An interventional study of pulsed dye laser in Telangiectasia, sponsored by University Hospital, Caen. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-02.
Sponsored by University Hospital, Caen · Not applicable, Interventional, and Treatment
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).
Primary Objective:
To evaluate the efficacy of pulsed dye laser treatment on facial and neckline telangiectasias in systemic scleroderma by comparing the mean number of telangiectasias.
Secondary Objectives:
Evaluation of the aesthetic efficacy by the patient, observer and adjudication committee Evaluation of the impact on the quality of life after treatment (skindex) Evaluation of treatment tolerance in terms of pain (VAS) and adverse events (purpura, oozing, hyperpigmentation, hospitalization)
69 studies on the registry are indexed under Telangiectasis; 12 are open to participants now.
This study's enrollment of 21 is below the median of 30 across 59 interventional studies indexed under Telangiectasis.
Browse Telangiectasis studies →University Hospital, Caen is the lead sponsor of 512 studies on the registry; 82 are open to participants now.
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Exclusion Criteria:
Device: pulsed dye laser
four pulsed dye laser sessions were administered every eight weeks in the 21 patients
Evaluation of the decrease in the number of telangiectasia
Time frame: baseline and two months after last intervention
Assessment of quality of life after pulsed dye laser treatment using the SKINDEX questionnaire
Time frame: baseline and two months after last intervention
evaluation of the aesthetic improvement with an improvement score scored using a LIKERT scale from -1 to +2: from -1= worse; 0= unchanged ; +1= improved ; +2= much improved
Time frame: baseline and two months after last intervention
Plan to share: No
Ran from Aug 2019 to primary completion in Sep 2019, 1 month.
Of 14 interventional studies with no phase under Telangiectasis, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 27. This study's 1 month is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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