Status:
COMPLETED
Dose Response Study of Patients With Erythematous Rosacea
Lead Sponsor:
Vicept Therapeutics, Inc.
Collaborating Sponsors:
Accenture
Conditions:
Erythematous (Type One) Rosacea
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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.
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
175 Patients enrolled
Trial Details
Trial ID
NCT01186068
Start Date
August 1 2010
Last Update
November 24 2010
Active Locations (7)
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1
Therapeutics Clinical Research
San Diego, California, United States, 92123
2
Baumann Cosmetic & Research Institute
Miami Beach, Florida, United States, 33140
3
Dermatology Specialists Research
Louisville, Kentucky, United States, 40202
4
DBA Michigan Center for Skin Care Research
Clinton Twp, Michigan, United States, 48038