Dose Response Study of Patients With Erythematous Rosacea

Vicept Therapeutics

Status and phase: Completed; Phase 2

Conditions: Erythematous (Type One) Rosacea

Treatments: Other: vehicle; Drug: V-101

Study type: Interventional

Funder types: Industry

Identifiers

NCT01186068

V-101-ROSE-202

Details and patient eligibility

About

The purpose of this study is to evaluate the dose-response relationship (effect) of four concentrations of V-101 Cream in patients with erythematous(redness) rosacea.

Full description

Patients must have moderate to severe erythematous (facial redness) rosacea

• Male and female patients must be at least 18 years old and in good general health
• Female patients must not be pregnant or nursing

Enrollment: 175 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• male or females at least 18 years of age
• diagnosis of stable erythematous rosacea
• < 3 inflammatory lesions
• in good general health
• females must be non-pregnant and non-lactating
• must be willing to sign a consent form

Exclusion criteria

• have ocular, phymatous or other types of rosacea
• allergy to any ingredient in study drug
• participation in other investigational studies within 30 days of enrollment
• use of systemic steroids within 28 days of Baseline
• use of tetracycline antibiotics within 28 days of baseline
• use of products containing oxymetazoline within 14 days of baseline
• use of topical steroids witin treatment area 14 days prior to baseline
• use of Rx or OTC products for treatment of acne or rosacea within 14 days of baseline
• use of any product for reducing redness within the treatment area witin 14 days prior to baseline
• use of monoamine oxidase (MAO) inhibitors
• use of niacin >/= 500mg/day

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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175 participants in 5 patient groups, including a placebo group

V-101 Cream 0.01% Concentration

Experimental group

Description:

Low dose

Treatment:

Drug: V-101

V-101 Cream 0.06% Concentration

Experimental group

Description:

Mid-dose

Treatment:

Drug: V-101

V-101 Cream 0.1% Concentration

Experimental group

Description:

Mid-dose

Treatment:

Drug: V-101

V-101 Cream 0.15% Concentration

Experimental group

Description:

High dose

Treatment:

Drug: V-101

Vehicle

Placebo Comparator group

Description:

Cream without an active ingredient

Treatment:

Other: vehicle