Phase 3
N=449
Study of CD07805/47 Topical Gel in Subjects With Facial Erythema Associated With Rosacea
Rosacea
Bottom Line
View on ClinicalTrials.gov: NCT01318733 ↗Enrolled (actual)
449
Serious AEs
2.7%
Results posted
Jan 2014
Primary outcome: Primary: Long Term Safety & Efficacy of CD07805/47 Gel 0.5% in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea. — -1.5; -1.4; -1.5; -1.7 scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- CD07805/47 gel 0.5% (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Long Term Safety & Efficacy of CD07805/47 Gel 0.5% in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea. |
-1.5; -1.4; -1.5; -1.7; -1.8; -1.7 | — |
Summary
A long-term, open-label, non-comparative safety and efficacy study of CD07805/47 gel 0.5% once daily 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 facial rosacea.
- A Clinician Erythema Assessment (CEA) score of ≥3 at Screening and at Baseline (prior to study drug application).
- A Patient Self Assessment (PSA) score of ≥3 at Screening and at Baseline (prior to study drug application).
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.
- 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.
- Previous refractive eye surgery such as photorefractive keratectomy (PRK), laser-assisted sub-epithelial keratectomy (LASEK), or laser-assisted in situ keratomileusis (LASIK).
- Current treatment with monoamine oxidase (MAO) inhibitors.
- Current treatment with barbiturates, opiates, sedatives, systemic anesthetics, or alpha-agonists.
- Less than 3 months stable dose treatment with tricyclic anti-depressants, cardiac glycosides, beta blockers or other antihypertensive agents.
Data sourced from ClinicalTrials.gov (NCT01318733). 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.