A Study to Evaluate the Efficacy and Safety of Topical Administration of FMX101 in the Treatment of Moderate-to-Severe Acne Vulgaris

• Sponsor: Vyne Therapeutics Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03271021
• Collaborator: (none)
• Enrollment: 1,488
• Locations: 98
• Arms: 2
• Actual Duration (Months): 13.6
• Patients Per Site: 15.2
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

A Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Efficacy and Safety of Topical Administration of FMX101 for 12 Weeks in the Treatment of Moderate-to-Severe Acne Vulgaris (Study FX2017-22)

Condition or Disease	Intervention/Treatment	Phase
Acne Vulgaris	Drug: FMX101; Drug: Vehicle Foam	Phase 3

Detailed Description

This is a randomized, multicenter, double-blind, vehicle-controlled, 2 arm study to evaluate the safety and efficacy over 12 weeks of FMX101 topical foam containing 4% minocycline compared to vehicle in the treatment of subjects with moderate-to-severe facial acne vulgaris. Qualified subjects will be randomized to receive 1 of the following 2 treatments:

• FMX101 4% minocycline foam

• Vehicle foam

Study Design

• Study Type: Interventional
• Actual Enrollment: 1488 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Efficacy and Safety of Topical Administration of FMX101 for 12 Weeks in the Treatment of Moderate-to-Severe Acne Vulgaris (Study FX2017-22)
• Actual Study Start Date: Jul 17, 2017
• Actual Primary Completion Date: Sep 4, 2018
• Actual Study Completion Date: Sep 4, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: FMX101, 4% minocycline foam FMX101, 4% minocycline foam applied topically once daily for 12 weeks	Drug: FMX101; FMX101, 4% minocycline foam
Placebo Comparator: Vehicle foam Vehicle foam applied topically once daily for 12 weeks	Drug: Vehicle Foam; Vehicle Foam

Outcome Measures

Primary Outcome Measures

1. The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 12. [12 weeks]

   A decrease in the inflammatory lesion count from Baseline to Week 12.

2. Investigator Global Assessment (IGA) Treatment Success (Dichotomized as Yes/no) at Week 12, Where Success is Defined as an IGA Score of 0 or 1, and at Least a 2-grade Improvement (Decrease) From Baseline [12 weeks]

Secondary Outcome Measures

1. The Absolute Change From Baseline in the Non-inflammatory Lesion Count at Week 12 [12 weeks]

2. The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 9 [9 weeks]

3. The Absolute Change From Baseline in the Inflammatory Lesion Count at the Interim Visit at Week 6 [6 weeks]

4. IGA Treatment Success (Dichotomized as Yes/no) at Week 6, Where Success is Defined as an IGA Score of 0 or 1, and at Least a 2-grade Improvement (Decrease) From Baseline at the Interim Visit at Week 6 [6 weeks]

5. IGA Treatment Success (Dichotomized as Yes/no) at Week 9, Where Success is Defined as an IGA Score of 0 or 1, and at Least a 2-grade Improvement (Decrease) From Baseline at the Interim Visit at Week 9 [9 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 9 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Has facial acne vulgaris with:

2. 20 to 50 inflammatory lesions (papules, pustules, and nodules)

3. 25 to 100 non-inflammatory lesions (open and closed comedones)

4. No more than 2 nodules on the face

5. IGA score of moderate (3) to severe (4)

6. Willing to use only the supplied non-medicated cleanser (Cetaphil Gentle Skin Cleanser) and to refrain from use of any other acne medication, medicated cleanser, excessive sun exposure, and tanning booths for the duration of the study.

Exclusion Criteria:

1. Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne), or any dermatological condition of the face or facial hair (eg, beard, sideburns, mustache) that could interfere with the clinical evaluations.

2. Sunburn on the face.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Foamix Investigational Site #376	Phoenix	Arizona	United States	85023
2	Foamix Investigational Site #395	Tucson	Arizona	United States	85712
3	Foamix Investigational Site #315	Bryant	Arkansas	United States	72022
4	Foamix Investigational Site #340	Fort Smith	Arkansas	United States	72916
5	Foamix Investigational SIte #377	Little Rock	Arkansas	United States	72212
6	Foamix Investigational Site #366	Encino	California	United States	91436
7	Foamix Investigational Site #403	Los Angeles	California	United States	90036
8	Foamix Investigational Site #303	Murrieta	California	United States	92562
9	Foamix Investigational Site #369	Northridge	California	United States	91324
10	Foamix Investigational Site #387	Palm Springs	California	United States	92262
11	Foamix Investigational Site #393	Pasadena	California	United States	91105
12	Foamix Investigational Site #380	Poway	California	United States	92064
13	Foamix Investigational Site # 328	Sacramento	California	United States	95819
14	Foamix Investigational Site #313	San Diego	California	United States	92123
15	Foamix Investigational Site #336	San Luis Obispo	California	United States	93405
16	Foamix Investigational Site #309	Santa Ana	California	United States	92705
17	Foamix Investigational Site #325	Santa Monica	California	United States	90403
18	Foamix Investigational Site #375	Temecula	California	United States	92592
19	Foamix Investigational Site #381	Aventura	Florida	United States	33180
20	Foamix Investigational SIte #371	Boca Raton	Florida	United States	33431
21	Foamix Investigational Site #311	Boca Raton	Florida	United States	33486
22	Foamix Investigational Site #398	Brandon	Florida	United States	33511
23	Foamix Investigational Site #329	Clearwater	Florida	United States	33756
24	Foamix Investigational Site #378	Davie	Florida	United States	33328
25	Foamix Investigational Site #396	DeLand	Florida	United States	32720
26	Foamix Investigational Site #392	Doral	Florida	United States	33126
27	Foamix Investigational Site #318	Fort Myers	Florida	United States	33912
28	Foamix Investigational Site #401	Hialeah	Florida	United States	33015
29	Foamix Investigational Site #400	Hialeah	Florida	United States	33016
30	Foamix Investigational Site #383	Lake Worth	Florida	United States	33467
31	Foamix Investigational Site #346	Miami Lakes	Florida	United States	33016
32	Foamix Investigational Site #347	Miami Lakes	Florida	United States	33104
33	Foamix Investigational Site #397	Miami	Florida	United States	33126
34	Foamix Investigational Site #370	Miami	Florida	United States	33155
35	Foamix Investigational Site #306	North Miami Beach	Florida	United States	33162
36	Foamix Investigational Site #312	Ormond Beach	Florida	United States	32174
37	Foamix Investigational Site #362	South Miami	Florida	United States	33143
38	Foamix Investigational SIte #382	Tamarac	Florida	United States	33321
39	Foamix Investigational Site #399	Tampa	Florida	United States	33609
40	Foamix Investigational Site #385	Tampa	Florida	United States	33624
41	Foamix Investigational Site #394	Tampa	Florida	United States	33634
42	Foamix Investigational Site #360	West Palm Beach	Florida	United States	33406
43	Foamix Investigational Site #368	Columbus	Georgia	United States	31904
44	Foamix Investigational Site #336	Sandy Springs	Georgia	United States	30328
45	Foamix Investigational Site #384	Nampa	Idaho	United States	83651
46	Foamix Investigational Site #345	Skokie	Illinois	United States	60077
47	Foamix Investigational Site #390	West Dundee	Illinois	United States	60118
48	Foamix Investigational Site #365	Indianapolis	Indiana	United States	46256
49	Foamix Investigational Site #316	New Albany	Indiana	United States	47150
50	Foamix Investigational Site #361	Plainfield	Indiana	United States	46168
51	Foamix Investigational Site #331	South Bend	Indiana	United States	46617
52	Foamix Investigational Site #320	Louisville	Kentucky	United States	40217
53	Foamix Investigational SIte #367	Louisville	Kentucky	United States	40241
54	Foamix Investigational Site #317	New Orleans	Louisiana	United States	70115
55	Foamix Investigational SIte #373	New Orleans	Louisiana	United States	70124
56	Foamix Investigational Site #388	Glenn Dale	Maryland	United States	20769
57	Foamix Investigational Site #304	Beverly	Massachusetts	United States	01915
58	Foamix Investigational Site #314	Brighton	Massachusetts	United States	02135
59	Foamix Investigational Site #334	Watertown	Massachusetts	United States	02472
60	Foamix Investigational Site #322	Saint Joseph	Missouri	United States	64506
61	Foamix Investigational Site #372	Saint Louis	Missouri	United States	63141
62	Foamix Investigational Site #391	Lincoln	Nebraska	United States	68502
63	Foamix Investigational Site # 327	Omaha	Nebraska	United States	68144
64	Foamix Investigational Site #332	Las Vegas	Nevada	United States	89728
65	Foamix Investigational Site #344	Portsmouth	New Hampshire	United States	03801
66	Foamix Investigational Site #356	Berlin	New Jersey	United States	08009
67	Foamix Investigational Site #337	Verona	New Jersey	United States	07044
68	Foamix Investigational Site #321	Charlotte	New York	United States	28277
69	Foamix Investigational Site #355	New York	New York	United States	10016
70	Foamix Investigational Site #363	New York	New York	United States	10155
71	Foamix Investigational Site #307	Stony Brook	New York	United States	11790
72	Foamix Investigational Site #350	Charlotte	North Carolina	United States	28277
73	Foamix Investigational Site #348	Winston-Salem	North Carolina	United States	27104
74	Foamix Investigational Site #364	Fargo	North Dakota	United States	58103
75	Foamix Investigational Site #310	Bexley	Ohio	United States	43209
76	Foamix Investigational Site #386	Cincinnati	Ohio	United States	45212
77	Foamix Investigational Site #353	Cleveland	Ohio	United States	44122
78	Foamix Investigational Site #330	Dublin	Ohio	United States	43016
79	Foamix Investigational Site #302	Norman	Oklahoma	United States	73071
80	Foamix Investigational Site #335	Exton	Pennsylvania	United States	19341
81	Foamix Investigational Site #349	Hershey	Pennsylvania	United States	17033
82	Foamix Investigational Site #323	Jenkintown	Pennsylvania	United States	19046
83	Foamix Investigational Site #319	Charleston	South Carolina	United States	29407
84	Foamix Investigational Site #305	Mount Pleasant	South Carolina	United States	29464
85	Foamix Investigational Site #308	Knoxville	Tennessee	United States	37922
86	Foamix Research Site # 301	Arlington	Texas	United States	76011
87	Foamix Investigational Site #374	Arlington	Texas	United States	76014
88	Foamix Investigational SIte #341	Austin	Texas	United States	78704
89	Foamix Investigational Site #351	Austin	Texas	United States	78705
90	Foamix Investigational Site #402	Bryan	Texas	United States	77802
91	Foamix Investigational Site #358	Dallas	Texas	United States	75231
92	Foamix Investigational Site #333	Houston	Texas	United States	77004
93	Foamix Investigational Site #352	Houston	Texas	United States	77056
94	Foamix Investigational Site # 324	Pflugerville	Texas	United States	78660
95	Foamix Investigational SIte #379	Lynchburg	Virginia	United States	24501
96	Foamix Investigational Site #343	Norfolk	Virginia	United States	235070
97	Foamix Investigational Site #389	Seattle	Washington	United States	98168
98	Foamix Investigational Site #359	Tacoma	Washington	United States	98405

Sponsors and Collaborators

• Vyne Therapeutics Inc.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Jun 22, 2017
• Statistical Analysis Plan - Aug 17, 2018

More Information

Publications

None provided.

• Responsible Party: Vyne Therapeutics Inc.
• ClinicalTrials.gov Identifier: NCT03271021
• Other Study ID Numbers: FX2017-22
• First Posted: Sep 1, 2017
• Last Update Posted: Jan 18, 2022
• Last Verified: Jan 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Acne Vulgaris; Minocycline

Study Results

Participant Flow

Arm/Group Title	FMX101, 4% Minocycline Foam	Vehicle Foam
Arm/Group Description	FMX101, 4% minocycline foam applied topically once daily for 12 weeks FMX101: FMX101, 4% minocycline foam	Vehicle foam applied topically once daily for 12 weeks Vehicle Foam: Vehicle Foam
Period Title: Overall Study
STARTED	738	750
COMPLETED	649	644
NOT COMPLETED	89	106

Baseline Characteristics

Arm/Group Title	FMX101, 4% Minocycline Foam	Vehicle Foam	Total
Arm/Group Description	FMX101, 4% minocycline foam applied topically once daily for 12 weeks FMX101: FMX101, 4% minocycline foam	Vehicle foam applied topically once daily for 12 weeks Vehicle Foam: Vehicle Foam	Total of all reporting groups
Overall Participants	738	750	1488
Age, Customized (Count of Participants)
9-12	42 5.7%	41 5.5%	83 5.6%
13-17	321 43.5%	309 41.2%	630 42.3%
≥ 18	375 50.8%	400 53.3%	775 52.1%
Sex: Female, Male (Count of Participants)
Female	460 62.3%	469 62.5%	929 62.4%
Male	278 37.7%	281 37.5%	559 37.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	266 36%	252 33.6%	518 34.8%
Not Hispanic or Latino	472 64%	498 66.4%	970 65.2%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 0.1%	3 0.4%	4 0.3%
Asian	25 3.4%	29 3.9%	54 3.6%
Native Hawaiian or Other Pacific Islander	2 0.3%	4 0.5%	6 0.4%
Black or African American	125 16.9%	144 19.2%	269 18.1%
White	571 77.4%	560 74.7%	1131 76%
More than one race	14 1.9%	10 1.3%	24 1.6%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 12.
Description	A decrease in the inflammatory lesion count from Baseline to Week 12.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FMX101, 4% Minocycline Foam	Vehicle Foam
Arm/Group Description	FMX101, 4% minocycline foam applied topically once daily for 12 weeks FMX101: FMX101, 4% minocycline foam	Vehicle foam applied topically once daily for 12 weeks Vehicle Foam: Vehicle Foam
Measure Participants	738	750
Least Squares Mean (95% Confidence Interval) [Lesion Count]	16.39	12.74

2. Primary Outcome

Title	Investigator Global Assessment (IGA) Treatment Success (Dichotomized as Yes/no) at Week 12, Where Success is Defined as an IGA Score of 0 or 1, and at Least a 2-grade Improvement (Decrease) From Baseline
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FMX101, 4% Minocycline Foam	Vehicle Foam
Arm/Group Description	FMX101, 4% minocycline foam applied topically once daily for 12 weeks FMX101: FMX101, 4% minocycline foam	Vehicle foam applied topically once daily for 12 weeks Vehicle Foam: Vehicle Foam
Measure Participants	738	750
Number [participants]	199 27%	133 17.7%

3. Secondary Outcome

Title	The Absolute Change From Baseline in the Non-inflammatory Lesion Count at Week 12
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FMX101, 4% Minocycline Foam	Vehicle Foam
Arm/Group Description	FMX101, 4% minocycline foam applied topically once daily for 12 weeks FMX101: FMX101, 4% minocycline foam	Vehicle foam applied topically once daily for 12 weeks Vehicle Foam: Vehicle Foam
Measure Participants	626	622
Least Squares Mean (95% Confidence Interval) [Lesion Count]	18.80	15.89

4. Secondary Outcome

Title	The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 9
Time Frame	9 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FMX101, 4% Minocycline Foam	Vehicle Foam
Arm/Group Description	FMX101, 4% minocycline foam applied topically once daily for 12 weeks FMX101: FMX101, 4% minocycline foam	Vehicle foam applied topically once daily for 12 weeks Vehicle Foam: Vehicle Foam
Measure Participants	738	750
Least Squares Mean (95% Confidence Interval) [Lesion Count]	15.59	11.72

5. Secondary Outcome

Title	The Absolute Change From Baseline in the Inflammatory Lesion Count at the Interim Visit at Week 6
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FMX101, 4% Minocycline Foam	Vehicle Foam
Arm/Group Description	FMX101, 4% minocycline foam applied topically once daily for 12 weeks FMX101: FMX101, 4% minocycline foam	Vehicle foam applied topically once daily for 12 weeks Vehicle Foam: Vehicle Foam
Measure Participants	738	750
Least Squares Mean (95% Confidence Interval) [Lesion Count]	13.09	9.57

6. Secondary Outcome

Title	IGA Treatment Success (Dichotomized as Yes/no) at Week 6, Where Success is Defined as an IGA Score of 0 or 1, and at Least a 2-grade Improvement (Decrease) From Baseline at the Interim Visit at Week 6
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FMX101, 4% Minocycline Foam	Vehicle Foam
Arm/Group Description	FMX101, 4% minocycline foam applied topically once daily for 12 weeks FMX101: FMX101, 4% minocycline foam	Vehicle foam applied topically once daily for 12 weeks Vehicle Foam: Vehicle Foam
Measure Participants	738	750
Number [participants]	84 11.4%	46 6.1%

7. Secondary Outcome

Title	IGA Treatment Success (Dichotomized as Yes/no) at Week 9, Where Success is Defined as an IGA Score of 0 or 1, and at Least a 2-grade Improvement (Decrease) From Baseline at the Interim Visit at Week 9
Time Frame	9 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FMX101, 4% Minocycline Foam	Vehicle Foam
Arm/Group Description	FMX101, 4% minocycline foam applied topically once daily for 12 weeks FMX101: FMX101, 4% minocycline foam	Vehicle foam applied topically once daily for 12 weeks Vehicle Foam: Vehicle Foam
Measure Participants	738	750
Number [participants]	137 18.6%	79 10.5%

Adverse Events

Time Frame	Up to 16 weeks
Adverse Event Reporting Description	Number of participants represents the Safety Population.
Arm/Group Title	FMX101, 4% Minocycline Foam		Vehicle Foam
Arm/Group Description	FMX101, 4% minocycline foam applied topically once daily for 12 weeks FMX101: FMX101, 4% minocycline foam		Vehicle foam applied topically once daily for 12 weeks Vehicle Foam: Vehicle Foam
All Cause Mortality
	FMX101, 4% Minocycline Foam		Vehicle Foam
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/737 (0%)		0/747 (0%)
Serious Adverse Events
	FMX101, 4% Minocycline Foam		Vehicle Foam
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/737 (0.1%)		4/747 (0.5%)
Gastrointestinal disorders
Chron's disease	0/737 (0%)	0	3/747 (0.4%)	3
Hepatobiliary disorders
Cholecystitis	0/737 (0%)	0	1/747 (0.1%)	1
Pregnancy, puerperium and perinatal conditions
Pregnancy	1/737 (0.1%)	1	1/747 (0.1%)	1
Other (Not Including Serious) Adverse Events
	FMX101, 4% Minocycline Foam		Vehicle Foam
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/737 (0%)		0/747 (0%)

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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.