Clinical trial: Evaluation of the New Laser PHOTOLASE PLV-585nm for the Treatment of Rosacea (NCT03708263)

Eligibility criteria:
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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years

Patient description (medical language): A 41-year-old woman comes to the dermatology clinic complaining of facial redness, especially on her forehead and cheeks. She noticed that the redness gets worse in the summer and after sun exposure. She is otherwise healthy. On physical examination, she has multiple papules and pustules present on her forehead, cheeks, and nose on a background of erythema and telangiectasias. There are no other lesions or nodules. The patient is married and has 2 children who are 5 and 9 years old. She has IUD and doesn't wish to have more kids. She does not smoke or drink alcohol. Her vital signs are normal, and BMI is 21.

Patient description (patient's own words): I'm 41, married with 2 lovely kids who are 5 and 9 years old. I have an IUD and I don't want to have more kids. I don't smoke or drink alcohol. I had to go to the dermatology clinic because I had terrible redness on my face, especially on my forehead and cheeks. It got worse in the summer and after being under the sun. I'm usually healthy. They conducted a physical exam and they found several lesions and pustules on my forehead, cheeks and nose and they also found some signs of erythema and telangiectasia. My vitals were normal, and my BMI is 21.

Does the patient match the trial criteria? Contradiction