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

Study Overview
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Brief Summary
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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).

Detailed Description
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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)

Official Title
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Efficacy, Tolerance and Acceptability of Pulsed Dye Laser on Telangiectasias of the Face and Neckline in Systemic Scleroderma: a Prospective Single-center Open-label Study of 21 Patients

Conditions
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Telangiectasia

Intervention / Treatment
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* Device: pulsed dye laser


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: four pulsed dye laser sessions were administered every eight weeks in the 21 patients<br> | Device: pulsed dye laser<br>* four pulsed dye laser sessions were administered every eight weeks in the 21 patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the decrease in the number of telangiectasia |  | baseline and two months after last intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of quality of life after pulsed dye laser treatment using the SKINDEX questionnaire |  | baseline and two months after last intervention |