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Efficacy and Safety Study Comparing CD07805/47 Gel 0.5% to Azelaic Acid Gel 15% in Subjects With Erythema of Rosacea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01659853
Recruitment Status : Completed
First Posted : August 8, 2012
Results First Posted : July 10, 2014
Last Update Posted : July 10, 2014
Sponsor:
Information provided by (Responsible Party):
Galderma Laboratories, L.P.

Tracking Information
First Submitted Date  ICMJE August 6, 2012
First Posted Date  ICMJE August 8, 2012
Results First Submitted Date  ICMJE January 15, 2014
Results First Posted Date  ICMJE July 10, 2014
Last Update Posted Date July 10, 2014
Study Start Date  ICMJE September 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 8, 2014)
Composite Success [ Time Frame: Hour 6 on Day 15 ]
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
Original Primary Outcome Measures  ICMJE
 (submitted: August 6, 2012)
Composite Success [ Time Frame: Baseline to Day 15 (15 days) ]
Composite Success, defined as an improvement on both the clinician's and subject's erythema assessments at the end of each treatment period
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2014)
Onset of Action [ Time Frame: 30 minutes after baseline treatment application on Day 15 ]
Onset of action, defined as an improvement on both the clinician's and subject's erythema assessments at 30 minutes post baseline application
Original Secondary Outcome Measures  ICMJE
 (submitted: August 6, 2012)
Onset of Action [ Time Frame: 30 minutes post baseline treatment application ]
Onset of action, defined as an improvement on both the clinician's and subject's erythema assessments at 30 minutes post baseline application
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety Study Comparing CD07805/47 Gel 0.5% to Azelaic Acid Gel 15% in Subjects With Erythema of Rosacea
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Erythema
  • Rosacea
Intervention  ICMJE
  • Drug: CD07805/47 gel 0.5%/CD07805/47 Vehicle

    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

    Other Names:
    • brimonidine tartrate gel 0.5%
    • brimonidine tartrate gel vehicle
  • Drug: azelaic acid gel 15%
    During each treatment period (baseline to Day 15): azelaic acid gel 15%, topical, twice daily
    Other Name: Finacea® gel 15%
Study Arms  ICMJE Experimental: Overall Study

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).

Interventions:
  • Drug: CD07805/47 gel 0.5%/CD07805/47 Vehicle
  • Drug: azelaic acid gel 15%
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 6, 2012)
70
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subject is male or female aged 18 years or older.
  2. Subject has a clinical diagnosis of facial rosacea.
  3. Subject has a clinician's assessment score of moderate to severe erythema prior to enrollment.
  4. Subject has a self assessment score of moderate to severe redness prior to enrollment.
  5. Subjects with none to mild facial inflammatory lesions of rosacea prior to enrollment.

Exclusion Criteria:

  1. Female subjects who are pregnant, nursing or planning a pregnancy during the study.
  2. 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.
  3. Subjects with conditions causing facial erythema which would confound the assessment of treatment.
  4. Subjects who are taking or have recently taken medications known to have interactions with α2-adrenergic agonists.
  5. Subjects with known allergies or sensitivities to one of the components of the investigational products.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01659853
Other Study ID Numbers  ICMJE US10219
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Galderma Laboratories, L.P.
Study Sponsor  ICMJE Galderma Laboratories, L.P.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ronald W. Gottschalk, MD Galderma Laboratories, L.P.
PRS Account Galderma Laboratories, L.P.
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP