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: NCT01318733
• Collaborator: (none)
• Enrollment: 449
• Locations: 27
• Arm: 1
• Duration (Months): 16
• Patients Per Site: 16.6
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

A long-term, open-label, non-comparative safety and efficacy study of CD07805/47 gel 0.5% once daily in subjects with moderate to severe facial erythema associated with rosacea.

Condition or Disease	Intervention/Treatment	Phase
Rosacea	Drug: CD07805/47 gel 0.5%	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 449 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of CD07805/47 Gel 0.5% Applied Topically Once Daily for up to 52 Weeks in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea
• Study Start Date: Mar 1, 2011
• Actual Primary Completion Date: Jun 1, 2012
• Actual Study Completion Date: Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CD07805/47 Gel 0.5%	Drug: CD07805/47 gel 0.5%; In this open-label study, all subjects will receive treatment with CD07805/47 gel 0.5% applied once daily, for up to 12 months.

Outcome Measures

Primary Outcome Measures

1. Long Term Safety & Efficacy of CD07805/47 Gel 0.5% in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea. [Over 1 year]

   Static evaluation of erythema severity using the Clinician Erythema Assessment (CEA) - Grade/Description 0 / Clear Skin with no signs of erythema / Almost clear; slight redness / Mild erythema; definite redness / Moderate erythema; marked redness / Severe erythema; fiery redness Change in CEA from Baseline CEA (T0 at Baseline visit Day 1) at T3 of each post-baseline visit, including Day 1.

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 facial rosacea.

• A Clinician Erythema Assessment (CEA) score of ≥3 at Screening and at Baseline (prior to study drug application).

• A Patient Self Assessment (PSA) score of ≥3 at Screening and at Baseline (prior to study drug application).

Exclusion Criteria:

• 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.

• 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.

• Previous refractive eye surgery such as photorefractive keratectomy (PRK), laser-assisted sub-epithelial keratectomy (LASEK), or laser-assisted in situ keratomileusis (LASIK).

• Current treatment with monoamine oxidase (MAO) inhibitors.

• Current treatment with barbiturates, opiates, sedatives, systemic anesthetics, or alpha-agonists.

• Less than 3 months stable dose treatment with tricyclic anti-depressants, cardiac glycosides, beta blockers or other antihypertensive agents.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Laser Institute for Dermatology	Santa Monica	California	United States	90404
2	Cherry Creek Research, Inc	Denver	Colorado	United States	80209
3	Longmont Clinical PC	Longmont	Colorado	United States	80501
4	Gwinnett Clinical Research Center, Inc	Snellville	Georgia	United States	30078
5	Deaconess Clinic	Evansville	Indiana	United States	47713
6	Compliant Clinical Research	Olathe	Kansas	United States	66061
7	Hamzavi Dermatology	Fort Gratiot	Michigan	United States	48059
8	Dermcenter PC- Somerset Skin Centre	Troy	Michigan	United States	48084
9	Minnesota Clinical Study Center	Fridley	Minnesota	United States	55432
10	Skin Specialists, PC	Omaha	Nebraska	United States	68144
11	DermResearch Center of New York, Inc	Stony Brook	New York	United States	11790
12	Metrolina Medical Research	Charlotte	North Carolina	United States	27277
13	Dermatology, Laser & Vein Specialists of the Carolinas	Charlotte	North Carolina	United States	28207
14	Wilmington Medical Research	Wilmington	North Carolina	United States	28401
15	Piedmont Medical Research	Winston-Salem	North Carolina	United States	27103
16	DermDox	Hazleton	Pennsylvania	United States	18201
17	Palmetto Medical Research	Mount Pleasant	South Carolina	United States	29464
18	Rivergate Dermatology Clinical Research Center, PLLC	Goodlettsville	Tennessee	United States	37072
19	East Tennessee Medical Research	Johnson City	Tennessee	United States	37604
20	TriCities Medical Research	Kingsport	Tennessee	United States	37660
21	Tennessee Clinical Research Center	Nashville	Tennessee	United States	37215
22	Arlington Center for Dermatology	Arlington	Texas	United States	76011
23	Dermatology Clinical Research Center of San Antonio	San Antonio	Texas	United States	78229
24	Progressive Clinical Research, PA	San Antonio	Texas	United States	78229
25	Dermatology Research Center	Salt Lake City	Utah	United States	84124
26	Wenatchee Valley Medical Center - Clinical Research Department	Wenatchee	Washington	United States	98801
27	Madison Skin & Research, Inc.	Madison	Wisconsin	United States	53719

Sponsors and Collaborators

• Galderma R&D

Investigators

• Principal Investigator: Scott Clark, MD, Longmont Clinical PC
• Principal Investigator: Lesly Davidson, MD, Palmetto Medical Research
• Principal Investigator: Steven Davis, MD, Dermatology Clinical Research Center of San Antonio
• Principal Investigator: Michael Donahue, MD, Wilmington Medical Research
• Principal Investigator: Timothy Gardner, MD, East Tennessee Medical Research
• Principal Investigator: Michael Gold, MD, Tennessee Clinical Research Center
• Principal Investigator: Fasahat Hamzavi, MD, Hamzavi Dermatology
• Principal Investigator: Mark Lee, MD, Progressive Clinicial Research, PA
• Principal Investigator: Debra Liu, MD, Piedmont Medical Research
• Principal Investigator: Keith Loven, MD, Rivergate Dermatology Clinical Research Center, PLLC
• Principal Investigator: Michael Maloney, MD, Cherry Creek Research, Inc.
• Principal Investigator: Angela Moore, MD, Arlington Center for Dermatology
• Principal Investigator: George Murakawa, MD, Dermcenter PC - Somerset Skin Centre
• Principal Investigator: Catherine Pointon, MD, Metrolina Medical Research
• Principal Investigator: Elyse Rafal, MD, DermResearch Center of NewYork, Inc.
• Principal Investigator: Stephen Schleicher, MD, DermDox
• Principal Investigator: Joel Schlessinger, MD, Skin Specialists, PC
• Principal Investigator: Leonard Swinyer, MD, Dermatology Research Center
• Principal Investigator: Amanda Tauscher, MD, Compliant Clinical Research
• Principal Investigator: Gary Waterman, MD, Deaconess Clinic
• Principal Investigator: Jonathan Weiss, MD, Gwinnett Clinical Research Center, Inc.
• Principal Investigator: Morrissa Baskin, MD, Wenatchee Valley Medical Center, Clinical Research Department
• Principal Investigator: Steven Kempers, MD, Minnesota Clinical Study Center
• Principal Investigator: Ava Shamban, MD, The Laser Institute for Dermatology
• Principal Investigator: Harry Sharata, MD, Madison Skin & Research, Inc.
• Principal Investigator: Russell Mader, MD, TriCities Medical Research
• Principal Investigator: Girish Munavalli, MD, Dermatology, Laser & Vein Specialists of the Carolinas

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Galderma R&D
• ClinicalTrials.gov Identifier: NCT01318733
• Other Study ID Numbers: RD.06.SPR.18142
• First Posted: Mar 18, 2011
• Last Update Posted: Feb 18, 2021
• Last Verified: Mar 1, 2014

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

Study Results

Participant Flow

Arm/Group Title	CD07805/47 Gel 0.5%
Arm/Group Description	CD07805/47 Gel 0.5% once daily
Period Title: Overall Study
STARTED	449
COMPLETED	279
NOT COMPLETED	170

Baseline Characteristics

Arm/Group Title	CD07805/47 Gel 0.5%
Arm/Group Description	CD07805/47 Gel 0.5% once daily
Overall Participants	449
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	395 88%
>=65 years	54 12%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	50.9 (12.08)
Sex: Female, Male (Count of Participants)
Female	336 74.8%
Male	113 25.2%
Region of Enrollment (participants) [Number]
United States	449 100%

Outcome Measures

1. Primary Outcome

Title	Long Term Safety & Efficacy of CD07805/47 Gel 0.5% in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea.
Description	Static evaluation of erythema severity using the Clinician Erythema Assessment (CEA) - Grade/Description 0 / Clear Skin with no signs of erythema / Almost clear; slight redness / Mild erythema; definite redness / Moderate erythema; marked redness / Severe erythema; fiery redness Change in CEA from Baseline CEA (T0 at Baseline visit Day 1) at T3 of each post-baseline visit, including Day 1.
Time Frame	Over 1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CD07805/47 Gel 0.5% QD
Arm/Group Description
Measure Participants	449
Day 1 / Hour 3	-1.5 (.88)
Week 1/ Hour 3	-1.4 (.85)
Month 1/ Hour 3	-1.5 (.83)
Month 3 / Hour 3	-1.7 (.84)
Month 6 / Hour 3	-1.8 (.88)
Month 9 / Hour 3	-1.7 (.9)
Month 12 / Hour 3	-1.8 (.83)

Adverse Events

Arm/Group Title	CD07805/47 Gel 0.5%
Arm/Group Description
All Cause Mortality
	CD07805/47 Gel 0.5%
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	CD07805/47 Gel 0.5%
	Affected / at Risk (%)	# Events
Total	12/449 (2.7%)
Cardiac disorders
Unstable Angina	1/449 (0.2%)	1
Sustained Ventricular Tachycardia	1/449 (0.2%)	1
Gastrointestinal disorders
Distal Esophageal Schatzki's Ring	1/449 (0.2%)	1
Infections and infestations
Abscess tooth w/ secondary submandibular infection	1/449 (0.2%)	1
Atypical Pneumonia	1/449 (0.2%)	1
Sepsis	1/449 (0.2%)	1
Injury, poisoning and procedural complications
Bilateral Achilles Tendon ruptures	1/449 (0.2%)	1
Musculoskeletal and connective tissue disorders
Osteoarthritis of left hip	1/449 (0.2%)	1
Synovitis Right Ankle	1/449 (0.2%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Advanced squamous cell carcinoma of the lung	1/449 (0.2%)	1
Invasive ductal carcinoma	1/449 (0.2%)	1
Nervous system disorders
Encephalopathy	1/449 (0.2%)	1
Reproductive system and breast disorders
Right Ovarian Cyst	1/449 (0.2%)	1
Persistent Abnormal Uterine Bleeding	1/449 (0.2%)	1
Respiratory, thoracic and mediastinal disorders
COPD	1/449 (0.2%)	1
Hypoxia	1/449 (0.2%)	1
Other (Not Including Serious) Adverse Events
	CD07805/47 Gel 0.5%
	Affected / at Risk (%)	# Events
Total	101/449 (22.5%)
Skin and subcutaneous tissue disorders
Erythema	35/449 (7.8%)
Rosacea	24/449 (5.3%)
Vascular disorders
Flushing	46/449 (10.2%)

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.