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: NCT01355471
• Collaborator: (none)
• Enrollment: 293
• Locations: 15
• Arms: 2
• Duration (Months): 8
• Patients Per Site: 19.5
• Patients Per Site Per Month: 2.4

Study Details

Study Description

Brief Summary

This is a 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: 293 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: Nov 1, 2011
• Actual Study Completion Date: Jan 1, 2012

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	Burke Pharmaceutical Research	Hot Springs	Arkansas	United States	71913
2	Baumann Cosmetic and Research Institute	Miami Beach	Florida	United States	33140
3	MedaPhase, Inc.	Newnan	Georgia	United States	30263
4	Dermatology Specialists Research	Louisville	Kentucky	United States	40202
5	Grekin Skin Institute	Warren	Michigan	United States	48088
6	Central Dermatology PC	Saint Louis	Missouri	United States	63117
7	Skin Specialty Dermatology	New York	New York	United States	10155
8	Haber Dermatology & Cosmetic Surgery	South Euclid	Ohio	United States	44118
9	Oregon Dermatology and Research Center	Portland	Oregon	United States	97210
10	Palmetto Clinical Trial Services, LLC	Greenville	South Carolina	United States	29607
11	J&S Studies Inc.	College Station	Texas	United States	77845
12	Premier Clinical Research	Spokane	Washington	United States	99201
13	Kirk Barber Research Inc.	Calgary	Alberta	Canada	T25 3B3
14	Nexus Clinical Research	St John's	Newfoundland and Labrador	Canada	A1A 5E8
15	Newlab Clinical Research Inc.	St. John's	Newfoundland and Labrador	Canada	A1C2H5

Sponsors and Collaborators

• Galderma R&D

Investigators

• Study Chair: Michael Graeber, MD, Galderma R&D
• Principal Investigator: Kirk Barber, MD, Kirk Barber Research Inc.
• Principal Investigator: Leslie Baumann, MD, Baumann Cosmetic and Research Institute
• Principal Investigator: Fran Cook-Bolden, MD, Skin Specialty Dermatology
• Principal Investigator: Joseph Fowler, MD, Dermatology Specialists PSC
• Principal Investigator: Steven Grekin, DO, Grekin Skin Institute
• Principal Investigator: Wayne Gulliver, MD, Newlab Clinical Research Inc.
• Principal Investigator: Robert Haber, MD, Haber Dermatology & Cosmetic Surgery
• Principal Investigator: Michael Heffernan, MD, Central Dermatology
• Principal Investigator: Terry Jones, MD, J&S Studies Inc.
• Principal Investigator: Ian Landells, MD, Nexus Clinical Research
• Principal Investigator: Mark Ling, MD, MedaPhase, Inc.
• Principal Investigator: Phoebe Rich, MD, Oregon Dermatology and Research Center
• Principal Investigator: Dow Stough, MD, Burke Pharmaceutical Research
• Principal Investigator: William Werschler, MD, Premier Clinical Research
• Principal Investigator: Patricia Westmoreland, MD, Palmetto Clinical Trials Services, LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Galderma R&D
• ClinicalTrials.gov Identifier: NCT01355471
• Other Study ID Numbers: RD.06.SPR.18141
• 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	148	145
COMPLETED	141	142
NOT COMPLETED	7	3

Baseline Characteristics

Arm/Group Title	CD07805/47 Gel	Placebo	Total
Arm/Group Description	Total of all reporting groups
Overall Participants	148	145	293
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	136 91.9%	134 92.4%	270 92.2%
>=65 years	12 8.1%	11 7.6%	23 7.8%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	48.5 (11.94)	46.5 (12.10)	47.5 (12.04)
Sex: Female, Male (Count of Participants)
Female	105 70.9%	108 74.5%	213 72.7%
Male	43 29.1%	37 25.5%	80 27.3%
Region of Enrollment (participants) [Number]
United States	140 94.6%	138 95.2%	278 94.9%
Canada	8 5.4%	7 4.8%	15 5.1%

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	142	142
Day 29/ Hour 3	36 24.3%	13 9%
Day 29 / Hour 6	36 24.3%	13 9%
Day 29 / Hour 9	25 16.9%	15 10.3%
Day 29 / Hour 12	30 20.3%	14 9.7%

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 Estimation 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	1/148 (0.7%)		0/145 (0%)
Infections and infestations
Appendicitis	1/148 (0.7%)	1	0/145 (0%)	0
Other (Not Including Serious) Adverse Events
	CD07805/47 Gel		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/148 (0%)		0/145 (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.