Phase 2
N=269
Efficacy and Safety Study of CD07805/47 Topical Gel in Subjects With Facial Erythema Associated With Rosacea
Rosacea
Bottom Line
View on ClinicalTrials.gov: NCT01174030 ↗Enrolled (actual)
269
Serious AEs
0.7%
Results posted
Mar 2014
Primary outcome: Primary: Composite Success — 16; 10; 10; 2 participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CD07805/47 Gel (Drug); Vehicle Gel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Composite Success |
16; 10; 10; 2; 4; 15 | <0.001 sig |
| SECONDARY CEA Success |
27; 21; 22; 12; 9; 23 | .003 sig |
| SECONDARY PSA-5 Success |
25; 17; 20; 7; 11; 26 | <0.001 sig |
Summary
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01174030). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.