Phase 3 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: NCT01355458
• Collaborator: (none)
• Enrollment: 260
• Locations: 15
• Arms: 2
• Duration (Months): 7
• Patients Per Site: 17.3
• Patients Per Site Per Month: 2.5

Study Details

Study Description

Brief Summary

Phase 3 efficacy and safety study of CD07805/47 topical gel in subjects with facial erythema associated with rosacea. The study hypothesis is that CD07805/47 gel, applied topically once daily is more efficacious than vehicle and provides an acceptable safety profile in the treatment of facial erythema associated with rosacea.

Condition or Disease	Intervention/Treatment	Phase
Rosacea	Drug: CD07805/47 gel; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 260 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Randomized Double-Blind, Vehicle-Controlled, Parallel Group Study to Demonstrate the Efficacy and Safety of CD07805/47 Gel Applied Topically Once Daily in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea
• Study Start Date: May 1, 2011
• Actual Primary Completion Date: Sep 1, 2011
• Actual Study Completion Date: Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CD07805/47 gel	Drug: CD07805/47 gel; applied topically once daily
Placebo Comparator: Placebo	Drug: Placebo; applied topically once daily

Outcome Measures

Primary Outcome Measures

1. Composite Success [Day 29]

   Composite Success is defined as 2-grade improvement on both Clinician Erythema Assessment (CEA) and Patient Self Assessment(PSA).

Eligibility Criteria

Criteria

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

Key Inclusion Criteria:

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

2. A clinical diagnosis of facial rosacea.

3. A Clinician Erythema Assessment (CEA) score of greater than or equal to 3 at Screening and at Baseline/Day 1 (prior to the study drug application).

4. A Patient Self Assessment (PSA) score of greater than or equal to 3 at Screening and at Baseline/Day 1 (prior to the study drug application).

Key Exclusion Criteria:

1. Particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin) or other concomitant facial dermatoses that are similar to rosacea such as peri-oral dermatitis, demodicidosis, facial keratosis pilaris, seborrheic dermatitis, acute lupus erythematosus, or actinic telangiectasia.

2. Presence of three (3) or more facial inflammatory lesions of rosacea.

3. Current treatment with monoamine oxidase (MAO) inhibitors, barbiturates, opiates, sedatives, systemic anesthetics, or alpha agonists.

4. Less than 3 months stable dose treatment with tricyclic antidepressants, cardiac glycosides, beta blockers or other antihypertensive agents.

5. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dermatology Research Associates	Los Angeles	California	United States	90045
2	University of California, San Francisco	San Francisco	California	United States	94143
3	Michigan Center for Skin Care Research	Clinton Township	Michigan	United States	48038
4	Windsor Dermatology	East Windsor	New Jersey	United States	08520
5	Dermatology Consulting Services	High Point	North Carolina	United States	27262
6	Oregon Medical Research Center	Portland	Oregon	United States	97223
7	Philadelphia Institute of Dermatology	Fort Washington	Pennsylvania	United States	19034
8	The Skin Wellness Center	Knoxville	Tennessee	United States	37922
9	Arlington Center for Dermatology	Arlington	Texas	United States	76011
10	DermResearch, Inc.	Austin	Texas	United States	78759
11	Dermatology Treatment & Research Center	Dallas	Texas	United States	72230
12	The Education & Research Foundation, Inc.	Lynchburg	Virginia	United States	24501
13	Lynderm Research Inc	Markham	Ontario	Canada	L3P 1A8
14	Windsor Clinical Research Inc.	Windsor	Ontario	Canada	N8W 5L7
15	Innovaderm Research, Inc	Montreal	Quebec	Canada	H2K 4L5

Sponsors and Collaborators

• Galderma R&D

Investigators

• Study Chair: Michael Graeber, MD, Galderma R&D
• Principal Investigator: William Abramovits, MD, Dermatology Treatment & Research Center
• Principal Investigator: Robert Bissonette, MD, Innovaderm Research Inc.
• Principal Investigator: Zoe Draelos, MD, Dermatology Consulting Services, High Point NC
• Principal Investigator: Kimberly Grande, MD, The Skin Wellness Center
• Principal Investigator: Michael Jarratt, MD, Derm Research, PLLC
• Principal Investigator: Charles Lynde, MD, Lynderm Research Inc
• Principal Investigator: Robert Matheson, MD, Oregon Medical Research Center
• Principal Investigator: Kappa Meadows, MD, The Education & Research Foundation, Inc.
• Principal Investigator: Angela Moore, MD, Arlington Center for Dermatology
• Principal Investigator: David Nieves, MD, Windsor Dermatology
• Principal Investigator: Andrew Pollack, MD, Philadelphia Institute of Dermatology
• Principal Investigator: Howard Sofen, MD, Dermatology Research Associates
• Principal Investigator: Martin Steinhoff, MD, University of California, San Francisco
• Principal Investigator: Daniel Stewart, DO, Michigan Center for Skin Care Research
• Principal Investigator: Jerry Tan, MD, Windsor Clinical Research Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Galderma R&D
• ClinicalTrials.gov Identifier: NCT01355458
• Other Study ID Numbers: RD.06.SPR.18140
• First Posted: May 18, 2011
• Last Update Posted: Feb 18, 2021
• Last Verified: Sep 1, 2013

• Keywords provided by Galderma R&D: rosacea
• Additional relevant MeSH terms: Rosacea; Erythema

Study Results

Participant Flow

Arm/Group Title	CD07805/47 Gel	Placebo
Arm/Group Description
Period Title: Overall Study
STARTED	129	131
COMPLETED	127	127
NOT COMPLETED	2	4

Baseline Characteristics

Arm/Group Title	CD07805/47 Gel	Placebo	Total
Arm/Group Description	Total of all reporting groups
Overall Participants	129	131	260
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	117 90.7%	117 89.3%	234 90%
>=65 years	12 9.3%	14 10.7%	26 10%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	49.5 (11.76)	48.1 (12.81)	48.8 (12.30)
Sex: Female, Male (Count of Participants)
Female	104 80.6%	102 77.9%	206 79.2%
Male	25 19.4%	29 22.1%	54 20.8%
Region of Enrollment (participants) [Number]
United States	115 89.1%	116 88.5%	231 88.8%
Canada	14 10.9%	15 11.5%	29 11.2%

Outcome Measures

1. Primary Outcome

Title	Composite Success
Description	Composite Success is defined as 2-grade improvement on both Clinician Erythema Assessment (CEA) and Patient Self Assessment(PSA).
Time Frame	Day 29

Outcome Measure Data

Analysis Population Description

Intent-to-Treat (ITT) population (i.e. Hours 3,6,9,12)

Arm/Group Title	CD07805/47 Gel	Placebo
Arm/Group Description
Measure Participants	127	128
Day 29 / Hour 3	40 31%	14 10.7%
Day 29 / Hour 6	39 30.2%	12 9.2%
Day 29 / Hour 9	33 25.6%	13 9.9%
Day 29 / Hour 12	29 22.5%	11 8.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CD07805/47 Gel, Placebo
	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.

Adverse Events

Arm/Group Title	CD07805/47 Gel		Placebo
Arm/Group Description
All Cause Mortality
	CD07805/47 Gel		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	CD07805/47 Gel		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/129 (0.8%)		0/131 (0%)
Injury, poisoning and procedural complications
Accidental drug intake by child	1/129 (0.8%)	1	0/131 (0%)	0
Other (Not Including Serious) Adverse Events
	CD07805/47 Gel		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/129 (0%)		0/131 (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.