CompletedNot Applicable

Pilot Study to Evaluate the Interest of PDL in the Management of Telangiectasia of the Face and Neckline in Systemic Scleroderma

France21 participantsStarted 2019-08-01

Plain-language summary

This single-center, prospective, open-label, quasi-experimental, intra-individual comparative study will include a consecutive cohort of 21 patients with diffuse or limited, minimally active scleroderma with 3 to 30 years of evolution. Patients will have 4 sessions of pulsed dye laser 595 nm spaced 8 weeks apart. The final quadruple evaluation by several evaluators will be 2 months after the last session, on the following criteria: evolution of the number of telangiectasia; subjective improvement score (LINKERT scale); impact on quality of life (SKINDEX score); visual analog pain scale (VAS); adverse events (AEs), including discontinuation of treatment due to post-session purpura (AT-PPS); patient satisfaction (yes or no).

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * patient followed in dermatology and/or internal medicine at the University Hospital of Caen for systemic scleroderma * patient with telangiectasias related to scleroderma * patient with an aesthetic prejudice Exclusion Criteria: * Patient with previous laser treatment for facial telangiectasias. * Tanned, irritated or traumatized facial skin * Patient not affiliated to the Social Security system * Pregnancy

What they're measuring

Evaluation of the decrease in the number of telangiectasia

Timeframe: baseline and two months after last intervention

Trial details

NCT IDNCT05036200

SponsorUniversity Hospital, Caen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-09-01

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