A Study (Study 2) 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 (FX2016-12)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04608500
• Other study ID #: FX2016-12
• Status: Completed
• Phase: Phase 3
• Start date: June 1, 2017
• Est. completion date: July 31, 2018

Study information

• Verified date: December 2020
• 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: 771
• Est. completion date: July 31, 2018
• Est. primary completion date: July 2, 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 # 219	Arlington	Texas
United States	Foamix Investigational Site # 211	Arlington Heights	Illinois
United States	Foamix Investigational Site # 223	Boca Raton	Florida
United States	Foamix Investigational Site # 215	Boynton Beach	Florida
United States	Foamix Investigational Site #245	DeLand	Florida
United States	Foamix Investigational Site # 227	Denver	Colorado
United States	Foamix Investigational Site # 210	Detroit	Michigan
United States	Foamix Investigational Site #244	Encino	California
United States	Foamix Investigational Site # 224	Exton	Pennsylvania
United States	Foamix Investigational Site # 240	Fort Myers	Florida
United States	Foamix Investigational Site # 232	Fridley	Minnesota
United States	Foamix Investigational Site # 207	Glendale	Arizona
United States	Foamix Investigational Site #247	Hialeah	Florida
United States	Foamix Investigational Site #252	Hialeah	Florida
United States	Foamix Investigational Site # 238	High Point	North Carolina
United States	Foamix Investigational Site # 202	Hot Springs	Arkansas
United States	Foamix Investigational Site # 201	Houston	Texas
United States	Foamix Investigational Site #249	Huntington Beach	California
United States	Foamix Investigational Site # 228	Knoxville	Tennessee
United States	Foamix Investigational Site # 226	Los Angeles	California
United States	Foamix Investigational Site # 235	Louisville	Kentucky
United States	Foamix Investigational Site # 237	Louisville	Kentucky
United States	Foamix Investigational Site # 216	Lynchburg	Virginia
United States	Foamix Investigational Site # 214	Miami	Florida
United States	Foamix Investigational Site #246	Miami	Florida
United States	Foamix Investigational Site # 230	Mount Pleasant	South Carolina
United States	Foamix Investigational Site # 220	Murrieta	California
United States	Foamix Investigational Site # 225	Newburgh	Indiana
United States	Foamix Investigational Site # 204	Newnan	Georgia
United States	Foamix Investigational Site # 236	Norman	Oklahoma
United States	Foamix Investigational Site #251	North Hollywood	California
United States	Foamix Investigational Site # 241	North Miami Beach	Florida
United States	Foamix Investigational Site #248	Oldsmar	Florida
United States	Foamix Investigational Site # 206	Pflugerville	Texas
United States	Foamix Investigational Site #243	Plainfield	Indiana
United States	Foamix Investigational Site # 212	Raleigh	North Carolina
United States	Foamix Investigational Site # 222	Rogers	Arkansas
United States	Foamix Investigational Site # 208	San Antonio	Texas
United States	Foamix Investigational Site # 213	San Antonio	Texas
United States	Foamix Investigational Site # 217	San Diego	California
United States	Foamix Investigational Site #250	San Marcos	California
United States	Foamix Investigational Site # 203	Seattle	Washington
United States	Foamix Investigational Site # 218	South Bend	Indiana
United States	Foamix Investigational Site # 239	Temecula	California
United States	Foamix Investigational Site # 229	Watertown	Massachusetts
United States	Foamix Investigational Site # 209	Webster	Texas

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.	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.	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. 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])