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Completed

NCT Number: NCT01659853

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hudson Dermatology, Evansville, Indiana, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CD07805/47 gel 0.5%/CD07805/47 Vehicle

Drug

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

azelaic acid gel 15%

Drug

During each treatment period (baseline to Day 15): azelaic acid gel 15%, topical, twice daily

Other names: Finacea® gel 15%

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Aug 8, 2012
Registry last updated
Aug 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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