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

• Sponsor: Vyne Therapeutics Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03276936
• Collaborator: (none)
• Enrollment: 504
• Locations: 79
• Arm: 1
• Actual Duration (Months): 16.3
• Patients Per Site: 6.4
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Papulopustular Rosacea	Drug: FMX103 1.5%	Phase 3

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 504 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: Sep 5, 2017
• Actual Primary Completion Date: Jan 3, 2019
• Actual Study Completion Date: Jan 15, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Minocycline Foam 1.5% FMX-103	Drug: FMX103 1.5%; FMX103 1.5% minocycline foam

Outcome Measures

Primary Outcome Measures

1. Absolute Change From Baseline in Inflammatory Lesion Count at Week 40 [Day 0/ Baseline (Final visit of previous DB study [Week 12]) and 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.

2. Percentage of Participants Achieving Investigator's Global Assessments (IGA) Treatment Success at Week 40 [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.

Secondary Outcome Measures

1. Absolute Change From Baseline in Inflammatory Lesion Count at Weeks 4, 10, 16, 22, 28, and 34 [Day 0/ Baseline (Final visit of previous DB study [Week 12]) and 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.

2. Percentage of Participants Achieving IGA Treatment Success at Weeks 4, 10, 16, 22, 28 and 34 [At Weeks 4, 10, 16, 22, 28 and Week 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.

3. Percentage Change From Baseline in Inflammatory Lesion Count at Weeks 4, 10, 16, 22, 28, and 34 [Day 0/ Baseline (Final visit of previous DB study [Week 12]) and 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.

4. Number of Participants Reporting Satisfaction and Dissatisfaction With the Study Drug Based on Subject Satisfaction Questionnaire (SSQ) at Week 40 [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.

5. Number of Participants With Adverse Events (AEs) [Day 0/ Baseline (Final visit of previous DB study [Week 12]) until safety follow-up (Week 44)]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Foamix Investigational Site # 207	Glendale	Arizona	United States	85308
2	Foamix Investigational Site # 202	Hot Springs	Arkansas	United States	71913
3	Foamix Investigational Site # 222	Rogers	Arkansas	United States	72758
4	Foamix Investigational Site # 127	Fremont	California	United States	94538
5	Foamix Investigational Site # 226	Los Angeles	California	United States	90045
6	Foamix Investigational Site # 220	Murrieta	California	United States	92562
7	Foamix Investigational Site # 131	Oceanside	California	United States	92056
8	Foamix Investigational Site # 134	Sacramento	California	United States	95819
9	Foamix Investigational Site # 114	San Diego	California	United States	92123
10	Foamix Investigational Site # 116	San Luis Obispo	California	United States	93405
11	Foamix Investigational Site # 135	Santa Ana	California	United States	92705
12	Foamix Investigational Site # 123	Santa Monica	California	United States	90403
13	Foamix Investigational Site # 239	Temecula	California	United States	92592
14	Foamix Investigational Site # 227	Denver	Colorado	United States	80209
15	Foamix Investigational Site # 223	Boca Raton	Florida	United States	33486
16	Foamix Investigational Site # 215	Boynton Beach	Florida	United States	33437
17	Foamix Investigational Site # 109	Clearwater	Florida	United States	33757
18	Foamix Investigational Site # 240	Fort Myers	Florida	United States	33912
19	Foamix Investigational Site # 112	Hialeah	Florida	United States	33016
20	Foamix Investigational Site # 214	Miami	Florida	United States	33126
21	Foamix Investigational Site # 241	North Miami Beach	Florida	United States	33162
22	Foamix Investigational Site # 104	Ormond Beach	Florida	United States	32174
23	Foamix Investigational Site # 121	Sanford	Florida	United States	32771
24	Foamix Investigational Site # 125	Tampa	Florida	United States	33609
25	Foamix Investigational Site # 124	West Palm Beach	Florida	United States	33409
26	Foamix Investigational Site # 118	Alpharetta	Georgia	United States	30022
27	Foamix Investigational Site # 204	Newnan	Georgia	United States	78660
28	Foamix Investigational Site # 233	Sandy Springs	Georgia	United States	30328
29	Foamix Investigational Site # 139	Snellville	Georgia	United States	30078
30	Foamix Investigational Site # 211	Arlington Heights	Illinois	United States	60005
31	Foamix Investigational Site # 138	New Albany	Indiana	United States	47150
32	Foamix Investigational Site # 225	Newburgh	Indiana	United States	47630
33	Foamix Investigational Site # 218	South Bend	Indiana	United States	46617
34	Foamix Investigational Site # 235	Louisville	Kentucky	United States	40217
35	Foamix Investigational Site # 237	Louisville	Kentucky	United States	40241
36	Foamix Investigational Site # 102	Metairie	Louisiana	United States	70006
37	Foamix Investigational Site # 115	New Orleans	Louisiana	United States	70115
38	Foamix Investigational Site # 110	Beverly	Massachusetts	United States	01915
39	Foamix Investigational Site # 107	Brighton	Massachusetts	United States	02135
40	Foamix Investigational Site # 229	Watertown	Massachusetts	United States	02472
41	Foamix Investigational Site # 137	Ann Arbor	Michigan	United States	48103
42	Foamix Investigational Site # 242	Bay City	Michigan	United States	48706
43	Foamix Investigational Site # 210	Detroit	Michigan	United States	48202
44	Foamix Investigational Site # 103	Fort Gratiot	Michigan	United States	48059
45	Foamix Investigational Site # 120	Troy	Michigan	United States	48084
46	Foamix Investigational Site # 140	Warren	Michigan	United States	48088
47	Foamix Investigational Site # 232	Fridley	Minnesota	United States	55432
48	Foamix Investigational Site # 130	Saint Joseph	Missouri	United States	64506
49	Foamix Investigational Site # 133	Omaha	Nebraska	United States	68144
50	Foamix Investigational Site # 221	Las Vegas	Nevada	United States	89128
51	Foamix Investigational Site # 136	New York	New York	United States	10075
52	Foamix Investigational Site # 111	Stony Brook	New York	United States	11790
53	Foamix Investigational Site # 119	Charlotte	North Carolina	United States	28277
54	Foamix Investigational Site # 238	High Point	North Carolina	United States	27262
55	Foamix Investigational Site # 212	Raleigh	North Carolina	United States	27612
56	Foamix Investigational Site # 234	Winston-Salem	North Carolina	United States	27103
57	Foamix Investigational Site # 101	Bexley	Ohio	United States	43209
58	Foamix Investigational Site # 128	Dublin	Ohio	United States	43016
59	Foamix Investigational Site # 236	Norman	Oklahoma	United States	73071
60	Foamix Investigational Site # 224	Exton	Pennsylvania	United States	19341
61	Foamix Investigational Site # 141	Jenkintown	Pennsylvania	United States	19046
62	Foamix Investigational Site # 129	Yardley	Pennsylvania	United States	19067
63	Foamix Investigational Site # 105	Johnston	Rhode Island	United States	02919
64	Foamix Investigational Site # 231	Charleston	South Carolina	United States	29407
65	Foamix Investigational Site # 106	Greenville	South Carolina	United States	29607
66	Foamix Investigational Site # 230	Mount Pleasant	South Carolina	United States	29464
67	Foamix Investigational Site # 228	Knoxville	Tennessee	United States	37922
68	Foamix Investigational Site # 219	Arlington	Texas	United States	76011
69	Foamix Investigational Site # 132	Austin	Texas	United States	78746
70	Foamix Investigational Site # 117	Austin	Texas	United States	78759
71	Foamix Investigational Site # 201	Houston	Texas	United States	77004
72	Foamix Investigational Site # 206	Pflugerville	Texas	United States	78660
73	Foamix Investigational Site # 108	San Antonio	Texas	United States	78213
74	Foamix Investigational Site # 208	San Antonio	Texas	United States	78229
75	Foamix Investigational Site # 213	San Antonio	Texas	United States	78229
76	Foamix Investigational Site # 209	Webster	Texas	United States	77598
77	Foamix Investigational Site # 126	Salt Lake City	Utah	United States	84117
78	Foamix Investigational Site # 216	Lynchburg	Virginia	United States	24501
79	Foamix Investigational Site # 203	Seattle	Washington	United States	98104

Sponsors and Collaborators

• Vyne Therapeutics Inc.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Jun 22, 2017
• Statistical Analysis Plan - Jan 8, 2019

More Information

Publications

None provided.

• Responsible Party: Vyne Therapeutics Inc.
• ClinicalTrials.gov Identifier: NCT03276936
• Other Study ID Numbers: FX2016-13
• First Posted: Sep 8, 2017
• Last Update Posted: Jan 18, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Rosacea

Study Results

Participant Flow

Recruitment Details	This open-label, multi-center, 40-week extension study was conducted at 70 sites in the United States from 05 September 2017 to 03 January 2019, and enrolled participants from previous double-blind (DB) studies FX2016-11 and FX2016-12.
Pre-assignment Detail	Baseline for the study was conducted at the same time as Visit 5/Week 12 (Final Visit) of Study FX2016-11 or Study FX2016-12. All assessments performed at Visit 5/Week 12 (Final Visit) of Study FX2016-11 or Study FX2016-12 were not repeated but rather recorded as the same assessments at Baseline for this study.

Arm/Group Title	DB-FMX103 1.5% Minocycline Foam	DB-Vehicle Foam
Arm/Group Description	Enrolled participants from Study FX2016-11 and Study FX2016-12 (FMX103 1.5% group) applied FMX103 1.5% minocycline foam topically to the face once daily for 40 weeks in this present Study FX2016-13. Participants were grouped based on their experience in the previous double-blind study, and that all participants received the study drug in an open-label fashion.	Enrolled participants from Study FX2016-11 and Study FX2016-12 (FMX103 1.5% group) applied FMX103 1.5% minocycline foam topically to the face once daily for 40 weeks in this present Study FX2016-13. Participants were grouped based on their experience in the previous double-blind study, and that all participants received the study drug in an open-label fashion.
Period Title: Overall Study
STARTED	332	172
COMPLETED	276	134
NOT COMPLETED	56	38

Baseline Characteristics

Arm/Group Title	DB-FMX103 1.5% Minocycline Foam	DB-Vehicle Foam	Total
Arm/Group Description	Enrolled participants from Study FX2016-11 and Study FX2016-12 (FMX103 1.5% group) applied FMX103 1.5% minocycline foam topically to the face once daily for 40 weeks in this present Study FX2016-13. Participants were grouped based on their experience in the previous double-blind study, and that all participants received the study drug in an open-label fashion.	Enrolled participants from Study FX2016-11 and Study FX2016-12 (FMX103 1.5% group) applied FMX103 1.5% minocycline foam topically to the face once daily for 40 weeks in this present Study FX2016-13. Participants were grouped based on their experience in the previous double-blind study, and that all participants received the study drug in an open-label fashion.	Total of all reporting groups
Overall Participants	332	172	504
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	51.1 (12.62)	51.9 (11.90)	51.4 (12.37)
Sex: Female, Male (Count of Participants)
Female	241 72.6%	110 64%	351 69.6%
Male	91 27.4%	62 36%	153 30.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	62 18.7%	31 18%	93 18.5%
Not Hispanic or Latino	269 81%	141 82%	410 81.3%
Unknown or Not Reported	1 0.3%	0 0%	1 0.2%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 0.3%	0 0%	1 0.2%
Asian	3 0.9%	4 2.3%	7 1.4%
Native Hawaiian or Other Pacific Islander	0 0%	1 0.6%	1 0.2%
Black or African American	5 1.5%	3 1.7%	8 1.6%
White	321 96.7%	163 94.8%	484 96%
More than one race	2 0.6%	0 0%	2 0.4%
Unknown or Not Reported	0 0%	1 0.6%	1 0.2%

Outcome Measures

1. Primary Outcome

Title	Absolute Change From Baseline in Inflammatory Lesion Count at Week 40
Description	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.
Time Frame	Day 0/ Baseline (Final visit of previous DB study [Week 12]) and at Week 40

Outcome Measure Data

Analysis Population Description

All treated population included all participants who used the study drug at least once. Here, overall number of participants analyzed (N) signifies only the participants with available data that were analyzed for the outcome measure.

Arm/Group Title	DB-FMX103 1.5% Minocycline Foam	DB-Vehicle Foam
Arm/Group Description	Enrolled participants from Study FX2016-11 and Study FX2016-12 (FMX103 1.5% group) applied FMX103 1.5% minocycline foam topically to the face once daily for 40 weeks in this present Study FX2016-13. Participants were grouped based on their experience in the previous double-blind study, and that all participants received the study drug in an open-label fashion.	Enrolled participants from Study FX2016-11 and Study FX2016-12 (FMX103 1.5% group) applied FMX103 1.5% minocycline foam topically to the face once daily for 40 weeks in this present Study FX2016-13. Participants were grouped based on their experience in the previous double-blind study, and that all participants received the study drug in an open-label fashion.
Measure Participants	272	129
Mean (Standard Deviation) [Lesions]	23.0 (10.96)	22.5 (10.83)

2. Primary Outcome

Title	Percentage of Participants Achieving Investigator's Global Assessments (IGA) Treatment Success at Week 40
Description	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.
Time Frame	At Week 40

Outcome Measure Data

Analysis Population Description

All treated population included all participants who used the study drug at least once. Here, overall number of participants analyzed (N) signifies only the participants with available data that were analyzed for the outcome measure.

Arm/Group Title	DB-FMX103 1.5% Minocycline Foam	DB-Vehicle Foam
Arm/Group Description	Enrolled participants from Study FX2016-11 and Study FX2016-12 (FMX103 1.5% group) applied FMX103 1.5% minocycline foam topically to the face once daily for 40 weeks in this present Study FX2016-13. Participants were grouped based on their experience in the previous double-blind study, and that all participants received the study drug in an open-label fashion.	Enrolled participants from Study FX2016-11 and Study FX2016-12 (FMX103 1.5% group) applied FMX103 1.5% minocycline foam topically to the face once daily for 40 weeks in this present Study FX2016-13. Participants were grouped based on their experience in the previous double-blind study, and that all participants received the study drug in an open-label fashion.
Measure Participants	272	129
Number [Percentage of participants]	81.6 24.6%	76.0 44.2%

3. Secondary Outcome

Title	Absolute Change From Baseline in Inflammatory Lesion Count at Weeks 4, 10, 16, 22, 28, and 34
Description	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.
Time Frame	Day 0/ Baseline (Final visit of previous DB study [Week 12]) and at Weeks 4, 10, 16, 22, 28, and 34

Outcome Measure Data

Analysis Population Description

All treated population included all participants who used the study drug at least once. Here, number analyzed (n) signifies only the participants with available data that were analyzed at given specified week.

Arm/Group Title	DB-FMX103 1.5% Minocycline Foam	DB-Vehicle Foam
Arm/Group Description	Enrolled participants from Study FX2016-11 and Study FX2016-12 (FMX103 1.5% group) applied FMX103 1.5% minocycline foam topically to the face once daily for 40 weeks in this present Study FX2016-13. Participants were grouped based on their experience in the previous double-blind study, and that all participants received the study drug in an open-label fashion.	Enrolled participants from Study FX2016-11 and Study FX2016-12 (FMX103 1.5% group) applied FMX103 1.5% minocycline foam topically to the face once daily for 40 weeks in this present Study FX2016-13. Participants were grouped based on their experience in the previous double-blind study, and that all participants received the study drug in an open-label fashion.
Measure Participants	332	172
Week 4	19.5 (11.57)	17.4 (12.18)
Week 10	20.4 (11.62)	19.8 (12.92)
Week 16	21.9 (11.38)	20.0 (13.09)
Week 22	22.2 (12.35)	20.7 (11.33)
Week 28	22.4 (11.89)	21.7 (10.89)
Week 34	23.2 (11.75)	22.5 (10.71)

4. Secondary Outcome

Title	Percentage of Participants Achieving IGA Treatment Success at Weeks 4, 10, 16, 22, 28 and 34
Description	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.
Time Frame	At Weeks 4, 10, 16, 22, 28 and Week 34

Outcome Measure Data

Analysis Population Description

All treated population included all participants who used the study drug at least once. Here, number analyzed (n) signifies only the participants with available data that were analyzed at given specified week.

Arm/Group Title	DB-FMX103 1.5% Minocycline Foam	DB-Vehicle Foam
Arm/Group Description	Enrolled participants from Study FX2016-11 and Study FX2016-12 (FMX103 1.5% group) applied FMX103 1.5% minocycline foam topically to the face once daily for 40 weeks in this present Study FX2016-13. Participants were grouped based on their experience in the previous double-blind study, and that all participants received the study drug in an open-label fashion.	Enrolled participants from Study FX2016-11 and Study FX2016-12 (FMX103 1.5% group) applied FMX103 1.5% minocycline foam topically to the face once daily for 40 weeks in this present Study FX2016-13. Participants were grouped based on their experience in the previous double-blind study, and that all participants received the study drug in an open-label fashion.
Measure Participants	332	172
Week 4	50.6 15.2%	48.2 28%
Week 10	60.1 18.1%	54.5 31.7%
Week 16	68.1 20.5%	64.0 37.2%
Week 22	69.1 20.8%	64.4 37.4%
Week 28	72.4 21.8%	65.9 38.3%
Week 34	73.5 22.1%	72.1 41.9%

5. Secondary Outcome

Title	Percentage Change From Baseline in Inflammatory Lesion Count at Weeks 4, 10, 16, 22, 28, and 34
Description	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.
Time Frame	Day 0/ Baseline (Final visit of previous DB study [Week 12]) and at Weeks 4, 10, 16, 22, 28, and 34

Outcome Measure Data

Analysis Population Description

All treated population included all participants who used the study drug at least once. Here, number analyzed (n) signifies only the participants with available data that were analyzed at given specified week.

Arm/Group Title	DB-FMX103 1.5% Minocycline Foam	DB-Vehicle Foam
Arm/Group Description	Enrolled participants from Study FX2016-11 and Study FX2016-12 (FMX103 1.5% group) applied FMX103 1.5% minocycline foam topically to the face once daily for 40 weeks in this present Study FX2016-13. Participants were grouped based on their experience in the previous double-blind study, and that all participants received the study drug in an open-label fashion.	Enrolled participants from Study FX2016-11 and Study FX2016-12 (FMX103 1.5% group) applied FMX103 1.5% minocycline foam topically to the face once daily for 40 weeks in this present Study FX2016-13. Participants were grouped based on their experience in the previous double-blind study, and that all participants received the study drug in an open-label fashion.
Measure Participants	332	172
Week 4	67.91 (27.569)	61.25 (32.306)
Week 10	72.43 (27.937)	69.02 (32.966)
Week 16	77.36 (22.739)	71.46 (33.230)
Week 22	77.51 (25.101)	73.63 (27.515)
Week 28	78.82 (23.439)	77.06 (25.863)
Week 34	81.91 (20.549)	80.38 (22.873)

6. Secondary Outcome

Title	Number of Participants Reporting Satisfaction and Dissatisfaction With the Study Drug Based on Subject Satisfaction Questionnaire (SSQ) at Week 40
Description	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.
Time Frame	At Week 40

Outcome Measure Data

Analysis Population Description

All treated population included all participants who used the study drug at least once. Here, number analyzed are number of participants analyzed for given variable.

Arm/Group Title	DB-FMX103 1.5% Minocycline Foam	DB-Vehicle Foam
Arm/Group Description	Enrolled participants from Study FX2016-11 and Study FX2016-12 (FMX103 1.5% group) applied FMX103 1.5% minocycline foam topically to the face once daily for 40 weeks in this present Study FX2016-13. Participants were grouped based on their experience in the previous double-blind study, and that all participants received the study drug in an open-label fashion.	Enrolled participants from Study FX2016-11 and Study FX2016-12 (FMX103 1.5% group) applied FMX103 1.5% minocycline foam topically to the face once daily for 40 weeks in this present Study FX2016-13. Participants were grouped based on their experience in the previous double-blind study, and that all participants received the study drug in an open-label fashion.
Measure Participants	332	172
Easy to Use; 1-Very satisfied	178 53.6%	82 47.7%
Easy to Use; 5-Very dissatisfied	0 0%	2 1.2%
Feel on Skin; 1-Very satisfied	110 33.1%	47 27.3%
Feel on Skin; 5-Very dissatisfied	3 0.9%	3 1.7%
Odor; 1-Very satisfied	155 46.7%	78 45.3%
Odor; 5-Very dissatisfied	0 0%	0 0%
Color; 1-Very satisfied	107 32.2%	44 25.6%
Color; 5-Very dissatisfied	10 3%	7 4.1%
Ease of application; 1-Very satisfied	183 55.1%	88 51.2%
Ease of application; 5-Very dissatisfied	0 0%	0 0%
Ease fitting in to daily routine; 1-Very satisfied	155 46.7%	83 48.3%
Ease fitting in to daily routine; 5-Very dissatisfied	0 0%	0 0%
Compared to Other Products;1-Very satisfied	144 43.4%	70 40.7%
Compared to Other Products; 5-Very dissatisfied	1 0.3%	2 1.2%
Use with other rosacea treatments; 1-Very likely	153 46.1%	74 43%
Use with other rosacea treatments; 5-Very unlikely	3 0.9%	5 2.9%
Recommend to friend; 1-Very likely	156 47%	75 43.6%
Recommend to friend; 5-Very unlikely	3 0.9%	1 0.6%
Overall Satisfaction with Product; 1-Very satisfied	155 46.7%	75 43.6%
Overall Satisfaction with Product; 5-Very dissatisfied	2 0.6%	1 0.6%

7. Secondary Outcome

Title	Number of Participants With Adverse Events (AEs)
Description	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.
Time Frame	Day 0/ Baseline (Final visit of previous DB study [Week 12]) until safety follow-up (Week 44)

Outcome Measure Data

Analysis Population Description

All treated population included all participants who used the study drug at least once.

Arm/Group Title	DB-FMX103 1.5% Minocycline Foam	DB-Vehicle Foam
Arm/Group Description	Enrolled participants from Study FX2016-11 and Study FX2016-12 (FMX103 1.5% group) applied FMX103 1.5% minocycline foam topically to the face once daily for 40 weeks in this present Study FX2016-13. Participants were grouped based on their experience in the previous double-blind study, and that all participants received the study drug in an open-label fashion.	Enrolled participants from Study FX2016-11 and Study FX2016-12 (FMX103 1.5% group) applied FMX103 1.5% minocycline foam topically to the face once daily for 40 weeks in this present Study FX2016-13. Participants were grouped based on their experience in the previous double-blind study, and that all participants received the study drug in an open-label fashion.
Measure Participants	332	172
All AEs	151 45.5%	70 40.7%
TEAEs	137 41.3%	64 37.2%
Serious TEAEs	9 2.7%	4 2.3%
Treatment-related TEAEs	5 1.5%	8 4.7%
Adverse events leading to study discontinuation	3 0.9%	2 1.2%
Participants with any severe TEAE	6 1.8%	6 3.5%
Death	1 0.3%	0 0%

Adverse Events

Time Frame	Day 0/ Baseline (Final visit of previous DB study [Week 12]) until safety follow-up (Week 44)
Arm/Group Title	Minocycline Foam 1.5%		Vehicle Foam
Arm/Group Description	Participants applied FMX103 1.5% minocycline foam topically to the face once daily for 40 weeks.		Participants applied matching vehicle foam topically to the face once daily for 40 weeks.
All Cause Mortality
	Minocycline Foam 1.5%		Vehicle Foam
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/332 (0.3%)		0/172 (0%)
Serious Adverse Events
	Minocycline Foam 1.5%		Vehicle Foam
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/332 (2.7%)		4/172 (2.3%)
Gastrointestinal disorders
Large intestinal obstruction	0/332 (0%)		1/172 (0.6%)
General disorders
Death	1/332 (0.3%)		0/172 (0%)
Infections and infestations
Appendicitis perforated	0/332 (0%)		1/172 (0.6%)
Labyrinthitis	1/332 (0.3%)		0/172 (0%)
Periorbital cellulitis	1/332 (0.3%)		0/172 (0%)
Pneumonia	1/332 (0.3%)		0/172 (0%)
Staphylococcal infection	1/332 (0.3%)		0/172 (0%)
Injury, poisoning and procedural complications
Post procedural haemorrhage	0/332 (0%)		1/172 (0.6%)
Subdural haematoma	1/332 (0.3%)		0/172 (0%)
Metabolism and nutrition disorders
Hypokalaemia	1/332 (0.3%)		0/172 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma	1/332 (0.3%)		0/172 (0%)
Nervous system disorders
Cerebrospinal fluid leakage	1/332 (0.3%)		0/172 (0%)
Cerebrovascular accident	1/332 (0.3%)		0/172 (0%)
Syncope	1/332 (0.3%)		0/172 (0%)
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders	0/332 (0%)		1/172 (0.6%)
Other (Not Including Serious) Adverse Events
	Minocycline Foam 1.5%		Vehicle Foam
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/332 (2.4%)		11/172 (6.4%)
Infections and infestations
Sinusitis	8/332 (2.4%)		11/172 (6.4%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.