Title

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

    Phase 2
  • Study Type

    Interventional
  • Intervention/Treatment

    cd07805/47 ...
  • Study Participants

    269
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.
Study Started
Aug 31
2010
Primary Completion
Dec 31
2010
Study Completion
Jan 31
2011
Results Posted
Mar 11
2014
Estimate
Last Update
Feb 26
2021

Drug CD07805/47 Gel

CD07805/47 Gel 0.5% QD

Drug Vehicle Gel

Vehicle Gel QD

Drug CD07805/47 Gel

CD07805/47 Gel 0.18% QD

Drug CD07805/47 Gel

CD07805/47 Gel 0.18% BID

Drug Vehicle Gel

Vehicle Gel BID

CD07805/47 Gel 0.5% QD Experimental

CD07805/47 Gel 0.18% QD Experimental

CD07805/47 Gel 0.18% BID Experimental

Vehicle Gel QD Placebo Comparator

Vehicle Gel BID Placebo Comparator

Criteria

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.

Summary

CD07805/47 Gel 0.5% QD

CD07805/47 Gel 0.18% QD

CD07805/47 Gel 0.18% BID

Vehicle Gel QD

Vehicle Gel BID

All Events

Event Type Organ System Event Term CD07805/47 Gel 0.5% QD CD07805/47 Gel 0.18% QD CD07805/47 Gel 0.18% BID Vehicle Gel QD Vehicle Gel BID

Composite Success

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.

CD07805/47 Gel 0.5% QD

Day 29/Hour 12

10.0
participants

Day 29/Hour 3

16.0
participants

Day 29/Hour 6

15.0
participants

Day 29/Hour 9

17.0
participants

CD07805/47 Gel 0.18% QD

Day 29/Hour 12

5.0
participants

Day 29/Hour 3

10.0
participants

Day 29/Hour 6

10.0
participants

Day 29/Hour 9

7.0
participants

CD07805/47 Gel 0.18% BID

Day 29/Hour 12

8.0
participants

Day 29/Hour 3

10.0
participants

Day 29/Hour 6

9.0
participants

Day 29/Hour 9

11.0
participants

Vehicle Gel QD

Day 29/Hour 12

2.0
participants

Day 29/Hour 3

2.0
participants

Day 29/Hour 6

4.0
participants

Day 29/Hour 9

2.0
participants

Vehicle Gel BID

Day 29/Hour 12

9.0
participants

Day 29/Hour 3

4.0
participants

Day 29/Hour 6

7.0
participants

Day 29/Hour 9

10.0
participants

CEA Success

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

CD07805/47 Gel 0.5% QD

Day 29/Hour 12

20.0
participants

Day 29/Hour 3

27.0
participants

Day 29/Hour 6

23.0
participants

Day 29/Hour 9

26.0
participants

CD07805/47 Gel 0.18% QD

Day 29/Hour 12

17.0
participants

Day 29/Hour 3

21.0
participants

Day 29/Hour 6

21.0
participants

Day 29/Hour 9

20.0
participants

CD07805/47 Gel 0.18% BID

Day 29/Hour 12

18.0
participants

Day 29/Hour 3

22.0
participants

Day 29/Hour 6

18.0
participants

Day 29/Hour 9

23.0
participants

Vehicle Gel QD

Day 29/Hour 12

12.0
participants

Day 29/Hour 3

12.0
participants

Day 29/Hour 6

12.0
participants

Day 29/Hour 9

12.0
participants

Vehicle Gel BID

Day 29/Hour 12

16.0
participants

Day 29/Hour 3

9.0
participants

Day 29/Hour 6

12.0
participants

Day 29/Hour 9

15.0
participants

PSA-5 Success

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

CD07805/47 Gel 0.5% QD

Day 29/Hour 12

20.0
participants

Day 29/Hour 3

25.0
participants

Day 29/Hour 6

26.0
participants

Day 29/Hour 9

22.0
participants

CD07805/47 Gel 0.18% QD

Day 29/Hour 12

9.0
participants

Day 29/Hour 3

17.0
participants

Day 29/Hour 6

13.0
participants

Day 29/Hour 9

9.0
participants

CD07805/47 Gel 0.18% BID

Day 29/Hour 12

16.0
participants

Day 29/Hour 3

20.0
participants

Day 29/Hour 6

15.0
participants

Day 29/Hour 9

19.0
participants

Vehicle Gel QD

Day 29/Hour 12

5.0
participants

Day 29/Hour 3

7.0
participants

Day 29/Hour 6

8.0
participants

Day 29/Hour 9

5.0
participants

Vehicle Gel BID

Day 29/Hour 12

10.0
participants

Day 29/Hour 3

11.0
participants

Day 29/Hour 6

11.0
participants

Day 29/Hour 9

13.0
participants

Total

269
Participants

Age, Continuous

44.3
years (Mean)
Standard Deviation: 12.32

Age, Categorical

Region of Enrollment

Sex: Female, Male

Overall Study

CD07805/47 Gel 0.5% QD

CD07805/47 Gel 0.18% QD

CD07805/47 Gel 0.18% BID

Vehicle Gel QD

Vehicle Gel BID