Efficacy and Safety of AGN-199201 in Patients With Persistent Erythema Associated With Rosacea

• Sponsor: Allergan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02131636
• Collaborator: (none)
• Enrollment: 440
• Location: 1
• Arms: 2
• Duration (Months): 7
• Patients Per Site Per Month: 62.6

Study Details

Study Description

Brief Summary

This study will evaluate the safety and efficacy of AGN-199201 once daily compared to vehicle for the treatment of persistent moderate to severe facial erythema associated with rosacea.

Condition or Disease	Intervention/Treatment	Phase
Erythema; Rosacea	Drug: AGN-199201; Drug: Vehicle to AGN-199201	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 440 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Study Start Date: May 1, 2014
• Actual Primary Completion Date: Nov 1, 2014
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AGN-199201 AGN-199201 applied to the face once daily for 29 days.	Drug: AGN-199201; AGN-199201 applied to the face once daily for 29 days.
Placebo Comparator: Vehicle Vehicle to AGN-199201 applied to the face once daily for 29 days.	Drug: Vehicle to AGN-199201; Vehicle to AGN-199201 applied to the face once daily for 29 days.

Outcome Measures

Primary Outcome Measures

1. Percentage of Patients With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Satisfaction Assessment (SSA) 5-point Scales [Baseline, Day 29 (Hours 3, 6, 9, and 12)]

   The investigator assessed the patient's overall severity of erythema in the treatment area on the 5 point CEA scale (ranging from 0=clear skin with no signs of erythema to 4=severe erythema/fiery redness). The patient assessed the overall severity of rosacea facial redness in the treatment area on the 5 point SSA scale (ranging from 0=no signs of unwanted redness to 4=severe redness). The percentage of patients with at least a 2 grade decrease (improvement) on both CEA and SSA from baseline was evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) postdose on day 29. Baseline was defined as the measurement at predose on Day 1.

Secondary Outcome Measures

1. Percentage of Patients With at Least a 2-Grade Decrease From Baseline on the SSA 5-point Scale [Baseline, Day 29 (Hours 3, 6, 9, and 12)]

   The patient assessed the overall severity of rosacea facial redness in the treatment area on the 5 point SSA scale (ranging from 0=no signs of unwanted redness to 4=severe redness). The percentage of patients with at least a 2 grade decrease (improvement) from baseline was evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) postdose on day 29. Baseline was defined as the measurement at predose on Day 1.

2. Percent Change From Baseline in Rosacea Facial Redness as Measured by Digital Imaging Analysis (DIA) [Baseline, Day 29 (Hours 3, 6, 9, and 12)]

   Rosacea facial redness in the treatment area was measured by DIA. The percent change was evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) postdose on Day 29. Baseline was defined as the measurement at predose on Day 1. A negative number change from baseline indicates a decrease in facial redness (improvement), and a positive number change from baseline indicates an increase in facial redness (worsening).

3. Percentage of Patients Reporting Treatment Satisfaction on the Satisfaction Assessment for Rosacea Facial Redness (SA-RFR) Questionnaire Item 9 [Day 29 (Hours 3, 6, 9, and 12)]

   The SA-RFR questionnaire item 9 is completed by patients assessing treatment satisfaction on facial redness. Patients reporting treatment satisfaction as "very satisfied" or "satisfied" are noted. The percentage of patients was evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) postdose on Day 29.

4. Change From Baseline on the SA-RFR Questionnaire Item #4 [Baseline, Day 29 (Hours 3, 6, 9, and 12)]

   The SA-RFR questionnaire item 4 is completed by patients assessing how much their face burned due to facial redness on a 5 point scale (range 0=does not burn at all and 4=burns a lot). Patients were evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) postdose on Day 29. A lower score change from baseline (negative number) indicates a decrease in facial redness (improvement), and a higher score change from baseline (positive number) indicates an increase in facial burning (worsening).

5. Percentage of Patients With at Least a 1-Grade Decrease From Baseline on the SSA 5-point Scale [Baseline, Day 1 (Hour 1)]

   The patient assessed the overall severity of rosacea facial redness in the treatment area on the 5 point SSA scale (ranging from 0=no signs of unwanted redness to 4=severe redness). The percentage of patients with at least a 1 grade decrease (improvement) on the SSA from baseline at Day 1 hour 1. Baseline was defined as the measurement at predose on Day 1.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

-Moderate to severe persistent facial erythema associated with rosacea.

Exclusion Criteria:

• Greater than 3 inflammatory lesions on the face

• Current treatment with monoamine oxidase (MAO) inhibitors

• Raynaud's syndrome, narrow angle glaucoma, orthostatic hypotension, scleroderma or Sjogren's syndrome.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Lynchburg	Virginia	United States

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: NCT02131636
• Other Study ID Numbers: 199201-004
• First Posted: May 6, 2014
• Last Update Posted: Nov 18, 2019
• Last Verified: Nov 1, 2019

• Additional relevant MeSH terms: Rosacea; Erythema

Study Results

Participant Flow

Arm/Group Title	AGN-199201	Vehicle
Arm/Group Description	AGN-199201 applied to the face once daily for 29 days.	Vehicle to AGN-199201 applied to the face once daily for 29 days.
Period Title: Overall Study
STARTED	222	218
COMPLETED	210	213
NOT COMPLETED	12	5

Baseline Characteristics

Arm/Group Title	AGN-199201	Vehicle	Total
Arm/Group Description	AGN-199201 applied to the face once daily for 29 days.	Vehicle to AGN-199201 applied to the face once daily for 29 days.	Total of all reporting groups
Overall Participants	222	218	440
Age, Customized (Number) [Number]
18 to 64 years	189 85.1%	194 89%	383 87%
>=65 years	33 14.9%	24 11%	57 13%
Sex: Female, Male (Count of Participants)
Female	172 77.5%	175 80.3%	347 78.9%
Male	50 22.5%	43 19.7%	93 21.1%

Outcome Measures

1. Primary Outcome

Title	Percentage of Patients With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Satisfaction Assessment (SSA) 5-point Scales
Description	The investigator assessed the patient's overall severity of erythema in the treatment area on the 5 point CEA scale (ranging from 0=clear skin with no signs of erythema to 4=severe erythema/fiery redness). The patient assessed the overall severity of rosacea facial redness in the treatment area on the 5 point SSA scale (ranging from 0=no signs of unwanted redness to 4=severe redness). The percentage of patients with at least a 2 grade decrease (improvement) on both CEA and SSA from baseline was evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) postdose on day 29. Baseline was defined as the measurement at predose on Day 1.
Time Frame	Baseline, Day 29 (Hours 3, 6, 9, and 12)

Outcome Measure Data

Analysis Population Description

Intent-to-Treat: all randomized patients

Arm/Group Title	AGN-199201	Vehicle
Arm/Group Description	AGN-199201 applied to the face once daily for 29 days.	Vehicle to AGN-199201 applied to the face once daily for 29 days.
Measure Participants	222	218
Day 29, Hour 3 (N=222, 216)	11.9	5.5
Day 29, Hour 6 (N=222, 216)	15.5	8.3
Day 29, Hour 9 (N=222, 216)	17.7	6.0
Day 29, Hour 12 (N=222, 216)	14.8	6.0

2. Secondary Outcome

Title	Percentage of Patients With at Least a 2-Grade Decrease From Baseline on the SSA 5-point Scale
Description	The patient assessed the overall severity of rosacea facial redness in the treatment area on the 5 point SSA scale (ranging from 0=no signs of unwanted redness to 4=severe redness). The percentage of patients with at least a 2 grade decrease (improvement) from baseline was evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) postdose on day 29. Baseline was defined as the measurement at predose on Day 1.
Time Frame	Baseline, Day 29 (Hours 3, 6, 9, and 12)

Outcome Measure Data

Analysis Population Description

Intent-to-Treat: all randomized patients

Arm/Group Title	AGN-199201	Vehicle
Arm/Group Description	AGN-199201 applied to the face once daily for 29 days.	Vehicle to AGN-199201 applied to the face once daily for 29 days.
Measure Participants	222	218
Day 29, Hour 3	20.1	11.1
Day 29, Hour 6	23.3	12.9
Day 29, Hour 9	23.3	12.0
Day 29, Hour 12	25.0	11.5

3. Secondary Outcome

Title	Percent Change From Baseline in Rosacea Facial Redness as Measured by Digital Imaging Analysis (DIA)
Description	Rosacea facial redness in the treatment area was measured by DIA. The percent change was evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) postdose on Day 29. Baseline was defined as the measurement at predose on Day 1. A negative number change from baseline indicates a decrease in facial redness (improvement), and a positive number change from baseline indicates an increase in facial redness (worsening).
Time Frame	Baseline, Day 29 (Hours 3, 6, 9, and 12)

Outcome Measure Data

Analysis Population Description

Intent-to-Treat: all randomized patients with data at the time point

Arm/Group Title	AGN-199201	Vehicle
Arm/Group Description	AGN-199201 applied to the face once daily for 29 days.	Vehicle to AGN-199201 applied to the face once daily for 29 days.
Measure Participants	222	218
Day 29, Hour 3	-21.37 (94.693)	61.54 (428.943)
Day 29, Hour 6	-14.22 (97.835)	75.09 (498.844)
Day 29, Hour 9	-8.00 (92.893)	71.18 (398.072)
Day 29, Hour 12	-5.35 (98.547)	74.16 (415.301)

4. Secondary Outcome

Title	Percentage of Patients Reporting Treatment Satisfaction on the Satisfaction Assessment for Rosacea Facial Redness (SA-RFR) Questionnaire Item 9
Description	The SA-RFR questionnaire item 9 is completed by patients assessing treatment satisfaction on facial redness. Patients reporting treatment satisfaction as "very satisfied" or "satisfied" are noted. The percentage of patients was evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) postdose on Day 29.
Time Frame	Day 29 (Hours 3, 6, 9, and 12)

Outcome Measure Data

Analysis Population Description

Intent-to-Treat: all randomized patients

Arm/Group Title	AGN-199201	Vehicle
Arm/Group Description	AGN-199201 applied to the face once daily for 29 days.	Vehicle to AGN-199201 applied to the face once daily for 29 days.
Measure Participants	222	218
Day 29, Hour 3	45.9	27.5
Day 29, Hour 6	43.7	24.3
Day 29, Hour 9	43.2	23.4
Day 29, Hour 12	41.9	24.8

5. Secondary Outcome

Title	Change From Baseline on the SA-RFR Questionnaire Item #4
Description	The SA-RFR questionnaire item 4 is completed by patients assessing how much their face burned due to facial redness on a 5 point scale (range 0=does not burn at all and 4=burns a lot). Patients were evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) postdose on Day 29. A lower score change from baseline (negative number) indicates a decrease in facial redness (improvement), and a higher score change from baseline (positive number) indicates an increase in facial burning (worsening).
Time Frame	Baseline, Day 29 (Hours 3, 6, 9, and 12)

Outcome Measure Data

Analysis Population Description

Intent-to-Treat: all randomized patients

Arm/Group Title	AGN-199201	Vehicle
Arm/Group Description	AGN-199201 applied to the face once daily for 29 days.	Vehicle to AGN-199201 applied to the face once daily for 29 days.
Measure Participants	130	149
Baseline	1.8 (0.83)	1.9 (0.85)
Day 29, Hour 3	-1.5 (0.93)	-1.5 (0.95)
Day 29, Hour 6	-1.5 (0.91)	-1.5 (0.98)
Day 29, Hour 9	-1.5 (0.97)	-1.5 (0.96)
Day 29, Hour 12	-1.5 (0.97)	-1.5 (0.95)

6. Secondary Outcome

Title	Percentage of Patients With at Least a 1-Grade Decrease From Baseline on the SSA 5-point Scale
Description	The patient assessed the overall severity of rosacea facial redness in the treatment area on the 5 point SSA scale (ranging from 0=no signs of unwanted redness to 4=severe redness). The percentage of patients with at least a 1 grade decrease (improvement) on the SSA from baseline at Day 1 hour 1. Baseline was defined as the measurement at predose on Day 1.
Time Frame	Baseline, Day 1 (Hour 1)

Outcome Measure Data

Analysis Population Description

Intent-to-Treat: all randomized patients

Arm/Group Title	AGN-199201	Vehicle
Arm/Group Description	AGN-199201 applied to the face once daily for 29 days.	Vehicle to AGN-199201 applied to the face once daily for 29 days.
Measure Participants	222	218
Number [Percentage of Pateints]	30.2	17.4

Adverse Events

Arm/Group Title	AGN-199201		Vehicle
Arm/Group Description	AGN-199201 applied to the face once daily for 29 days.		Vehicle to AGN-199201 applied to the face once daily for 29 days.
All Cause Mortality
	AGN-199201		Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	AGN-199201		Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/222 (0.5%)		3/218 (1.4%)
Cardiac disorders
Atrial Fibrillation	0/222 (0%)		1/218 (0.5%)
Cardiac Failure	0/222 (0%)		1/218 (0.5%)
Arteriosclerosis	0/222 (0%)		1/218 (0.5%)
General disorders
Fall	1/222 (0.5%)		0/218 (0%)
Respiratory, thoracic and mediastinal disorders
Pneumonia	0/222 (0%)		1/218 (0.5%)
Other (Not Including Serious) Adverse Events
	AGN-199201		Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/222 (0%)		0/218 (0%)

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.