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

Galderma

Status and phase

Completed

Phase 3

Conditions

Rosacea

Treatments

Drug: CD07805/47 gel 0.5%

Study type

Interventional

Funder types

Industry

Identifiers

NCT01318733

RD.06.SPR.18142

Details and patient eligibility

About

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.

Enrollment

449 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.