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Completed

NCT Number: NCT05036200

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

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).

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Key information

Conditions

Telangiectasia Cardiovascular Diseases Telangiectasis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Caen Normandie

Caen, Normandy, 14000, France

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pulsed dye laser

Device

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

Primary outcomes

  1. Evaluation of the decrease in the number of telangiectasia

    Time frame: baseline and two months after last intervention

Secondary outcomes

  1. Assessment of quality of life after pulsed dye laser treatment using the SKINDEX questionnaire

    Time frame: baseline and two months after last intervention

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Official study title

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

Acronym: PDL

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Sep 5, 2021
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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