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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier:
NCT01659853
First received: August 6, 2012
Last updated: July 8, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Erythema
Rosacea
Drug: CD07805/47 gel 0.5%/CD07805/47 Vehicle
Drug: azelaic acid gel 15%
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Galderma Laboratories, L.P.:

Primary Outcome Measures:
  • Composite Success [ Time Frame: Hour 6 on Day 15 ] [ Designated as safety issue: No ]
    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 [ Time Frame: 30 minutes after baseline treatment application on Day 15 ] [ Designated as safety issue: No ]
    Onset of action, defined as an improvement on both the clinician's and subject's erythema assessments at 30 minutes post baseline application


Enrollment: 70
Study Start Date: September 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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%

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01659853

Locations
United States, Indiana
Hudson Dermatology
Evansville, Indiana, United States, 47714
United States, Kentucky
Dermatology Specialists Research, LLC
Louisville, Kentucky, United States, 40202
United States, Texas
DermResearch, Inc
Austin, Texas, United States, 78759
United States, Virginia
The Education & Research Foundation, Inc.
Lynchburg, Virginia, United States, 24501
Sponsors and Collaborators
Galderma Laboratories, L.P.
Investigators
Study Director: Ronald W. Gottschalk, MD Galderma Laboratories, L.P.
  More Information

No publications provided

Responsible Party: Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier: NCT01659853     History of Changes
Other Study ID Numbers: US10219
Study First Received: August 6, 2012
Results First Received: January 15, 2014
Last Updated: July 8, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Rosacea
Erythema
Skin Diseases
Brimonidine
Azelaic acid
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antineoplastic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on October 02, 2014