Evaluation of the New Laser PHOTOLASE PLV-585nm for the Treatment of Rosacea (ROSAPHOTOLASE)

University Hospital, Lille

Status

Terminated

Conditions

Erythematotelangiectatic Rosacea

Treatments

Device: Excel V 532nm (KTP) green Laser

Device: PHOTOLASE PLV 585 nm yellow laser

Study type

Interventional

Funder types

Other

Identifiers

NCT03708263

2017_57

2018-A01904-51 (Other Identifier)

Details and patient eligibility

About

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.

Full description

Adult male and female subjects 18 years of age or older will participate in the study after the objectives, methods, and potential risks of the study have been explained, and after they have signed the informed consent form.

Patients will come to the investigation center for a maximum of 6 visits.

Enrollment

1 patient

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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 in the 4 weeks prior to inclusion in the study.
Patient under photo sensitization treatment
Patient suffering from significant concurrent illness such as type 1 diabetes, cardiovascular disease, uncontrolled hypertension, neurological disease, lupus erythematosus, scleroderma.
Patient subject to hypertrophic or abnormal scarring
Patient presenting or having a malignant tumor or skin cancer in the area to be treated.
Having a known anticoagulative condition or taking prescription anticoagulation medications.
Participation to another clinical study involving a laser or drug within three months of inclusion in the study.
Smoker or former smoker in the 12 months prior to inclusion in the study.
Patient with excessive tattoos in the area to be treated and / or wishing to tattoo the treated area during the study.
Patient treated for cancer by chemotherapy or radiotherapy
Patient with hyper or hypo pigmentation
Patient unable to understand protocol or give consent
Legal incapacity (persons deprived of their liberty or under guardianship or curatorship)
Patient in emergency or in detention
Clinical follow-up impossible for psychological, family matters, social or geographical reasons