CompletedPhase 4

Patient Centered Outcomes in Rosacea: An Exploratory Multi-media Analysis of the Patient Experience on Oracea

United States24 participantsStarted 2013-03

Plain-language summary

The purpose of this study is to characterize rosacea patients', being treated with Oracea, perception through visual analog scale reporting.

Who can participate

Age range

25 Years – 70 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: * Men and women * 25-70 years * Diagnosis of papulopustular rosacea * Eligible for Oracea treatment Exclusion Criteria: * Allergies to components of investigational product and/or hypersensitivity to tetracyclines * Taken systemic therapy directed at improving rosacea, including antibiotics, within 30 days prior to baseline visit * Used topical rosacea treatment within 30 days prior to baseline visit * Have active ocular rosacea and/or blepharitis/meibomianitis requiring systemic treatment by an opthalmologist * Previously failed to have improvement of rosacea with appropriate use of systemic tetracycline family of antibiotics * Exposed to intense/excessive ultraviolet (UV) radiation within one week prior to baseline and/or who forsee unprotected and intense/excessive UV exposure during the course of the study * Have planned surgical procedures during the course of the study * Have used tetracycline antibiotics within 30 days prior to baseline visit or during study * At risk in terms of precautions, warnings, and contraindications

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

Rosacea Score on the Visual Analog Scale

Timeframe: Baseline, Weeks 2, 6, and 12

Trial details

NCT IDNCT01872715

SponsorGalderma R&D

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-06

Results submitted2014-08-12

View on ClinicalTrials.gov More Papulopustular Rosacea trials

Who can participate

Age range

25 Years – 70 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.