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

Caen University Hospital

Status: Completed

Conditions: Telangiectasia

Treatments: Device: pulsed dye laser

Study type: Interventional

Funder types: Other

Identifiers

NCT05036200

19-065

Details and patient eligibility

About

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).

Full description

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)

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

four pulsed dye laser sessions were administered every eight weeks in the 21 patients

Experimental group

Treatment:

Device: pulsed dye laser