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

Galderma

Status and phase: Completed; Phase 2

Conditions: Rosacea

Treatments: Drug: Vehicle Gel; Drug: CD07805/47 Gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT01174030

RD.06.SPR.18161

Details and patient eligibility

About

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.

Enrollment: 269 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 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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269 participants in 5 patient groups, including a placebo group

CD07805/47 Gel 0.5% QD

Experimental group

Treatment:

Drug: CD07805/47 Gel

Drug: CD07805/47 Gel

Drug: CD07805/47 Gel

CD07805/47 Gel 0.18% QD

Experimental group

Treatment:

Drug: CD07805/47 Gel

Drug: CD07805/47 Gel

Drug: CD07805/47 Gel

CD07805/47 Gel 0.18% BID

Experimental group

Treatment:

Drug: CD07805/47 Gel

Drug: CD07805/47 Gel

Drug: CD07805/47 Gel

Vehicle Gel QD

Placebo Comparator group

Treatment:

Drug: Vehicle Gel

Drug: Vehicle Gel

Vehicle Gel BID

Placebo Comparator group

Treatment:

Drug: Vehicle Gel

Drug: Vehicle Gel