CompletedPhase 2

Dose Response Study of Patients With Erythematous Rosacea

United States175 participantsStarted 2010-08

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Clinician's Erythema Assessment

Timeframe: Day 28 visit

Trial details

NCT IDNCT01186068

SponsorVicept Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

View on ClinicalTrials.gov More Erythematous (Type One) Rosacea trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.