A Study to Evaluate the Long-Term Safety of Topical Administration of FMX103 in the Treatment of Moderate to Severe Papulopustular Rosacea

Papulopustular Rosacea Clinical Trial

Official title:

An Open-Label Study to Evaluate the Long-Term Safety of Topical Administration of FMX103 for 40 Weeks in the Treatment of Moderate to Severe Facial Papulopustular Rosacea (Study FX2016-13)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03276936
• Other study ID #: FX2016-13
• Status: Completed
• Phase: Phase 3
• Start date: September 5, 2017
• Est. completion date: January 15, 2019

Study information

• Verified date: January 2022
• Source: Vyne Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective is to show that open-label extended treatment with FMX103 1.5%, for up to an additional 40 weeks, is safe and well tolerated.

Description:

This is an open-label, multicenter, 40-week extension study to evaluate the long-term safety, tolerability, and efficacy of FMX103 1.5% topical foam in the treatment of moderate-to-severe facial papulopustular rosacea. Subjects entering this study will have recently participated in 1 of 2 pivotal, double-blind, vehicle-controlled, safety and efficacy studies (FX2016-11 and FX2016-12 - NCT03142451). Subjects must demonstrate that they are eligible to continue into Study FX2016-13 based on safety evaluations and IGA score performed at Final Visit of one of the previous double-blind studies.

At the completion of the Final Visit in Study FX2016-11 or Study FX2016-12, subjects may be invited to continue into this open-label study for an additional 40 weeks of open-label treatment. A minimum of 400 subjects will be enrolled into from Studies FX2016-11 and FX2016-12. Subjects who elect to continue into this open-label study will receive supplies of active FMX103 1.5% minocycline foam.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 504
• Est. completion date: January 15, 2019
• Est. primary completion date: January 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Have completed 12 weeks of treatment in either Study FX2016-11 or Study FX2016-12.

2. Have not had a worsening of disease, determined by the Investigator's Global Assessment (IGA), at Visit 5/Week 12 (Final Visit) relative to the Day 0/Baseline assessment in Study FX2016-11 or Study FX2016-12.

Exclusion Criteria:

1. Have a new systemic disease or condition, including an ongoing AE that might interfere with the conduct of the study or the interpretation of results.

2. Have developed a condition that would have been exclusionary for Study FX2016-11 or Study FX2016-12, including pseudomembranous colitis, antibiotic associated colitis, hepatitis, liver damage, renal impairment, drug addiction, or alcohol abuse.

Related Conditions & MeSH terms

• Papulopustular Rosacea
• Rosacea

Intervention

Drug:
• FMX103 1.5%
FMX103 1.5% minocycline foam

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 # 219	Arlington	Texas
United States	Foamix Investigational Site # 211	Arlington Heights	Illinois
United States	Foamix Investigational Site # 117	Austin	Texas
United States	Foamix Investigational Site # 132	Austin	Texas
United States	Foamix Investigational Site # 242	Bay City	Michigan
United States	Foamix Investigational Site # 110	Beverly	Massachusetts
United States	Foamix Investigational Site # 101	Bexley	Ohio
United States	Foamix Investigational Site # 223	Boca Raton	Florida
United States	Foamix Investigational Site # 215	Boynton Beach	Florida
United States	Foamix Investigational Site # 107	Brighton	Massachusetts
United States	Foamix Investigational Site # 231	Charleston	South Carolina
United States	Foamix Investigational Site # 119	Charlotte	North Carolina
United States	Foamix Investigational Site # 109	Clearwater	Florida
United States	Foamix Investigational Site # 227	Denver	Colorado
United States	Foamix Investigational Site # 210	Detroit	Michigan
United States	Foamix Investigational Site # 128	Dublin	Ohio
United States	Foamix Investigational Site # 224	Exton	Pennsylvania
United States	Foamix Investigational Site # 103	Fort Gratiot	Michigan
United States	Foamix Investigational Site # 240	Fort Myers	Florida
United States	Foamix Investigational Site # 127	Fremont	California
United States	Foamix Investigational Site # 232	Fridley	Minnesota
United States	Foamix Investigational Site # 207	Glendale	Arizona
United States	Foamix Investigational Site # 106	Greenville	South Carolina
United States	Foamix Investigational Site # 112	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 # 141	Jenkintown	Pennsylvania
United States	Foamix Investigational Site # 105	Johnston	Rhode Island
United States	Foamix Investigational Site # 228	Knoxville	Tennessee
United States	Foamix Investigational Site # 221	Las Vegas	Nevada
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 # 102	Metairie	Louisiana
United States	Foamix Investigational Site # 214	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 # 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 # 225	Newburgh	Indiana
United States	Foamix Investigational Site # 204	Newnan	Georgia
United States	Foamix Investigational Site # 236	Norman	Oklahoma
United States	Foamix Investigational Site # 241	North Miami Beach	Florida
United States	Foamix Investigational Site # 131	Oceanside	California
United States	Foamix Investigational Site # 133	Omaha	Nebraska
United States	Foamix Investigational Site # 104	Ormond Beach	Florida
United States	Foamix Investigational Site # 206	Pflugerville	Texas
United States	Foamix Investigational Site # 212	Raleigh	North Carolina
United States	Foamix Investigational Site # 222	Rogers	Arkansas
United States	Foamix Investigational Site # 134	Sacramento	California
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 # 208	San Antonio	Texas
United States	Foamix Investigational Site # 213	San Antonio	Texas
United States	Foamix Investigational Site # 114	San Diego	California
United States	Foamix Investigational Site # 116	San Luis Obispo	California
United States	Foamix Investigational Site # 233	Sandy Springs	Georgia
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 # 203	Seattle	Washington
United States	Foamix Investigational Site # 139	Snellville	Georgia
United States	Foamix Investigational Site # 218	South Bend	Indiana
United States	Foamix Investigational Site # 111	Stony Brook	New York
United States	Foamix Investigational Site # 125	Tampa	Florida
United States	Foamix Investigational Site # 239	Temecula	California
United States	Foamix Investigational Site # 120	Troy	Michigan
United States	Foamix Investigational Site # 140	Warren	Michigan
United States	Foamix Investigational Site # 229	Watertown	Massachusetts
United States	Foamix Investigational Site # 209	Webster	Texas
United States	Foamix Investigational Site # 124	West Palm Beach	Florida
United States	Foamix Investigational Site # 234	Winston-Salem	North Carolina
United States	Foamix Investigational Site # 129	Yardley	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Vyne Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute Change From Baseline in Inflammatory Lesion Count at Week 40	Change from Baseline (Baseline visit in the initial DB study [FX2016-11 or FX2016-12] and Baseline visit of the open-label extension study [Week 12]) in inflammatory lesion count at Week 40 is reported. The lesion counts performed at Week 12 [Final Visit] in Study FX2016-11 or Study FX2016-12 constituted as the Baseline value for this study. Changes from Baseline were calculated as the Baseline [pre-dose] value minus the post-Baseline value, so that decreases reflected a reduction in lesion count. The number of papules, pustules, and nodules were counted, and the numbers recorded.	Day 0/ Baseline (Final visit of previous DB study [Week 12]) and at Week 40
Primary	Percentage of Participants Achieving Investigator's Global Assessments (IGA) Treatment Success at Week 40	The IGA scale for Rosacea, was used by the Investigators to assess the severity of a participant's Rosacea. 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 (score of clear) or 1 (almost clear), and at least a 2-grade improvement (decrease) from Baseline.	At Week 40
Secondary	Absolute Change From Baseline in Inflammatory Lesion Count at Weeks 4, 10, 16, 22, 28, and 34	Change from Baseline (Baseline visit in the initial DB study [FX2016-11 or FX2016-12] and Baseline visit of the open-label extension study [Week 12]) in inflammatory lesion count at Week 40 is reported. The lesion counts performed at Week 12 [Final Visit] in Study FX2016-11 or Study FX2016-12 constituted as the Baseline value for this study. Changes from Baseline were calculated as the Baseline [pre-dose] value minus the post-Baseline value, so that decreases reflected a reduction in lesion count. The number of papules, pustules, and nodules were counted, and the numbers recorded.	Day 0/ Baseline (Final visit of previous DB study [Week 12]) and at Weeks 4, 10, 16, 22, 28, and 34
Secondary	Percentage of Participants Achieving IGA Treatment Success at Weeks 4, 10, 16, 22, 28 and 34	The IGA scale for Rosacea, was used by the Investigators to assess the severity of a participant's Rosacea. 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 (score of clear) or 1 (almost clear), and at least a 2-grade improvement (decrease) from Baseline.	At Weeks 4, 10, 16, 22, 28 and Week 34
Secondary	Percentage Change From Baseline in Inflammatory Lesion Count at Weeks 4, 10, 16, 22, 28, and 34	Change from Baseline (Baseline visit in the initial DB study [FX2016-11 or FX2016-12] and Baseline visit of the open-label extension study [Week 12]) in inflammatory lesion count at Week 40 is reported. The lesion counts performed at Week 12 [Final Visit] in Study FX2016-11 or Study FX2016-12 constituted as the Baseline value for this study. Changes from Baseline were calculated as the Baseline [pre-dose] value minus the post-Baseline value, so that decreases reflected a reduction in lesion count. The number of papules, pustules, and nodules were counted, and the numbers recorded.	Day 0/ Baseline (Final visit of previous DB study [Week 12]) and at Weeks 4, 10, 16, 22, 28, and 34
Secondary	Number of Participants Reporting Satisfaction and Dissatisfaction With the Study Drug Based on Subject Satisfaction Questionnaire (SSQ) at Week 40	The questionnaire consisted of questions with responses on scale with scores: as 1 (Very satisfied or Very likely ) to 5 (Very dissatisfied or Very unlikely) for each variable as for example, Easy to use, 1 is very satisfied and 5 is very dissatisfied. The minimum score represented best outcome and higher score represented worst outcome.	At Week 40
Secondary	Number of Participants With Adverse Events (AEs)	Evaluation of the long-term safety of topical FMX103 1.5% minocycline foam in the treatment of moderate to severe facial papulopustular rosacea for 40 weeks. A Treatment-emergent Adverse Events (TEAEs) was defined as any AE with an onset date after the first dose date of the open-label extension study and before the last application of study drug plus 3 days having been absent pre-treatment or worsened relative to the pre-treatment state.	Day 0/ Baseline (Final visit of previous DB study [Week 12]) until safety follow-up (Week 44)