Efficacy and Safety Study of CD07805/47 Topical Gel in Subjects With Facial Erythema Associated With Rosacea

• Sponsor: Galderma R&D (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01174030
• Collaborator: (none)
• Enrollment: 269
• Locations: 20
• Arms: 5
• Duration (Months): 5
• Patients Per Site: 13.5
• Patients Per Site Per Month: 2.7

Study Details

Study Description

Brief Summary

The purpose of this vehicle controlled study is to evaluate the efficacy and safety of CD07805/47 gel 0.5% applied topically once daily (QD) for 4 weeks, and CD07805/47 gel 0.18% applied topically once daily (QD) or twice daily (BID) for 4 weeks, in subjects with moderate to severe facial erythema associated with rosacea.

Condition or Disease	Intervention/Treatment	Phase
Rosacea	Drug: CD07805/47 Gel; Drug: Vehicle Gel; Drug: CD07805/47 Gel; Drug: CD07805/47 Gel; Drug: Vehicle Gel	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 269 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A 4-week, Randomized, Double-blind, Parallel-group, Vehicle-controlled, Multicenter Study Investigating the Efficacy and Safety of CD07805/47 Gel 0.5% Applied Topically Once Daily (QD), and CD07805/47 Gel 0.18% Applied Topically Once Daily (QD) or Twice Daily (BID), in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea
• Study Start Date: Aug 1, 2010
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Jan 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CD07805/47 Gel 0.5% QD	Drug: CD07805/47 Gel; CD07805/47 Gel 0.5% QD
Experimental: CD07805/47 Gel 0.18% QD	Drug: CD07805/47 Gel; CD07805/47 Gel 0.18% QD
Experimental: CD07805/47 Gel 0.18% BID	Drug: CD07805/47 Gel; CD07805/47 Gel 0.18% BID
Placebo Comparator: Vehicle Gel QD	Drug: Vehicle Gel; Vehicle Gel QD
Placebo Comparator: Vehicle Gel BID	Drug: Vehicle Gel; Vehicle Gel BID

Outcome Measures

Primary Outcome Measures

1. Composite Success [Day 29]

   Composite success defined as 2-grade improvement on Clinician Erythema Assessment (CEA)and Patient Self Assessment-5 (PSA-5). Each concentration/regimen was compared to its respective placebo control as part of the primary analysis.

Secondary Outcome Measures

1. CEA Success [Day 29]

   CEA success defined as 2-grade improvement on CEA. Each concentration/regimen was compared to its respective placebo control as part of the primary analysis. Clinician Erythema Assessment (CEA) - Grade/Description 0 / Clear Skin with no signs of erythema / Amost clear; slight redness / Mild erythema; definite redness / Moderate erythema; marked redness / Severe erythema; fiery redness

2. PSA-5 Success [day 29]

   Each concentration/regimen was compared to its respective placebo control as part of the primary analysis. PSA-5 success defined as 2-grade improvement on PSA-5. Patient Self Assessment - 5 (PSA-5) - Grade/description 0 / No redness / Very mild redness / Mild redness / Moderate redness / Severe redness

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Male or female, who is at least 18 years of age or older.

• A clinical diagnosis of rosacea.

• A Clinician Erythema Assessment (CEA) score of 3 at Screening and at Pre-dose (T0) on Baseline/Day 1.

• A Patient Self Assessment-5 (PSA-5) score of 3 at Screening and at Pre-dose (T0) on Baseline/Day 1.

• A Patient Self Assessment-11 (PSA-11) score of 5 at Screening and at Pre-dose (T0) on Baseline/Day 1.

Exclusion Criteria:

• Three (3) or more facial inflammatory lesions.

• Current diagnosis of Raynaud's syndrome, thromboangiitis obliterans, orthostatic hypotension, severe cardiovascular disease, cerebral or coronary insufficiency, renal or hepatic impairment, scleroderma, Sjögren's syndrome, or depression.

• Known allergies or sensitivities to any components of the study medications, including the active gel ingredient, brimonidine tartrate.

• Intraocular pressure (IOP) measurement less than 10 mm Hg.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Burke Pharmaceutical Research	Hot Springs	Arkansas	United States	71913
2	University of California at San Francisco	San Francisco	California	United States	94143-0660
3	Meda Phase, Inc	Newnan	Georgia	United States	30263
4	Dermatology Specialists PC	Louisville	Kentucky	United States	40202
5	Minnesota Clinical Study Center	Fridley	Minnesota	United States	55432
6	Central Dermatology, PC	Saint Louis	Missouri	United States	63117
7	Skin Specialty Group	New York	New York	United States	10021
8	Dermatology Laser & Vein Specialists	Charlotte	North Carolina	United States	28207
9	Dermatology Consulting Services	High Point	North Carolina	United States	27262
10	Oregon Dermatology & Research Center	Portland	Oregon	United States	97210
11	Oregon Medical Research	Portland	Oregon	United States	97223
12	Philadelphia Institute of Dermatology	Fort Washington	Pennsylvania	United States	19034
13	DermDox	Hazleton	Pennsylvania	United States	18201
14	Palmetto Clinical Trial Services, LLC	Greenville	South Carolina	United States	29007
15	The Skin Wellness Center	Knoxville	Tennessee	United States	37902
16	Arlington Center for Dermatology	Arlington	Texas	United States	76011
17	Dermatology Treatment & Research Center	Dallas	Texas	United States	75230
18	The Education & Research Foundation	Lynchburg	Virginia	United States	24501
19	Premier Clinical Research	Spokane	Washington	United States	99204
20	Madison Skin & Research	Madison	Wisconsin	United States	53719

Sponsors and Collaborators

• Galderma R&D

Investigators

• Study Director: Michael Graeber, MD, Galderma R&D, Inc
• Principal Investigator: William Abramovits, MD, Dermatology Treatment & Research Center
• Principal Investigator: Fran Cook-Bolden, MD, Skin Specialty Group
• Principal Investigator: Zoe Draelos, MD, Dermatology Consulting Services, High Point NC
• Principal Investigator: Joseph Fowler, MD, Dermatology Specialists, PSC
• Principal Investigator: Kimberly Grande, MD, The Skin Wellness Center
• Principal Investigator: Michael Heffernan, MD, Central Dermatology PC
• Principal Investigator: Steven Kempers, MD, Minnesota Clinical Study Center
• Principal Investigator: Mark Ling, MD, Meda Phase, Inc.
• Principal Investigator: Robert Matheson, MD, Oregon Medical Research
• Principal Investigator: Kappa Meadows, MD, The Education & Research Foundation
• Principal Investigator: Angela Moore, MD, Arlington Center for Dermatology
• Principal Investigator: Girish Munavalli, MD, Dermatology, Laser & Vein Specialists of the Carolinas
• Principal Investigator: Andrew Pollack, MD, Philadelphia Institute of Dermatology
• Principal Investigator: Phoebe Rich, MD, Oregon Dermatology & Research Center
• Principal Investigator: Harry Sharta, MD, Madison Skin & Research
• Principal Investigator: Martin Steinhoff, MD, University of California at San Francisco
• Principal Investigator: Dow Stough, MD, Burke Pharmaceutical Research
• Principal Investigator: William Werschler, MD, Premier Clinical Research
• Principal Investigator: Patricia Westmoreland, MD, Palmetto Clinical Trial Services, LLC
• Principal Investigator: Stephen Schleicher, MD, DermDox

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Galderma R&D
• ClinicalTrials.gov Identifier: NCT01174030
• Other Study ID Numbers: RD.06.SPR.18161
• First Posted: Aug 3, 2010
• Last Update Posted: Feb 26, 2021
• Last Verified: Jan 1, 2014

• Additional relevant MeSH terms: Rosacea; Erythema

Study Results

Participant Flow

Arm/Group Title	CD07805/47 Gel 0.5% QD	CD07805/47 Gel 0.18% QD	CD07805/47 Gel 0.18% BID	Vehicle Gel QD	Vehicle Gel BID
Arm/Group Description	CD07805/47 Gel 0.5% Once Daily	CD07805/47 Gel 0.18% Once Daily	CD07805/47 Gel 0.18% Twice Daily	Vehicle Gel Once Daily	Vehicle Gel Twice Daily
Period Title: Overall Study
STARTED	53	54	54	55	53
COMPLETED	51	52	52	53	52
NOT COMPLETED	2	2	2	2	1

Baseline Characteristics

Arm/Group Title	CD07805/47 Gel 0.5% QD	CD07805/47 Gel 0.18% QD	CD07805/47 Gel 0.18% BID	Vehicle Gel QD	Vehicle Gel BID	Total
Arm/Group Description	Total of all reporting groups
Overall Participants	53	54	54	55	53	269
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	52 98.1%	50 92.6%	50 92.6%	54 98.2%	51 96.2%	257 95.5%
>=65 years	1 1.9%	4 7.4%	4 7.4%	1 1.8%	2 3.8%	12 4.5%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	44.9 (11.50)	46.9 (12.72)	43.2 (12.28)	43.4 (12.73)	43.0 (12.33)	44.3 (12.32)
Sex: Female, Male (Count of Participants)
Female	42 79.2%	44 81.5%	42 77.8%	45 81.8%	44 83%	217 80.7%
Male	11 20.8%	10 18.5%	12 22.2%	10 18.2%	9 17%	52 19.3%
Region of Enrollment (participants) [Number]
United States	53 100%	54 100%	54 100%	55 100%	53 100%	269 100%

Outcome Measures

1. Primary Outcome

Title	Composite Success
Description	Composite success defined as 2-grade improvement on Clinician Erythema Assessment (CEA)and Patient Self Assessment-5 (PSA-5). Each concentration/regimen was compared to its respective placebo control as part of the primary analysis.
Time Frame	Day 29

Outcome Measure Data

Analysis Population Description

Intent-to Treat (ITT) population, LOCF when the data are missing at all four timepoints (i.e. Hours 3, 6, 9, 12) LOCF method will be applied from previous visit.

Arm/Group Title	CD07805/47 Gel 0.5% QD	CD07805/47 Gel 0.18% QD	CD07805/47 Gel 0.18% BID	Vehicle Gel QD	Vehicle Gel BID
Arm/Group Description
Measure Participants	53	54	54	55	53
Day 29/Hour 3	16 30.2%	10 18.5%	10 18.5%	2 3.6%	4 7.5%
Day 29/Hour 6	15 28.3%	10 18.5%	9 16.7%	4 7.3%	7 13.2%
Day 29/Hour 9	17 32.1%	7 13%	11 20.4%	2 3.6%	10 18.9%
Day 29/Hour 12	10 18.9%	5 9.3%	8 14.8%	2 3.6%	9 17%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CD07805/47 Gel 0.5% QD, Vehicle Gel QD
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	GEE:Logit link function
	Comments	Generalized Estimating Equation (GEE) methods with Logit link function and marginal expectation model.
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	8.392
	Confidence Interval	() 95%; 2.637 to 26.710
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	CD07805/47 Gel 0.18% BID, Vehicle Gel BID
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.549
	Comments
	Method	GEE:Logit link function
	Comments	Generalized Estimating Equation (GEE) methods with Logit link function and marginal expectation model.
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.269
	Confidence Interval	() 95%; 0.586 to 2.747
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	CD07805/47 Gel 0.18% QD, Vehicle Gel QD
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.027
	Comments
	Method	GEE:Logit link function
	Comments	Generalized Estimating Equation (GEE) methods with Logit link function and marginal expectation model.
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	3.738
	Confidence Interval	() 95%; 1.097 to 12.742
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	CEA Success
Description	CEA success defined as 2-grade improvement on CEA. Each concentration/regimen was compared to its respective placebo control as part of the primary analysis. Clinician Erythema Assessment (CEA) - Grade/Description 0 / Clear Skin with no signs of erythema / Amost clear; slight redness / Mild erythema; definite redness / Moderate erythema; marked redness / Severe erythema; fiery redness
Time Frame	Day 29

Outcome Measure Data

Analysis Population Description

ITT population, LOCF when the data are missing at all four timepoints (i.e. Hours 3,6,9,12) LOCF method will be applied from the previous visit.

Arm/Group Title	CD07805/47 Gel 0.5% QD	CD07805/47 Gel 0.18% QD	CD07805/47 Gel 0.18% BID	Vehicle Gel QD	Vehicle Gel BID
Arm/Group Description
Measure Participants	53	54	54	55	53
Day 29/Hour 3	27 50.9%	21 38.9%	22 40.7%	12 21.8%	9 17%
Day 29/Hour 6	23 43.4%	21 38.9%	18 33.3%	12 21.8%	12 22.6%
Day 29/Hour 9	26 49.1%	20 37%	23 42.6%	12 21.8%	15 28.3%
Day 29/Hour 12	20 37.7%	17 31.5%	18 33.3%	12 21.8%	16 30.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CD07805/47 Gel 0.5% QD, Vehicle Gel QD
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	.003
	Comments
	Method	GEE:Logit link Function
	Comments	Generalized Estimating Equation (GEE) methods with Logit link function and marginal expectation model
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.683
	Confidence Interval	() 95%; 1.388 to 5.188
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	CD07805/47 Gel 0.18% BID, Vehicle Gel BID
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.056
	Comments
	Method	GEE: Logit link Function
	Comments	Generalized Estimating Equation (GEE) methods with Logit link function and marginal expectation model.
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.892
	Confidence Interval	() 95%; 0.980 to 3.651
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	CD07805/47 Gel 0.18% QD, Vehicle Gel QD
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.074
	Comments
	Method	GEE:Logit link Function
	Comments	Generalized Estimating Equation (GEE) methods with Logit link function and marginal expectation model.
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.885
	Confidence Interval	() 95%; 0.946 to 3.756
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	PSA-5 Success
Description	Each concentration/regimen was compared to its respective placebo control as part of the primary analysis. PSA-5 success defined as 2-grade improvement on PSA-5. Patient Self Assessment - 5 (PSA-5) - Grade/description 0 / No redness / Very mild redness / Mild redness / Moderate redness / Severe redness
Time Frame	day 29

Outcome Measure Data

Analysis Population Description

ITT population, LOCF when the data are missing at all four timepoints (i.e. Hours 3,6,9,12) LOCF method will be applied from the previous visit.

Arm/Group Title	CD07805/47 Gel 0.5% QD	CD07805/47 Gel 0.18% QD	CD07805/47 Gel 0.18% BID	Vehicle Gel QD	Vehicle Gel BID
Arm/Group Description
Measure Participants	53	54	54	55	53
Day 29/Hour 3	25 47.2%	17 31.5%	20 37%	7 12.7%	11 20.8%
Day 29/Hour 6	26 49.1%	13 24.1%	15 27.8%	8 14.5%	11 20.8%
Day 29/Hour 9	22 41.5%	9 16.7%	19 35.2%	5 9.1%	13 24.5%
Day 29/Hour 12	20 37.7%	9 16.7%	16 29.6%	5 9.1%	10 18.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CD07805/47 Gel 0.5% QD, Vehicle Gel QD
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	GEE: Logit link function
	Comments	Generalize Estimating Equation (GEE) methods with Logit link function and marginal expectation model.
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	6.582
	Confidence Interval	() 95%; 2.755 to 15.723
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	CD07805/47 Gel 0.18% BID, Vehicle Gel BID
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.093
	Comments
	Method	GEE: Logit link function
	Comments	Generalized Estimating Equation (GEE) methods with Logit link function and marginal expectation model.
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.853
	Confidence Interval	() 95%; 0.903 to 3.802
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	CD07805/47 Gel 0.18% QD, Vehicle Gel QD
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.054
	Comments
	Method	GEE: Logit link function
	Comments	Generalized Estimating Equation (GEE) methods with Logit link function and marginal expectation model.
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.365
	Confidence Interval	() 95%; 0.960 to 5.825
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Arm/Group Title	CD07805/47 Gel 0.5% QD		CD07805/47 Gel 0.18% QD		CD07805/47 Gel 0.18% BID		Vehicle Gel QD		Vehicle Gel BID
Arm/Group Description
All Cause Mortality
	CD07805/47 Gel 0.5% QD		CD07805/47 Gel 0.18% QD		CD07805/47 Gel 0.18% BID		Vehicle Gel QD		Vehicle Gel BID
	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
	CD07805/47 Gel 0.5% QD		CD07805/47 Gel 0.18% QD		CD07805/47 Gel 0.18% BID		Vehicle Gel QD		Vehicle Gel BID
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/53 (0%)		1/54 (1.9%)		0/54 (0%)		1/55 (1.8%)		0/53 (0%)
Gastrointestinal disorders
Gastric Reflux	0/53 (0%)		1/54 (1.9%)		0/54 (0%)		0/55 (0%)		0/53 (0%)
Vascular disorders
Deep Vein Thrombosis	0/53 (0%)		0/54 (0%)		0/54 (0%)		1/55 (1.8%)		0/53 (0%)
Other (Not Including Serious) Adverse Events
	CD07805/47 Gel 0.5% QD		CD07805/47 Gel 0.18% QD		CD07805/47 Gel 0.18% BID		Vehicle Gel QD		Vehicle Gel BID
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	18/53 (34%)		13/54 (24.1%)		14/54 (25.9%)		16/55 (29.1%)		8/53 (15.1%)
Eye disorders
Intraocular pressure increased	7/53 (13.2%)		6/54 (11.1%)		8/54 (14.8%)		9/55 (16.4%)		4/53 (7.5%)
Infections and infestations
Nasopharyngitis	2/53 (3.8%)		0/54 (0%)		1/54 (1.9%)		3/55 (5.5%)		1/53 (1.9%)
Sinusitis	0/53 (0%)		1/54 (1.9%)		0/54 (0%)		2/55 (3.6%)		3/53 (5.7%)
Nervous system disorders
Headache	4/53 (7.5%)		3/54 (5.6%)		3/54 (5.6%)		1/55 (1.8%)		0/53 (0%)
Skin and subcutaneous tissue disorders
Pruritus	3/53 (5.7%)		3/54 (5.6%)		1/54 (1.9%)		4/55 (7.3%)		0/53 (0%)
Skin Burning Sensation	3/53 (5.7%)		1/54 (1.9%)		2/54 (3.7%)		1/55 (1.8%)		0/53 (0%)
Skin Warm	3/53 (5.7%)		0/54 (0%)		1/54 (1.9%)		0/55 (0%)		0/53 (0%)
Vascular disorders
Flushing	4/53 (7.5%)		1/54 (1.9%)		0/54 (0%)		0/55 (0%)		0/53 (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.