CompletedPhase 1

Combination Therapy for the Treatment of Rosacea

United States6 participantsStarted 2009-07

Plain-language summary

The purpose of this study is to determine the efficacy of calcium dobesilate in combination with pulsed dye laser for the treatment of 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

. Must understand and voluntarily sign an informed consent form.
. Must be male or female and aged ≥ 18 years at time of consent.
. Must be able to adhere to the study visit schedule and other protocol requirements.
. Must have clinically typical confirmed diagnosis of erythematotelangestatic rosacea.
. Females of childbearing potential (FCBP)‡ must have one negative urine pregnancy tests at screening. In addition, sexually active FCBP must agree to use TWO of the following adequate forms of contraception while on study medication: oral, injectable, or implantable hormonal contraceptives; tubal ligation; intrauterine device; barrier contraceptive with spermicide; or vasectomized partner while on the study. A FCBP must agree to have pregnancy tests every 4 weeks while on study medication.
. Males (including those who have had a vasectomy) must agree to use barrier contraception (latex condoms) when engaging in sexual activity with FCBP while on study medication.

Exclusion criteria

. Inability to provide voluntary informed consent.
. Pregnant or breastfeeding female.
. A skin examination reveals the presence of another skin disease and/or condition (excessive facial hair, excessive scarring, sunburn, or other disfigurement) located on the face that would confound the evaluation of the rosacea.

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

Investigator Global Assessment (IGA) scale

Timeframe: one year

Trial details

NCT IDNCT00945373

SponsorEllen Marmur

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-05

View on ClinicalTrials.gov More Erythematotelangiectatic Rosacea trials