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Completed

NCT Number: NCT01174030

Efficacy and Safety Study of CD07805/47 Topical Gel in Subjects With Facial Erythema Associated With Rosacea

The purpose of this vehicle controlled study is to evaluate the efficacy and safety of CD07805/47 gel 0.5% applied topically once daily (QD) for 4 weeks, and CD07805/47 gel 0.18% applied topically once daily (QD) or twice daily (BID) for 4 weeks, in subjects with moderate to severe facial erythema associated with rosacea.

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Key information

Conditions

Rosacea Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Burke Pharmaceutical Research, Hot Springs, Arkansas, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female, who is at least 18 years of age or older.
  • A clinical diagnosis of rosacea.
  • A Clinician Erythema Assessment (CEA) score of 3 at Screening and at Pre-dose (T0) on Baseline/Day 1.
  • A Patient Self Assessment-5 (PSA-5) score of 3 at Screening and at Pre-dose (T0) on Baseline/Day 1.
  • A Patient Self Assessment-11 (PSA-11) score of 5 at Screening and at Pre-dose (T0) on Baseline/Day 1.

Exclusion criteria

  • Three (3) or more facial inflammatory lesions.
  • 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.
  • Known allergies or sensitivities to any components of the study medications, including the active gel ingredient, brimonidine tartrate.
  • Intraocular pressure (IOP) measurement less than 10 mm Hg.

Treatment and study plan

CD07805/47 gel

Drug

CD07805/47 Gel 0.5% QD

Vehicle gel

Drug

Vehicle Gel QD

Primary outcomes

  1. Composite Success

    Time frame: Day 29

    Composite success defined as 2-grade improvement on Clinician Erythema Assessment (CEA)and Patient Self Assessment-5 (PSA-5).

    Each concentration/regimen was compared to its respective placebo control as part of the primary analysis.

Secondary outcomes

  1. CEA Success

    Time frame: Day 29

    CEA success defined as 2-grade improvement on CEA.

    Each concentration/regimen was compared to its respective placebo control as part of the primary analysis.

    Clinician Erythema Assessment (CEA) - Grade/Description 0 / Clear Skin with no signs of erythema

    • / Amost clear; slight redness
    • / Mild erythema; definite redness
    • / Moderate erythema; marked redness
    • / Severe erythema; fiery redness

  2. PSA-5 Success

    Time frame: day 29

    Each concentration/regimen was compared to its respective placebo control as part of the primary analysis.

    PSA-5 success defined as 2-grade improvement on PSA-5.

    Patient Self Assessment - 5 (PSA-5) - Grade/description 0 / No redness

    • / Very mild redness
    • / Mild redness
    • / Moderate redness
    • / Severe redness

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study title

A 4-week, Randomized, Double-blind, Parallel-group, Vehicle-controlled, Multicenter Study Investigating the Efficacy and Safety of CD07805/47 Gel 0.5% Applied Topically Once Daily (QD), and CD07805/47 Gel 0.18% Applied Topically Once Daily (QD) or Twice Daily (BID), in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Aug 3, 2010
Registry last updated
Feb 26, 2021

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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