Evaluation of the New Laser PHOTOLASE PLV-585nm for the Treatment of Rosacea (NCT03708263) | Clinical Trial Compass
TerminatedNot Applicable
Evaluation of the New Laser PHOTOLASE PLV-585nm for the Treatment of Rosacea
Stopped: departure of Pr MORDON from the ONCOTHAI unit
France1 participantsStarted 2020-09-08
Plain-language summary
Rosacea is a frequent dermatological condition, with a chronic and disturbing evolution that is characterized by redness, permanent erythema associated with telangiectasia (visible and permanent dilatation of the small vessels). It frequently affects men and women with fair skin and can have significant psycho-emotional consequences.
To counteract the unaesthetic appearance of redness and eliminate telangiectasia, the use of the laser is proposed to the patient.
This study is a single center prospective, randomized, controlled split face study to compare 532nm KTP laser versus 585 nm PLV Laser in terms of improvement of the symptoms in the treatment of Erythematotelangiectatic Rosacea 20 subjects will receive up to 3 laser treatments at day 0, month 2 and 4 and will be followed at month 6 and 12.
Who can participate
Age range
18 Years – 65 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:
* Fitzpatrick Skin Type I - III
* Post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrolment and during the entire course of the study.
* Clinical diagnosis of Erythematotelangiectatic Rosacea stade II
* Homogeneous extend and staining telangiectasia in each half face
* Patient never treated with laser for Rosacea
* Patient doesn't wish to use systemic corticosteroids or retinoids; or topical corticosteroids or retinoids on the treated area.
* Patient agreeing to have limited exposure to the sun and use of a protective screen (index 50 or higher) every day of the study and throughout its duration if it takes place from May to September.
* Patient must be able to read, understand and sign the Informed Consent Form
* Patient able to adhere to the program of visits of the study and the other imperatives of the protocol
* Patient accepting to have photographs taken on the face
* Quality of social insurance or social security entitlement
Exclusion Criteria:
* Pregnant and/or breastfeeding woman or childbearing age without effective contraception
* Alcohol abuse assessed at the discretion of the investigator
* History of prior laser or light based procedures for any other pathology for the face within 6 months of study participation Fitzpatrick Type IV à VI
* Systemic use of isotretinoin in the 6 months prior to inclusion in the study.
* Topical use of retinoids and / or corticosteroids…
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
Degree of improvement in Erythematotelangiectatic Rosacea