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: NCT02815280
• Collaborator: (none)
• Enrollment: 495
• Locations: 36
• Arms: 2
• Actual Duration (Months): 17.4
• Patients Per Site: 13.8
• Patients Per Site Per Month: 0.8

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

Detailed Description

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. The first 12 weeks of the study involves randomized, double-blind treatment with active FMX-101, 4% or matching vehicle. Subjects who successfully complete the 12-week double blind portion of the study will be offered the opportunity to continue in the trial for up to an additional 40 weeks (for a total of 1 year) and receive open-label treatment with FMX-101, 4%.

Study Design

• Study Type: Interventional
• Actual Enrollment: 495 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 FX2014-05
• 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 FMX-101, 4% minocycline foam applied topically once daily for 12 weeks	Drug: FMX-101, 4% minocycline foam; FMX-101, 4% minocycline foam applied topically once daily for 12 weeks
Placebo Comparator: Vehicle Foam Vehicle foam applied topically once daily for 12 weeks	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, Week 6 and 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, Week 6 and 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 Treatment-emergent Serious Adverse Events (TESAEs) [Double blind: From Baseline 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

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Glendale	Arizona	United States	85308
2		Rogers	Arkansas	United States	72758
3		Oceanside	California	United States	92049
4		Denver	Colorado	United States	80220
5		Hialeah	Florida	United States	33016
6		Miami	Florida	United States	33126
7		Miami	Florida	United States	33175
8		Sweetwater	Florida	United States	33172
9		Marietta	Georgia	United States	30060
10		Snellville	Georgia	United States	30078
11		Chicago	Illinois	United States	60611
12		Carmel	Indiana	United States	46032
13		Indianapolis	Indiana	United States	46256
14		Overland Park	Kansas	United States	66215
15		Owensboro	Kentucky	United States	42303
16		Crowley	Louisiana	United States	70526
17		Clarkston	Michigan	United States	48346
18		Detroit	Michigan	United States	48202
19		Montclair	New Jersey	United States	07042
20		Verona	New Jersey	United States	07044
21		Albuquerque	New Mexico	United States	87106
22		Bronx	New York	United States	10458
23		New York	New York	United States	10022
24		Raleigh	North Carolina	United States	27612
25		Cleveland	Ohio	United States	44121
26		Hazleton	Pennsylvania	United States	18201
27		Chattanooga	Tennessee	United States	37421
28		Goodlettsville	Tennessee	United States	37072
29		Austin	Texas	United States	78746
30		New Braunfels	Texas	United States	78130
31		Port Arthur	Texas	United States	77640
32		San Antonio	Texas	United States	78229
33		Sugar Land	Texas	United States	77479
34		Salt Lake City	Utah	United States	84117
35		Seattle	Washington	United States	98104
36		Santo Domingo		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: NCT02815280
• Other Study ID Numbers: FX2014-05
• 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
• 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 36 sites in the United States and one site in the Dominican Republic from 11 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	333	162
COMPLETED	297	137
NOT COMPLETED	36	25
Period Title: Double-Blind Phase
STARTED	256	117
COMPLETED	169	73
NOT COMPLETED	87	44

Baseline Characteristics

Arm/Group Title	FMX-101, 4% Minocycline Foam	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	333	162	495
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	20.5 (7.8)	20.8 (7.9)	20.6 (7.9)
Sex: Female, Male (Count of Participants)
Female	197 59.2%	93 57.4%	290 58.6%
Male	136 40.8%	69 42.6%	205 41.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	127 38.1%	65 40.1%	192 38.8%
Not Hispanic or Latino	206 61.9%	97 59.9%	303 61.2%
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	10 3%	7 4.3%	17 3.4%
Native Hawaiian or Other Pacific Islander	1 0.3%	0 0%	1 0.2%
Black or African American	73 21.9%	30 18.5%	103 20.8%
White	243 73%	124 76.5%	367 74.1%
More than one race	6 1.8%	1 0.6%	7 1.4%
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

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	333	162
Least Squares Mean (Standard Error) [Lesions]	13.78 (0.66)	10.64 (0.94)

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	0.0051
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	3.15
	Confidence Interval	(2-Sided) 95%; 0.95 to 5.35
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.12
	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	333	162
Number [Percentage of participants]	14.66 4.4%	7.89 4.9%

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 the null hypothesis that the combined log (Risk Ratio) equals 0.
Statistical Test of Hypothesis	p-Value	0.0424
	Comments
	Method	Mantel Haenszel
	Comments
Method of Estimation	Estimation Parameter	Risk ratio
	Estimated Value	1.88
	Confidence Interval	(2-Sided) 95%; 1.02 to 3.46
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.31
	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	333	162
Least Squares Mean (Standard Error) [Percent Change]	26.33 (2.88)	13.49 (4.66)

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	0.0155
	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.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	12.84
	Confidence Interval	(2-Sided) 95%; 2.44 to 23.23
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 5.30
	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, Week 6 and 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	333	162
Week 6	12.90 (0.61)	9.01 (0.87)
Week 9	13.42 (0.66)	9.64 (0.94)

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	0.0001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	3.89
	Confidence Interval	(2-Sided) 95%; 1.88 to 5.90
	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	0.0007
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	3.78
	Confidence Interval	(2-Sided) 95%; 1.60 to 5.95
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.11
	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, Week 6 and 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	333	162
Week 6	4.68 1.4%	0.81 0.5%
Week 9	7.61 2.3%	5.97 3.7%

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 the null hypothesis that the combined log (Risk Ratio) equals 0. Percentage of participants achieving IGA treatment success at Week 6.
Statistical Test of Hypothesis	p-Value	0.0071
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	3.87
	Confidence Interval	(2-Sided) 95%; 1.06 to 6.69
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.44
	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
Statistical Test of Hypothesis	p-Value	0.5143
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	1.64
	Confidence Interval	(2-Sided) 95%; -3.30 to 6.58
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.52
	Estimation Comments

6. Secondary Outcome

Title	Number of Participants With Treatment-emergent Adverse Events (TEAEs) 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: From Baseline 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	333	162	373
Any TEAE	110 33%	45 27.8%	120 24.2%
Any Treatment-related TEAE	9 2.7%	3 1.9%	8 1.6%
Any Serious TEAE	4 1.2%	2 1.2%	1 0.2%
Any TEAE Leading to IP discontinuation	1 0.3%	1 0.6%	5 1%

Adverse Events

Time Frame	Double blind: From Baseline 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	0/333 (0%)		0/162 (0%)		0/373 (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	4/333 (1.2%)		2/162 (1.2%)		1/373 (0.3%)
General disorders
Intestinal obstruction	1/333 (0.3%)		0/162 (0%)		0/373 (0%)
Intestinal perforation	1/333 (0.3%)		0/162 (0%)		0/373 (0%)
Fatigue	0/333 (0%)		0/162 (0%)		1/373 (0.3%)
Hepatobiliary disorders
Biliary dyskinesia	0/333 (0%)		1/162 (0.6%)		0/373 (0%)
Cholecystitis	0/333 (0%)		1/162 (0.6%)		0/373 (0%)
Infections and infestations
Pneumonia	0/333 (0%)		1/162 (0.6%)		0/373 (0%)
Injury, poisoning and procedural complications
Facial bones fracture	1/333 (0.3%)		0/162 (0%)		0/373 (0%)
Head injury	0/333 (0%)		0/162 (0%)		1/373 (0.3%)
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy	1/333 (0.3%)		0/162 (0%)		0/373 (0%)
Respiratory, thoracic and mediastinal disorders
Asthma	1/333 (0.3%)		0/162 (0%)		0/373 (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	40/333 (12%)		15/162 (9.3%)		38/373 (10.2%)
Infections and infestations
Nasopharyngitis	24/333 (7.2%)		7/162 (4.3%)		23/373 (6.2%)
Nervous system disorders
Headache	21/333 (6.3%)		9/162 (5.6%)		17/373 (4.6%)

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.