Title

Phase 3 Efficacy and Safety Study of CD07805/47 Topical Gel in Subjects With Facial Erythema Associated With Rosacea
A Multicenter, Randomized Double-Blind, Vehicle-Controlled, Parallel Group Study to Demonstrate the Efficacy and Safety of CD07805/47 Gel Applied Topically Once Daily in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea
  • Phase

    Phase 3
  • Study Type

    Interventional
  • Intervention/Treatment

    cd07805/47 ...
  • Study Participants

    260
Phase 3 efficacy and safety study of CD07805/47 topical gel in subjects with facial erythema associated with rosacea. The study hypothesis is that CD07805/47 gel, applied topically once daily is more efficacious than vehicle and provides an acceptable safety profile in the treatment of facial erythema associated with rosacea.
Study Started
May 31
2011
Primary Completion
Sep 30
2011
Study Completion
Dec 31
2011
Results Posted
Nov 21
2013
Estimate
Last Update
Feb 18
2021

Drug CD07805/47 gel

applied topically once daily

Drug Placebo

applied topically once daily

CD07805/47 gel Experimental

Placebo Placebo Comparator

Criteria

Key Inclusion Criteria:

Male or female who is at least 18 years of age or older.
A clinical diagnosis of facial rosacea.
A Clinician Erythema Assessment (CEA) score of greater than or equal to 3 at Screening and at Baseline/Day 1 (prior to the study drug application).
A Patient Self Assessment (PSA) score of greater than or equal to 3 at Screening and at Baseline/Day 1 (prior to the study drug application).

Key Exclusion Criteria:

Particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin) or other concomitant facial dermatoses that are similar to rosacea such as peri-oral dermatitis, demodicidosis, facial keratosis pilaris, seborrheic dermatitis, acute lupus erythematosus, or actinic telangiectasia.
Presence of three (3) or more facial inflammatory lesions of rosacea.
Current treatment with monoamine oxidase (MAO) inhibitors, barbiturates, opiates, sedatives, systemic anesthetics, or alpha agonists.
Less than 3 months stable dose treatment with tricyclic antidepressants, cardiac glycosides, beta blockers or other antihypertensive agents.
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.

Summary

CD07805/47 Gel

Placebo

All Events

Event Type Organ System Event Term CD07805/47 Gel Placebo

Composite Success

Composite Success is defined as 2-grade improvement on both Clinician Erythema Assessment (CEA) and Patient Self Assessment(PSA).

CD07805/47 Gel

Day 29 / Hour 12

29.0
participants

Day 29 / Hour 3

40.0
participants

Day 29 / Hour 6

39.0
participants

Day 29 / Hour 9

33.0
participants

Placebo

Day 29 / Hour 12

11.0
participants

Day 29 / Hour 3

14.0
participants

Day 29 / Hour 6

12.0
participants

Day 29 / Hour 9

13.0
participants

Total

260
Participants

Age, Continuous

48.8
years (Mean)
Standard Deviation: 12.30

Age, Categorical

Region of Enrollment

Sex: Female, Male

Overall Study

CD07805/47 Gel

Placebo