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

Not Applicable

Completed

• Conditions: Telangiectasia
• Interventions: Device: pulsed dye laser

• Registration Number: NCT05036200
• Lead Sponsor: University Hospital, Caen

Brief 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).

Detailed 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)

Study Timeline

• Study Start: 2019-08-01
• Primary Completion: 2019-09-01
• Study Completion: 2020-07-01
• Status Verified: 2021-07
• Study First Submitted: 2021-07-19
• Study First Submitted QC: 2021-08-30
• Last Update Submitted: 2021-08-30
• Study First Posted: 2021-09-05
• Last Update Posted: 2021-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
four pulsed dye laser sessions were administered every eight weeks in the 21 patients	pulsed dye laser	-

Primary Outcome Measures

Name	Time	Method
Evaluation of the decrease in the number of telangiectasia	baseline and two months after last intervention

Secondary Outcome Measures

Name	Time	Method
Assessment of quality of life after pulsed dye laser treatment using the SKINDEX questionnaire	baseline and two months after last intervention

Trial Locations

Locations (1)

Chu Caen Normandie; 🇫🇷 Caen, Normandie, France