Safety and Efficacy Study of Bimatoprost in the Treatment of Men With Androgenic Alopecia

• Sponsor: Allergan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01325337
• Collaborator: (none)
• Enrollment: 307
• Locations: 2
• Arms: 5
• Duration (Months): 15
• Patients Per Site: 153.5
• Patients Per Site Per Month: 10.2

Study Details

Study Description

Brief Summary

This study will evaluate the safety and efficacy of 3 doses of bimatoprost solution compared with vehicle and over-the-counter (OTC) minoxidil 5% solution in men with androgenic alopecia. All treatments will be provided in a double-blinded fashion except for minoxidil 5% solution which will be provided open-label.

Condition or Disease	Intervention/Treatment	Phase
Alopecia; Alopecia, Androgenetic; Baldness	Drug: bimatoprost Formulation A; Drug: bimatoprost Formulation B; Drug: bimatoprost Formulation C; Drug: bimatoprost vehicle solution; Drug: minoxidil 5% solution	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 307 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Study Start Date: Jun 1, 2011
• Actual Primary Completion Date: Aug 1, 2012
• Actual Study Completion Date: Sep 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: bimatoprost Formulation A Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.	Drug: bimatoprost Formulation A; Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
Experimental: bimatoprost Formulation B Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.	Drug: bimatoprost Formulation B; Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
Experimental: bimatoprost Formulation C Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.	Drug: bimatoprost Formulation C; Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
Placebo Comparator: bimatoprost vehicle solution Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.	Drug: bimatoprost vehicle solution; Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
Active Comparator: minoxidil 5% solution Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.	Drug: minoxidil 5% solution; Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.; Other Names: Rogaine® Regaine®

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Target Area Hair Count (TAHC) [Baseline, Month 6]

   TAHC was measured using digital imaging analysis and was reported in terminal hairs/centimeters squared (cm^2). A positive change from Baseline indicated improvement (increase in the number of terminal hairs).

2. Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score [Baseline, Month 6]

   The SSA score measured scalp hair growth. Using a 7-point scale, participants answered the Question: "Since the start of the study, the amount of my hair has?": Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented.

Secondary Outcome Measures

1. Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score [Baseline, Month 6]

   The investigator compared the participant's scalp hair growth at Month 6 to a photograph of the scalp taken at Baseline and using the 7-point IGA score, the investigator answered the question: "Since the start of the study, the amount of the subject's hair has?": Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented.

2. Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score [Baseline, Month 6]

   At the completion of the study, 3 independent dermatologists using the 7-point GPR score compared photographs of the participant's scalp hair growth at Month 6 to Baseline and answered the question: "Compared with the baseline image, the amount of the subject's hair has?": Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented.

3. Change From Baseline in Target Area Hair Width (TAHW) [Baseline, Month 6]

   Digital imaging analysis was used to measure TAHW in millimeters/centimeters squared (mm/cm^2). The diameters of all terminal hairs (individual hairs ≥ 30 microns in width) in the target area were summed and reported together. A positive change from Baseline indicated improvement (increase in the diameter of terminal hairs).

4. Change From Baseline in Target Area Hair Darkness (TAHD) [Baseline, Month 6]

   Digital imaging analysis was used to measure TAHD. The darkness of all terminal hairs (individual hairs ≥ 30 microns in width) in the target area were summed and divided by total number of terminal hairs in the same target area and was reported as intensity units. A positive change from Baseline indicated improvement (increase in the darkness of terminal hairs).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 49 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Mild to moderate male pattern baldness (androgenic alopecia) with ongoing hair loss for at least 1 year

• Willingness to have micro-dot-tattoo applied to scalp

• Willingness to maintain same hair style, length and hair color during study

Exclusion Criteria:

• Drug or alcohol abuse within 12 months

• HIV positive

• Received hair transplants or had scalp reductions

• Use of hair weaves, hair extensions or wigs within 3 months

• Oral or topical minoxidil treatment within 6 months

• Application of topical steroids or nonsteroidal anti-inflammatory drugs (NSAIDs) to scalp within 4 weeks

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Portland	Oregon	United States
2		Berlin		Germany

Sponsors and Collaborators

• Allergan

Investigators

• Study Director: Medical Director, Allergan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT01325337
• Other Study ID Numbers: 192024-057; 2011-000379-15
• First Posted: Mar 29, 2011
• Last Update Posted: Apr 10, 2014
• Last Verified: Apr 1, 2014

• Additional relevant MeSH terms: Alopecia; Alopecia Areata; Bimatoprost; Minoxidil; Pharmaceutical Solutions

Study Results

Participant Flow

Arm/Group Title	Bimatoprost Formulation A	Bimatoprost Formulation B	Bimatoprost Formulation C	Vehicle to Bimatoprost	Minoxidil 5% Solution
Arm/Group Description	Approximately one milliliter (mL) of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.	Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.	Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.	Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.	Approximately one mL of minoxidil 5% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months.
Period Title: Overall Study
STARTED	61	61	62	62	61
COMPLETED	56	52	53	52	53
NOT COMPLETED	5	9	9	10	8

Baseline Characteristics

Arm/Group Title	Bimatoprost Formulation A	Bimatoprost Formulation B	Bimatoprost Formulation C	Vehicle to Bimatoprost	Minoxidil 5% Solution	Total
Arm/Group Description	Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.	Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.	Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.	Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.	Approximately one mL of minoxidil 5% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months.	Total of all reporting groups
Overall Participants	61	61	62	62	61	307
Age, Customized (Number) [Number]
18 to 34 years	19 31.1%	18 29.5%	20 32.3%	18 29%	18 29.5%	93 30.3%
35 to 50 years	42 68.9%	43 70.5%	42 67.7%	44 71%	43 70.5%	214 69.7%
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Male	61 100%	61 100%	62 100%	62 100%	61 100%	307 100%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Target Area Hair Count (TAHC)
Description	TAHC was measured using digital imaging analysis and was reported in terminal hairs/centimeters squared (cm^2). A positive change from Baseline indicated improvement (increase in the number of terminal hairs).
Time Frame	Baseline, Month 6

Outcome Measure Data

Analysis Population Description

Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure.

Arm/Group Title	Bimatoprost Formulation A	Bimatoprost Formulation B	Bimatoprost Formulation C	Vehicle to Bimatoprost	Minoxidil 5% Solution
Arm/Group Description	Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.	Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.	Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.	Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.	Approximately one mL of minoxidil 5% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months.
Measure Participants	60	61	61	61	61
Baseline	135.0 (58.80)	145.7 (57.25)	151.5 (60.40)	143.7 (55.42)	132.7 (53.14)
Change from Baseline at Month 6	13.1 (21.69)	6.1 (19.80)	6.3 (22.05)	4.1 (15.59)	21.9 (19.30)

2. Primary Outcome

Title	Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score
Description	The SSA score measured scalp hair growth. Using a 7-point scale, participants answered the Question: "Since the start of the study, the amount of my hair has?": Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented.
Time Frame	Baseline, Month 6

Outcome Measure Data

Analysis Population Description

Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure.

Arm/Group Title	Bimatoprost Formulation A	Bimatoprost Formulation B	Bimatoprost Formulation C	Vehicle to Bimatoprost	Minoxidil 5% Solution
Arm/Group Description	Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.	Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.	Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.	Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.	Approximately one mL of minoxidil 5% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months.
Measure Participants	58	59	60	58	58
Greatly Increased	0.0 0%	1.7 2.8%	0.0 0%	1.7 2.7%	5.2 8.5%
Moderately Increased	8.6 14.1%	11.9 19.5%	11.7 18.9%	6.9 11.1%	27.6 45.2%
Slightly Increased	31.0 50.8%	23.7 38.9%	16.7 26.9%	19.0 30.6%	34.5 56.6%
Remained the Same	43.1 70.7%	40.7 66.7%	41.7 67.3%	51.7 83.4%	22.4 36.7%
Slightly Decreased	13.8 22.6%	15.3 25.1%	20.0 32.3%	19.0 30.6%	8.6 14.1%
Moderately Decreased	3.4 5.6%	5.1 8.4%	6.7 10.8%	1.7 2.7%	1.7 2.8%
Greatly Decreased	0.0 0%	1.7 2.8%	3.3 5.3%	0.0 0%	0.0 0%

3. Secondary Outcome

Title	Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score
Description	The investigator compared the participant's scalp hair growth at Month 6 to a photograph of the scalp taken at Baseline and using the 7-point IGA score, the investigator answered the question: "Since the start of the study, the amount of the subject's hair has?": Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented.
Time Frame	Baseline, Month 6

Outcome Measure Data

Analysis Population Description

Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure.

Arm/Group Title	Bimatoprost Formulation A	Bimatoprost Formulation B	Bimatoprost Formulation C	Vehicle to Bimatoprost	Minoxidil 5% Solution
Arm/Group Description	Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.	Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.	Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.	Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.	Approximately one mL of minoxidil 5% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months.
Measure Participants	58	59	61	58	58
Greatly Increased	0.0 0%	5.1 8.4%	0.0 0%	0.0 0%	8.6 14.1%
Moderately Increased	12.1 19.8%	6.8 11.1%	4.9 7.9%	6.9 11.1%	24.1 39.5%
Slightly Increased	29.3 48%	28.8 47.2%	23.0 37.1%	25.9 41.8%	15.5 25.4%
Remained the Same	48.3 79.2%	55.9 91.6%	63.9 103.1%	63.8 102.9%	44.8 73.4%
Slightly Decreased	10.3 16.9%	3.4 5.6%	8.2 13.2%	3.4 5.5%	6.9 11.3%
Moderately Decreased	0.0 0%	0.0 0%	0.0 0%	0.0 0%	0.0 0%
Greatly Decreased	0.0 0%	0.0 0%	0.0 0%	0.0 0%	0.0 0%

4. Secondary Outcome

Title	Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score
Description	At the completion of the study, 3 independent dermatologists using the 7-point GPR score compared photographs of the participant's scalp hair growth at Month 6 to Baseline and answered the question: "Compared with the baseline image, the amount of the subject's hair has?": Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented.
Time Frame	Baseline, Month 6

Outcome Measure Data

Analysis Population Description

Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure.

Arm/Group Title	Bimatoprost Formulation A	Bimatoprost Formulation B	Bimatoprost Formulation C	Vehicle to Bimatoprost	Minoxidil 5% Solution
Arm/Group Description	Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.	Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.	Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.	Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.	Approximately one mL of minoxidil 5% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months.
Measure Participants	57	56	58	56	58
Greatly Increased	0.0 0%	0.0 0%	0.0 0%	0.0 0%	0.0 0%
Moderately Increased	3.5 5.7%	1.8 3%	0.0 0%	0.0 0%	5.2 8.5%
Slightly Increased	17.5 28.7%	10.7 17.5%	8.6 13.9%	8.9 14.4%	39.7 65.1%
Remained the Same	71.9 117.9%	73.2 120%	74.1 119.5%	75.0 121%	50.0 82%
Slightly Decreased	7.0 11.5%	14.3 23.4%	17.2 27.7%	16.1 26%	3.4 5.6%
Moderately Decreased	0.0 0%	0.0 0%	0.0 0%	0.0 0%	1.7 2.8%
Greatly Decreased	0.0 0%	0.0 0%	0.0 0%	0.0 0%	0.0 0%

5. Secondary Outcome

Title	Change From Baseline in Target Area Hair Width (TAHW)
Description	Digital imaging analysis was used to measure TAHW in millimeters/centimeters squared (mm/cm^2). The diameters of all terminal hairs (individual hairs ≥ 30 microns in width) in the target area were summed and reported together. A positive change from Baseline indicated improvement (increase in the diameter of terminal hairs).
Time Frame	Baseline, Month 6

Outcome Measure Data

Analysis Population Description

Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure.

Arm/Group Title	Bimatoprost Formulation A	Bimatoprost Formulation B	Bimatoprost Formulation C	Vehicle to Bimatoprost	Minoxidil 5% Solution
Arm/Group Description	Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.	Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.	Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.	Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.	Approximately one mL of minoxidil 5% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months.
Measure Participants	60	61	61	61	61
Baseline	7.83 (3.879)	8.34 (3.716)	8.59 (3.668)	8.35 (3.494)	7.82 (3.436)
Change from Baseline at Month 6	0.76 (1.390)	0.25 (1.185)	0.12 (1.228)	0.13 (0.839)	1.29 (1.117)

6. Secondary Outcome

Title	Change From Baseline in Target Area Hair Darkness (TAHD)
Description	Digital imaging analysis was used to measure TAHD. The darkness of all terminal hairs (individual hairs ≥ 30 microns in width) in the target area were summed and divided by total number of terminal hairs in the same target area and was reported as intensity units. A positive change from Baseline indicated improvement (increase in the darkness of terminal hairs).
Time Frame	Baseline, Month 6

Outcome Measure Data

Analysis Population Description

Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure.

Arm/Group Title	Bimatoprost Formulation A	Bimatoprost Formulation B	Bimatoprost Formulation C	Vehicle to Bimatoprost	Minoxidil 5% Solution
Arm/Group Description	Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.	Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.	Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.	Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.	Approximately one mL of minoxidil 5% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months.
Measure Participants	60	61	61	61	61
Baseline	106.88 (19.282)	103.85 (21.950)	100.81 (18.041)	104.03 (17.863)	99.57 (28.139)
Change from Baseline at Month 6	1.19 (12.000)	2.92 (14.686)	4.04 (11.061)	0.65 (10.626)	3.40 (12.888)

Adverse Events

Adverse Event Reporting Description	The Safety Population, that consisted of all participants who received at least 1 dose of study treatment, was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
Arm/Group Title	Bimatoprost Formulation A		Bimatoprost Formulation B		Bimatoprost Formulation C		Vehicle to Bimatoprost		Minoxidil 5% Solution
Arm/Group Description	Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.		Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.		Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.		Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.		Approximately one mL of minoxidil 5% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months.
All Cause Mortality
	Bimatoprost Formulation A		Bimatoprost Formulation B		Bimatoprost Formulation C		Vehicle to Bimatoprost		Minoxidil 5% Solution
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Bimatoprost Formulation A		Bimatoprost Formulation B		Bimatoprost Formulation C		Vehicle to Bimatoprost		Minoxidil 5% Solution
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/61 (0%)		1/61 (1.6%)		1/62 (1.6%)		1/62 (1.6%)		0/61 (0%)
Injury, poisoning and procedural complications
Femur fracture	0/61 (0%)		0/61 (0%)		1/62 (1.6%)		0/62 (0%)		0/61 (0%)
Humerus fracture	0/61 (0%)		0/61 (0%)		1/62 (1.6%)		0/62 (0%)		0/61 (0%)
Radius fracture	0/61 (0%)		0/61 (0%)		1/62 (1.6%)		0/62 (0%)		0/61 (0%)
Tibia fracture	0/61 (0%)		0/61 (0%)		1/62 (1.6%)		0/62 (0%)		0/61 (0%)
Wrist fracture	0/61 (0%)		0/61 (0%)		1/62 (1.6%)		0/62 (0%)		0/61 (0%)
Musculoskeletal and connective tissue disorders
Back pain	0/61 (0%)		1/61 (1.6%)		0/62 (0%)		0/62 (0%)		0/61 (0%)
Osteonecrosis	0/61 (0%)		0/61 (0%)		0/62 (0%)		1/62 (1.6%)		0/61 (0%)
Other (Not Including Serious) Adverse Events
	Bimatoprost Formulation A		Bimatoprost Formulation B		Bimatoprost Formulation C		Vehicle to Bimatoprost		Minoxidil 5% Solution
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/61 (9.8%)		11/61 (18%)		4/62 (6.5%)		7/62 (11.3%)		10/61 (16.4%)
General disorders
Application site pruritis	1/61 (1.6%)		4/61 (6.6%)		0/62 (0%)		0/62 (0%)		7/61 (11.5%)
Infections and infestations
Nasopharyngitis	5/61 (8.2%)		7/61 (11.5%)		4/62 (6.5%)		7/62 (11.3%)		3/61 (4.9%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

A 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 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.