nodules. Higher scores indicated severe outcome. Treatment success was defined as an IGA score of 0 (clear) or 1 (almost clear), and at least a 2-grade improvement (decrease) from Day 0/Baseline.	Week 4 and Week 8
Secondary	Number of Participants With Adverse Events (AEs)	To evaluate the tolerability and safety of topical minocycline foam applied once daily for 12 weeks. A treatment-emergent adverse events (TEAE) was defined as any AE with an onset date on or after the first application of study drug, and before to the last application of study drug plus 3 days, having been absent pre-treatment or worsening relative to the pre-treatment state.	From Day 0/Baseline until the Safety Follow-up (4 weeks after Week 12 [Final Visit])