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

Ongoing / closed: Ongoing

Research type (rétro/prospective): Prospective, single blinded pilot study, monocentric & randomized.

Synopsis: Erythemato-telangiectatic rosacea is a frequent dermatological condition, with a chronic and disturbing evolution that is characterized by redness, permanent erythema associated with telangiectasia or rosacea (visible and permanent dilatation of the small vessels). Rosacea is associated or not with flushing and there is always facial hypersensitivity, with sensations of burning and skin discomfort.

To counteract the unaesthetic appearance of redness and eliminate telangiectasia, the use of laser can be proposed to the patient.

Two types of devices are generally used, with some efficiency and no particular problem. These lasers each emit a different wavelength: the green KTP (Potassium Titanyl Phosphate) laser at 532 nm and the pulsed dye yellow laser with a wavelength of 585 or 590 nm but which is however quite expensive.
New lasers, also emitting in yellow, are recently appeared with a solid laser technology so less expensive, very compact and technically very reliable. This is the case of the Laser Photolase PLV-585nm which emits yellow light at a wavelength of 585 nm. The advantage of emitting yellow light is that its wavelength makes it possible to increase the depth of penetration and thus a better destruction of the vessels.

So, this new yellow laser PHOTOLASE PLV-585nm could be a new treatment option for telangiectasia.

Principal Investigator: Dr Céline DERMAUX LAVOGIEZ (Dermatology Dpt - University Hospital of Lille - France)

Scientific coordinators: Pr. Serge Mordon (INSERM - France)

Study Sponsor: University Hospital of Lille - France

Primary endpoint: Comparison of the action of the PHOTOLASE PLV-585nm laser and the KTP Excel V 532 nm laser for improving the symptoms of rosacea in terms of reduction of telangiectasia score (TGS) at 2 months

Secondary endpoints:

• Comparison of the safety of use of lasers,
• Evolution of the colour of telangiectasia between each visit
• Improved clinical signs of rosacea at 4, 6 and 12 months after the first laser treatment session
• Patient's satisfaction with the evolution of the symptoms and Practitioner’s satisfaction regarding the use of both devices

Evaluation criteria of the primary endpoint: Comparison of a 7-points scale (Telangiectasia Grading Score TGS) for both treatments measured at visit 3 (2 months)

Evaluation criteria of the secondary endpoints:

• Number and type of side effects
• Assessment of pain by the patient using a visual analogical scale graduated from 1 to 10
• CR400 chromameter measurement of skin color / intensity of telangiectasia on affected areas on each side of the face
• Comparison of TGS scores for both visits 4, 5 and 6
• Comparison of Dermatology Life Quality Index (DLQI) scores at visits 3,4,5 and 6

Estimated enrollment: 20 patients

Clinicaltrials.gov identifier: NCT03708263

Contact and location: Fabienne Lecomte, Inserm, France