A Study to Compare the Efficacy and Safety of Topical Administration of FMX-101 for Treatment of Moderate-to-Severe Acne

• Sponsor: Vyne Therapeutics Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02815267
• Collaborator: (none)
• Enrollment: 466
• Locations: 31
• Arms: 2
• Actual Duration (Months): 17.4
• Patients Per Site: 15
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

This is a Phase 3 study to evaluate the efficacy, safety and long-term safety of the topical administration of FMX-101, 4% minocycline foam for the treatment of moderate-to-severe acne vulgaris.

Condition or Disease	Intervention/Treatment	Phase
Acne Vulgaris	Drug: FMX-101, 4% minocycline foam; Drug: Vehicle Foam	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 466 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-Blind Study to Compare the Efficacy, Safety and Long-Term Safety of Topical Administration of FMX-101 for 1 Year in the Treatment of Moderate-to-Severe Acne Vulgaris, Study FX2014-04
• Actual Study Start Date: May 1, 2016
• Actual Primary Completion Date: Oct 13, 2017
• Actual Study Completion Date: Oct 13, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: FMX-101, 4% minocycline foam Subjects will apply the assigned FMX-101, 4% minocycline foam topically once daily for 12 weeks as directed	Drug: FMX-101, 4% minocycline foam; FMX-101, 4% minocycline foam applied topically once daily for 12 weeks
Placebo Comparator: Vehicle foam Subjects will apply the assigned vehicle foam topically once daily for 12 weeks as directed	Drug: Vehicle Foam; Vehicle foam applied topically once daily for 12 weeks

Outcome Measures

Primary Outcome Measures

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

   To evaluate the efficacy in the treatment of acne compared to vehicle of topical FMX101 4% administered daily for 12 weeks. Changes from Baseline are calculated as Baseline value minus post-Baseline value, so that decreases appear as positive values. Inflammatory lesion count included: papules, pustules, and nodules.

2. Percentage of Participants Achieving Investigator's Global Assessments (IGA) Treatment Success at Week 12 [Baseline and Week 12]

   The IGA scale for acne vulgaris, was used by the investigators to assess the severity of a participant's acne vulgaris. The scale ranges from 0 (Clear): normal, clear skin with no evidence of acne vulgaris to 5 (Very Severe): highly inflammatory lesions predominate, variable number of comedones, many papules/pustules and many nodulocystic lesions. 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. Percent Change From Baseline in the Non-inflammatory Lesion Count at Week 12 [Baseline and Week 12]

   To evaluate the efficacy in the treatment of acne compared to vehicle of topical FMX101 4% administered daily for 12 weeks. Percent change from Baseline is calculated as the Baseline value minus the post-Baseline value divided by the baseline value, expressed as a percentage. Non-inflammatory lesions included: open comedones (blackhead) and closed comedones (whitehead).

2. Absolute Change From Baseline in the Inflammatory Lesion Count at Week 6 and Week 9 [Baseline, at Week 6 and at Week 9]

   To evaluate the efficacy in the treatment of acne compared to vehicle of topical FMX101 4% administered daily for 12 weeks. Changes from Baseline are calculated as Baseline value minus post-Baseline value, so that decreases appear as positive values. Inflammatory lesion count included: papules, pustules, and nodules.

3. Percentage of Participants Achieving IGA Treatment Success at Week 6 and Week 9 [Baseline, at Week 6 and at Week 9]

   The IGA scale for acne vulgaris, was used by the investigators to assess the severity of a participant's acne vulgaris. The scale ranges from 0 (Clear): normal, clear skin with no evidence of acne vulgaris to 5 (Very Severe): highly inflammatory lesions predominate, variable number of comedones, many papules/pustules and many nodulocystic lesions. 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.

4. Number of Participants With Treatment-emergent Adverse Events (TEAEs) and and Treatment-emergent Serious Adverse Events (TESAEs) [Double blind: Screening Day until Week 12; Open-label: Week 16 until Week 52]

   To evaluate the safety compared to vehicle of topical FMX101 4% administered daily for 12 weeks and to evaluate the long-term safety of topical FMX101 4% administered daily for up to an additional 40 weeks. TEAEs of the double-blind phase were defined as AEs starting on or after date of first application of investigational product (IP), but before the date of the first application of the open-label phase, and AEs starting on or after the first application of the open-label phase are considered as TEAEs of the open-label phase.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Has facial acne vulgaris with:

• 20 to 50 inflammatory lesions (papules, pustules, and nodules);

• 25 to 100 noninflammatory lesions (open and closed comedones);

• no more than 2 nodules on the face; and

• IGA score of moderate (3) to severe (4)

• 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:

• 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

• Sunburn on the face

• Severe systemic disease, which might interfere with the conduct of the study or the interpretation of the results.

• Abnormal baseline laboratory values that are considered clinically significant

• Allergy to tetracycline-class antibiotics or to any ingredient in the study drug

• Pseudomembranous colitis or antibiotic-associated colitis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Birmingham	Alabama	United States	35205
2		Fremont	California	United States	94538
3		Fullerton	California	United States	92835
4		Shelton	Connecticut	United States	06484
5		Washington	District of Columbia	United States	20037
6		Boynton Beach	Florida	United States	33437
7		Miami	Florida	United States	33015
8		Miami	Florida	United States	33174
9		Miramar	Florida	United States	33027
10		Sanford	Florida	United States	32771
11		Savannah	Georgia	United States	31406
12		Oakbrook Terrace	Illinois	United States	60181
13		Evansville	Indiana	United States	47713
14		Metairie	Louisiana	United States	70006
15		Rockville	Maryland	United States	20850
16		Bay City	Michigan	United States	48706
17		Omaha	Nebraska	United States	68114
18		Las Vegas	Nevada	United States	89117
19		New York	New York	United States	10012
20		New York	New York	United States	10075
21		High Point	North Carolina	United States	27262
22		Columbus	Ohio	United States	43213
23		Gresham	Oregon	United States	97030
24		Johnston	Rhode Island	United States	02919
25		Murfreesboro	Tennessee	United States	37130
26		Dallas	Texas	United States	75234
27		Plano	Texas	United States	75024
28		San Antonio	Texas	United States	78229
29		West Jordan	Utah	United States	84088
30		Bridgeport	West Virginia	United States	26330
31		San Cristobal		Dominican Republic

Sponsors and Collaborators

• Vyne Therapeutics Inc.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Oct 14, 2016
• Statistical Analysis Plan - Dec 7, 2017

More Information

Publications

None provided.

• Responsible Party: Vyne Therapeutics Inc.
• ClinicalTrials.gov Identifier: NCT02815267
• Other Study ID Numbers: FX2014-04
• First Posted: Jun 28, 2016
• 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
• Keywords provided by Vyne Therapeutics Inc.: acne
• Additional relevant MeSH terms: Acne Vulgaris; Minocycline

Study Results

Participant Flow

Recruitment Details	The study was conducted at 35 sites in the United States and one site in the Dominican Republic from 06 May 2016 to 13 October 2017.
Pre-assignment Detail	The study consisted of a varied screening period. All participants underwent inclusion and exclusion criteria assessment and all eligible participants signed the informed consent before undergoing any study related procedures. All assessments at screening were done as per the schedule of assessment.

Arm/Group Title	FMX-101, 4% Minocycline Foam	Vehicle Foam
Arm/Group Description	Randomized participants applied FMX101 4% topically to the face once daily for 12 weeks as directed.	Randomized participants applied matching vehicle foam topically to the face once daily for 12 weeks as directed.
Period Title: Double-Blind Phase
STARTED	307	159
COMPLETED	274	128
NOT COMPLETED	33	31
Period Title: Double-Blind Phase
STARTED	193	91
COMPLETED	122	50
NOT COMPLETED	71	41

Baseline Characteristics

Arm/Group Title	Double-blind-FMX-101, 4% Minocycline Foam	Double-blind-Vehicle Foam	Total
Arm/Group Description	Randomized participants applied FMX101 4% topically to the face once daily for 12 weeks as directed.	Randomized participants applied matching vehicle foam topically to the face once daily for 12 weeks as directed.	Total of all reporting groups
Overall Participants	307	159	466
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	20.5 (7.5)	20.0 (8.1)	20.3 (7.7)
Sex: Female, Male (Count of Participants)
Female	168 54.7%	98 61.6%	266 57.1%
Male	139 45.3%	61 38.4%	200 42.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	76 24.8%	36 22.6%	112 24%
Not Hispanic or Latino	231 75.2%	123 77.4%	354 76%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	19 6.2%	10 6.3%	29 6.2%
Native Hawaiian or Other Pacific Islander	0 0%	1 0.6%	1 0.2%
Black or African American	86 28%	40 25.2%	126 27%
White	192 62.5%	100 62.9%	292 62.7%
More than one race	10 3.3%	8 5%	18 3.9%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Absolute Change From Baseline in the Inflammatory Lesion Count at Week 12
Description	To evaluate the efficacy in the treatment of acne compared to vehicle of topical FMX101 4% administered daily for 12 weeks. Changes from Baseline are calculated as Baseline value minus post-Baseline value, so that decreases appear as positive values. Inflammatory lesion count included: papules, pustules, and nodules.
Time Frame	Baseline and Week 12

Outcome Measure Data

Analysis Population Description

Intent-to-Treat (ITT) population: included all randomized participants.

Arm/Group Title	FMX-101, 4% Minocycline Foam	Vehicle Foam
Arm/Group Description	Randomized participants applied FMX101 4% topically to the face once daily for 12 weeks as directed.	Randomized participants applied matching vehicle foam topically to the face once daily for 12 weeks as directed.
Measure Participants	307	159
Least Squares Mean (Standard Error) [Lesion counts]	13.95 (0.65)	11.15 (0.90)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	FMX-101, 4% Minocycline Foam, Vehicle Foam
	Comments	Change from baseline in inflammatory lesion count was analyzed using an analysis of covariance (ANCOVA) model, which included treatment, Baseline inflammatory lesion count and pooled investigational site as a blocking factor.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0083
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.80
	Confidence Interval	(2-Sided) 95%; 0.72 to 4.88
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.06
	Estimation Comments

2. Primary Outcome

Title	Percentage of Participants Achieving Investigator's Global Assessments (IGA) Treatment Success at Week 12
Description	The IGA scale for acne vulgaris, was used by the investigators to assess the severity of a participant's acne vulgaris. The scale ranges from 0 (Clear): normal, clear skin with no evidence of acne vulgaris to 5 (Very Severe): highly inflammatory lesions predominate, variable number of comedones, many papules/pustules and many nodulocystic lesions. 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	Baseline and Week 12

Outcome Measure Data

Analysis Population Description

An ITT population: included all randomized participants.

Arm/Group Title	FMX-101, 4% Minocycline Foam	Vehicle Foam
Arm/Group Description	Randomized participants applied FMX101 4% topically to the face once daily for 12 weeks as directed.	Randomized participants applied matching vehicle foam topically to the face once daily for 12 weeks as directed.
Measure Participants	307	159
Number [Percentage of participants]	8.09 2.6%	4.77 3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	FMX-101, 4% Minocycline Foam, Vehicle Foam
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.1805
	Comments	P-value is for the null hypothesis that the combined risk difference equals 0.
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	3.33
	Confidence Interval	(2-Sided) 95%; -1.54 to 8.19
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.48
	Estimation Comments

3. Secondary Outcome

Title	Percent Change From Baseline in the Non-inflammatory Lesion Count at Week 12
Description	To evaluate the efficacy in the treatment of acne compared to vehicle of topical FMX101 4% administered daily for 12 weeks. Percent change from Baseline is calculated as the Baseline value minus the post-Baseline value divided by the baseline value, expressed as a percentage. Non-inflammatory lesions included: open comedones (blackhead) and closed comedones (whitehead).
Time Frame	Baseline and Week 12

Outcome Measure Data

Analysis Population Description

An ITT Population: included all randomized participants.

Arm/Group Title	FMX-101, 4% Minocycline Foam	Vehicle Foam
Arm/Group Description	Randomized participants applied FMX101 4% topically to the face once daily for 12 weeks as directed.	Randomized participants applied matching vehicle foam topically to the face once daily for 12 weeks as directed.
Measure Participants	307	159
Least Squares Mean (Standard Error) [Lesion counts]	32.34 (2.64)	19.60 (3.81)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	FMX-101, 4% Minocycline Foam, Vehicle Foam
	Comments
	Type of Statistical Test	Superiority
	Comments	Percent change from baseline was analyzed using an ANCOVA model, which included treatment, baseline non-inflammatory lesion counts and pooled investigational site as a blocking factor. For the superiority comparison between FMX101 4% and vehicle.
Statistical Test of Hypothesis	p-Value	0.0040
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	12.73
	Confidence Interval	(2-Sided) 95%; 4.07 to 21.39
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 4.42
	Estimation Comments

4. Secondary Outcome

Title	Absolute Change From Baseline in the Inflammatory Lesion Count at Week 6 and Week 9
Description	To evaluate the efficacy in the treatment of acne compared to vehicle of topical FMX101 4% administered daily for 12 weeks. Changes from Baseline are calculated as Baseline value minus post-Baseline value, so that decreases appear as positive values. Inflammatory lesion count included: papules, pustules, and nodules.
Time Frame	Baseline, at Week 6 and at Week 9

Outcome Measure Data

Analysis Population Description

An ITT population: included all randomized participants.

Arm/Group Title	FMX-101, 4% Minocycline Foam	Vehicle Foam
Arm/Group Description	Randomized participants applied FMX101 4% topically to the face once daily for 12 weeks as directed.	Randomized participants applied matching vehicle foam topically to the face once daily for 12 weeks as directed.
Measure Participants	307	159
Week 6	11.65 (0.63)	7.79 (0.87)
Week 9	13.24 (0.63)	8.85 (0.87)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	FMX-101, 4% Minocycline Foam, Vehicle Foam
	Comments
	Type of Statistical Test	Superiority
	Comments	Change from baseline in inflammatory lesion count for Week 6 was analyzed using an ANCOVA model, which included treatment, baseline inflammatory lesion counts and pooled investigational site as a blocking factor.
Statistical Test of Hypothesis	p-Value	0.0002
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	3.86
	Confidence Interval	(2-Sided) 95%; 1.85 to 5.87
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.03
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	FMX-101, 4% Minocycline Foam, Vehicle Foam
	Comments
	Type of Statistical Test	Superiority
	Comments	Change from baseline in inflammatory lesion count for Week 9 was analyzed using an ANCOVA model, which included treatment, baseline inflammatory lesion counts and pooled investigational site as a blocking factor.
Statistical Test of Hypothesis	p-Value	<.0001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	4.39
	Confidence Interval	(2-Sided) 95%; 2.38 to 6.40
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.03
	Estimation Comments

5. Secondary Outcome

Title	Percentage of Participants Achieving IGA Treatment Success at Week 6 and Week 9
Description	The IGA scale for acne vulgaris, was used by the investigators to assess the severity of a participant's acne vulgaris. The scale ranges from 0 (Clear): normal, clear skin with no evidence of acne vulgaris to 5 (Very Severe): highly inflammatory lesions predominate, variable number of comedones, many papules/pustules and many nodulocystic lesions. 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	Baseline, at Week 6 and at Week 9

Outcome Measure Data

Analysis Population Description

An ITT population: included all randomized population.

Arm/Group Title	FMX-101, 4% Minocycline Foam	Vehicle Foam
Arm/Group Description	Randomized participants applied FMX101 4% topically to the face once daily for 12 weeks as directed.	Randomized participants applied matching vehicle foam topically to the face once daily for 12 weeks as directed.
Measure Participants	307	159
Week 6	3.47 1.1%	0.75 0.5%
Week 9	4.19 1.4%	1.43 0.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	FMX-101, 4% Minocycline Foam, Vehicle Foam
	Comments
	Type of Statistical Test	Superiority
	Comments	P-value is for null hypothesis that the combined risk difference equals 0. Percentage of participants achieving IGA treatment success at Week 6
Statistical Test of Hypothesis	p-Value	0.0395
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	2.71
	Confidence Interval	(2-Sided) 95%; 0.13 to 5.3
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.32
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	FMX-101, 4% Minocycline Foam, Vehicle Foam
	Comments
	Type of Statistical Test	Superiority
	Comments	P-value is for null hypothesis that the combined risk difference equals 0. Percentage of participants achieving IGA treatment success at Week 9.
Statistical Test of Hypothesis	p-Value	0.0748
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	2.76
	Confidence Interval	(2-Sided) 95%; -0.28 to 5.80
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.55
	Estimation Comments

6. Secondary Outcome

Title	Number of Participants With Treatment-emergent Adverse Events (TEAEs) and and Treatment-emergent Serious Adverse Events (TESAEs)
Description	To evaluate the safety compared to vehicle of topical FMX101 4% administered daily for 12 weeks and to evaluate the long-term safety of topical FMX101 4% administered daily for up to an additional 40 weeks. TEAEs of the double-blind phase were defined as AEs starting on or after date of first application of investigational product (IP), but before the date of the first application of the open-label phase, and AEs starting on or after the first application of the open-label phase are considered as TEAEs of the open-label phase.
Time Frame	Double blind: Screening Day until Week 12; Open-label: Week 16 until Week 52

Outcome Measure Data

Analysis Population Description

Safety population: included all randomized participants who received IP. Participants who had no post-Baseline assessments were included in the Safety population unless all dispensed IP was returned unused.

Arm/Group Title	Double-blind-FMX-101, 4% Minocycline Foam	Double-blind-Vehicle Foam	Open-label-FMX-101, 4% Minocycline Foam
Arm/Group Description	Randomized participants applied FMX101 4% topically to the face once daily for 12 weeks as directed.	Randomized participants applied matching vehicle foam topically to the face once daily for 12 weeks as directed.	Selected participants from double-blind period received FMX101 4% minocycline foam for additional 40 weeks as directed in open-label period.
Measure Participants	307	159	284
Any TEAE	52 16.9%	29 18.2%	65 13.9%
Any Treatment-related TEAE	6 2%	4 2.5%	5 1.1%
Any Serious TEAE	1 0.3%	0 0%	1 0.2%
Any TEAE Leading to IP Discontinuation	0 0%	3 1.9%	2 0.4%

Adverse Events

Time Frame	Double blind: Screening Day until Week 12; Open-label: Week 16 until Week 52
Arm/Group Title	Double-blind-FMX-101, 4% Minocycline Foam		Double-blind-Vehicle Foam		Open-label-FMX-101, 4% Minocycline Foam
Arm/Group Description	Randomized participants applied FMX101 4% topically to the face once daily for 12 weeks as directed.		Randomized participants applied matching vehicle foam topically to the face once daily for 12 weeks as directed.		Selected participants from double-blind period received FMX101 4% minocycline foam for additional 40 weeks as directed in open-label period.
All Cause Mortality
	Double-blind-FMX-101, 4% Minocycline Foam		Double-blind-Vehicle Foam		Open-label-FMX-101, 4% Minocycline Foam
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/307 (0%)		0/159 (0%)		0/284 (0%)
Serious Adverse Events
	Double-blind-FMX-101, 4% Minocycline Foam		Double-blind-Vehicle Foam		Open-label-FMX-101, 4% Minocycline Foam
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/307 (0.3%)		0/159 (0%)		1/284 (0.4%)
Infections and infestations
Pneumonia	0/307 (0%)		0/159 (0%)		1/284 (0.4%)
Psychiatric disorders
Suicide attempt	1/307 (0.3%)		0/159 (0%)		0/284 (0%)
Other (Not Including Serious) Adverse Events
	Double-blind-FMX-101, 4% Minocycline Foam		Double-blind-Vehicle Foam		Open-label-FMX-101, 4% Minocycline Foam
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	13/307 (4.2%)		11/159 (6.9%)		19/284 (6.7%)
Infections and infestations
Nasopharyngitis	6/307 (2%)		6/159 (3.8%)		10/284 (3.5%)
Influenza	0/307 (0%)		0/159 (0%)		6/284 (2.1%)
Nervous system disorders
Headache	7/307 (2.3%)		5/159 (3.1%)		4/284 (1.4%)

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 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.