Back to resultsEfficacy and Safety Study Comparing CD07805/47 Gel 0.5% to Azelaic Acid Gel 15% in Subjects With Erythema of Rosacea
Primary Purpose
Erythema, Rosacea
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
CD07805/47 gel 0.5%/CD07805/47 Vehicle
azelaic acid gel 15%
Sponsored by
About this trial
This is an interventional treatment trial for Erythema
Eligibility Criteria
Inclusion Criteria:
- Subject is male or female aged 18 years or older.
- Subject has a clinical diagnosis of facial rosacea.
- Subject has a clinician's assessment score of moderate to severe erythema prior to enrollment.
- Subject has a self assessment score of moderate to severe redness prior to enrollment.
- Subjects with none to mild facial inflammatory lesions of rosacea prior to enrollment.
Exclusion Criteria:
- Female subjects who are pregnant, nursing or planning a pregnancy during the study.
- Subjects with a condition or who are in a situation, which in the Investigator's opinion may put a subject at risk, may confound study results, or may interfere with a subject's participation in the study.
- Subjects with conditions causing facial erythema which would confound the assessment of treatment.
- Subjects who are taking or have recently taken medications known to have interactions with α2-adrenergic agonists.
- Subjects with known allergies or sensitivities to one of the components of the investigational products.
Sites / Locations
- Hudson Dermatology
- Dermatology Specialists Research, LLC
- DermResearch, Inc
- The Education & Research Foundation, Inc.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Overall Study
Arm Description
In this crossover study of CD07805/47 gel 0.5%/CD07805/47 Vehicle and azelaic acid gel 15%, 70 subjects were randomly assigned to treatment sequence. During Period 1 (15 days), 35 subjects received topical CD07805/47 gel 0.5% in the morning and topical CD07805/47 gel vehicle in the evening, and 35 received topical azelaic acid gel twice daily according to FDA approved prescribing information. Subjects crossed over to the other treatment in Period 2 (15 days).
Outcomes
Primary Outcome Measures
Composite Success
Composite Success, defined as a 2-grade improvement at 6 hours on both the clinician's and subject's erythema assessments at the end of each treatment period
Secondary Outcome Measures
Onset of Action
Onset of action, defined as an improvement on both the clinician's and subject's erythema assessments at 30 minutes post baseline application
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01659853
Brief Title
Efficacy and Safety Study Comparing CD07805/47 Gel 0.5% to Azelaic Acid Gel 15% in Subjects With Erythema of Rosacea
Official Title
A Multicenter, Randomized, Controlled, Double-masked, Crossover Design Study to Compare Efficacy and Assess Safety of CD07805/47 Gel 0.5% Applied Once Daily vs Azelaic Acid Gel 15% Applied Twice Daily in Subjects With Erythema of Rosacea
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galderma R&D
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare the efficacy and assess the safety of CD07805/47 gel 0.5% applied topically once daily versus azelaic acid gel 15% applied topically twice daily in subjects with moderate to severe facial erythema of rosacea.
Detailed Description
Adult subjects with moderate to severe facial erythema of rosacea who meet inclusion/exclusion criteria will be randomized at Baseline/Visit 1 in a 1:1 ratio to receive either CD07805/47 gel 0.5% once daily or azelaic acid gel 15% twice daily for 15 days. Following an appropriate washout period, subjects will then switch treatments and use the second investigational product as instructed for 15 days (according to the subject's randomization scheme). Subjects will re-qualify based upon inclusion/exclusion prior to Period 2 treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erythema, Rosacea
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Overall Study
Arm Type
Experimental
Arm Description
In this crossover study of CD07805/47 gel 0.5%/CD07805/47 Vehicle and azelaic acid gel 15%, 70 subjects were randomly assigned to treatment sequence.
During Period 1 (15 days), 35 subjects received topical CD07805/47 gel 0.5% in the morning and topical CD07805/47 gel vehicle in the evening, and 35 received topical azelaic acid gel twice daily according to FDA approved prescribing information. Subjects crossed over to the other treatment in Period 2 (15 days).
Intervention Type
Drug
Intervention Name(s)
CD07805/47 gel 0.5%/CD07805/47 Vehicle
Other Intervention Name(s)
brimonidine tartrate gel 0.5%, brimonidine tartrate gel vehicle
Intervention Description
To maintain masking, CD07805/47 gel 0.5% will be administered along with CD07805/47 gel vehicle.
During each treatment period (baseline to Day 15):
CD07805/47 gel 0.5%, topical, once daily and CD07805/47 gel vehicle, topical, once daily
Intervention Type
Drug
Intervention Name(s)
azelaic acid gel 15%
Other Intervention Name(s)
Finacea® gel 15%
Intervention Description
During each treatment period (baseline to Day 15): azelaic acid gel 15%, topical, twice daily
Primary Outcome Measure Information:
Title
Composite Success
Description
Composite Success, defined as a 2-grade improvement at 6 hours on both the clinician's and subject's erythema assessments at the end of each treatment period
Time Frame
Hour 6 on Day 15
Secondary Outcome Measure Information:
Title
Onset of Action
Description
Onset of action, defined as an improvement on both the clinician's and subject's erythema assessments at 30 minutes post baseline application
Time Frame
30 minutes after baseline treatment application on Day 15
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject is male or female aged 18 years or older.
Subject has a clinical diagnosis of facial rosacea.
Subject has a clinician's assessment score of moderate to severe erythema prior to enrollment.
Subject has a self assessment score of moderate to severe redness prior to enrollment.
Subjects with none to mild facial inflammatory lesions of rosacea prior to enrollment.
Exclusion Criteria:
Female subjects who are pregnant, nursing or planning a pregnancy during the study.
Subjects with a condition or who are in a situation, which in the Investigator's opinion may put a subject at risk, may confound study results, or may interfere with a subject's participation in the study.
Subjects with conditions causing facial erythema which would confound the assessment of treatment.
Subjects who are taking or have recently taken medications known to have interactions with α2-adrenergic agonists.
Subjects with known allergies or sensitivities to one of the components of the investigational products.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald W. Gottschalk, MD
Organizational Affiliation
Galderma R&D
Official's Role
Study Director
Facility Information:
Facility Name
Hudson Dermatology
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Dermatology Specialists Research, LLC
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
DermResearch, Inc
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
The Education & Research Foundation, Inc.
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety Study Comparing CD07805/47 Gel 0.5% to Azelaic Acid Gel 15% in Subjects With Erythema of Rosacea
We'll reach out to this number within 24 hrs