Isotretinoin in Papular-Pustular Rosacea (NCT00882531) | Clinical Trial Compass
CompletedPhase 3
Isotretinoin in Papular-Pustular Rosacea
156 participantsStarted 2007-02
Plain-language summary
A national, multicentre, prospective, randomised, double-blind, phase III study in 2 parallel groups of isotretinoin versus placebo in patients presenting papular-pustular rosacea resistant to standard therapy. A non-balanced group (2 isotretinoin /1 placebo) design was selected since, given the nature of the study disease, fewer patients will receive the placebo than active isotretinoin.
Treatment duration for each patient : 4 months, with monthly evaluation Follow-up at 2 months and 4 months for patients responsive after 4 months of treatment.
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:
* Adult
* Patients presenting papular-pustular rosacea (characterised by at least 8 lesions (papules and/or pustules)
* resistant for at least 3 months in the last two years to standard treatment comprising systemic antibiotics (cyclins) with or without topical therapy
* Full compliance with a two-week wash-out period for all other topical and systemic treatments for rosacea at the time of selection
* For women of childbearing age, use of a minimum of one "effective" contraceptive method for at least one month and willingness to continue using an effective contraceptive method continuously throughout the study duration and for at least one month after the end of treatment.
* Women of childbearing age must provide consent for pregnancy testing before the start of treatment, monthly throughout treatment and 5 weeks after the end of treatment.
* Negative pregnancy test results from within the last 3 days (for female subjects of childbearing age)
* No laboratory abnormalities in standard tests
* Social Security medical cover
* Provision of written and dated informed consent to take part in the study
Exclusion Criteria:
* Patients already receiving isotretinoin for rosacea or within the last 12 months for acne
* Patients presenting perioral dermatitis
* Patients presenting miliary lupoid
* Patients presenting cortisone-induced rosacea
* Pregnant or breast-feeding women
* Patients with repeated and habitual heavy physical activity
* Patients with known hepati…
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
1
To determine numbers of patients responding to treatment for 4 months with isotretinoin (patients were considered as responders if their number of papular-pustular lesions fell by at least 90% after 4 months of treatment)