Erythematotelangiectatic Rosacea Clinical Trial
— ROSAPHOTOLASEOfficial title:
A Single-blinded, Monocentric, Randomized Pilot Study, to Evaluate the Yellow Laser PHOTOLASE PLV-585nm Versus the Reference Green Laser (KTP Excel V 532 nm) in the Treatment of Erythematotelangiectatic Rosacea
Verified date | February 2022 |
Source | University Hospital, Lille |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 1 |
Est. completion date | September 14, 2021 |
Est. primary completion date | September 14, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Hop Claude Huriez Chu Lille | Lille |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Lille | Institut National de la Santé Et de la Recherche Médicale, France, Medical Research Fund of the Tampere University Hospital, Finland |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Degree of improvement in Erythematotelangiectatic Rosacea | Measured, for each treatment arm, based on blinded physician assessment of subject photographs using the 7 points Telangiectasia Grading Score.
(-1 = Aggravation of telangiectasia, 0 = no change, 1 = poor improvement (<25% decrease), 2 = intermediate improvement (25-50% decrease), 3 significant improvement (50-75% decrease), 4 = very significant improvement (75-99% decrease), 5 = complete improvement (100% decrease) |
at Month 2 | |
Secondary | Degree of improvement in Erythematotelangiectatic Rosacea evaluated by a blinded physician. | Measured, for each treatment arm, based on subject photographs using the 7 points Telangiectasia Grading Score | at Month 4, 6,12 | |
Secondary | Measures of skin reaction for each treatment arm | Measured with a 4 points scale : no reaction, low, moderate and severe reaction | At baseline, At Month 2, At Month 4 (if realized) | |
Secondary | Pain evaluation during each treatment | Mosby Pain Rating Scale for each treatment arm | At baseline, At Month 2, At Month 4 (if realized) | |
Secondary | Change in lesion skin color in each treatment arm | Measured with Chroma-Meter CR400 (Konica Minolta), Mean a* value | At Baseline, at Month 2, 4, 6,12 | |
Secondary | Subject satisfaction level | Comparison of each treatment arm using Subject Overall Evolution Scale | At Month 6,12 | |
Secondary | Change in Life Quality | Comparison of Dermatology Life Quality Index | At Selection, at Baseline, at Month 2, 4 (if realized), 6,12 | |
Secondary | Practitioner's opinion | Comparison, for each treatment arm, of comfort of use, practicality, duration of treatment | At baseline, At Month 2, At Month 4 (if realized) | |
Secondary | Adverse Events | Incidence and severity of adverse effects, for each treatment arm, during the study period | At Baseline, At Month 2, 4, 6,12 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02268474 -
Excel V 532 nm KTP Laser for Treatment of Erythematotelangiectatic Rosacea & Papulopustular Rosacea
|
N/A | |
Completed |
NCT00989014 -
Dose-Finding Study of CD07805/47 Topical Gel in Subjects With Erythematotelangiectatic Rosacea
|
Phase 2 | |
Completed |
NCT01756027 -
Feasibility Study: Ulthera System for the Treatment of Rosacea
|
N/A | |
Completed |
NCT06331533 -
Intradermal BoNT-A Treatment in Erythematotelangiectatic Rosacea
|
Phase 4 | |
Completed |
NCT02144181 -
Ultherapy® for the Treatment of Erythematotelangiectatic Rosacea
|
N/A | |
Recruiting |
NCT05360251 -
Pulsed Dye Laser and Intense Pulsed Light Configured With Different Wavelength Bands in Improving Erythematotelangiectatic Rosacea
|
N/A | |
Completed |
NCT01045551 -
Open Label Pilot Study of Apremilast in Treatment of Rosacea
|
Phase 2 | |
Completed |
NCT00945373 -
Combination Therapy for the Treatment of Rosacea
|
Phase 1 | |
Completed |
NCT04153188 -
Pulsed Dye Laser Treatment and Oxymetazoline Hydrochloride (HCL) 1% Cream for Erythematotelangiectatic Rosacea
|
Phase 4 | |
Completed |
NCT02393937 -
A Therapeutic Equivalence Study of Two Metronidazole Gel 1% Topical Treatments of Rosacea
|
Phase 3 | |
Completed |
NCT02052999 -
Study to Evaluate the Efficacy and Safety of PAC-14028 Cream in Rosacea Patients
|
Phase 2 |