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

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

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).

Study Overview

• Status: Completed
• Conditions: Telangiectasia
• Intervention / Treatment: Device: pulsed dye laser

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 Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Normandie
    • Caen, Normandie, France, 14000
      • CHU Caen Normandie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: four pulsed dye laser sessions were administered every eight weeks in the 21 patients	Device: pulsed dye laser; four pulsed dye laser sessions were administered every eight weeks in the 21 patients

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Time Frame
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	baseline and two months after last intervention

Collaborators and Investigators

• Sponsor: University Hospital, Caen

Publications and helpful links

General Publications

• Mayo TT, Khan F, Hunt C, Fleming K, Markus R. Comparative study on bruise reduction treatments after bruise induction using the pulsed dye laser. Dermatol Surg. 2013 Oct;39(10):1459-64. doi: 10.1111/dsu.12293. Epub 2013 Jul 30.
• Yalcinkaya Y, Pehlivan O, Omma A, Alpay N, Erer B, Kamali S, Ocal L, Inanc M. The relationship between nailfold capillaroscopic assessment and telangiectasia score with severity of peripheral vascular involvement in systemic sclerosis. Clin Exp Rheumatol. 2015 Jul-Aug;33(4 Suppl 91):S92-7. Epub 2015 Mar 23.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2019
• Primary Completion (ACTUAL): September 1, 2019
• Study Completion (ACTUAL): July 1, 2020

Study Registration Dates

• First Submitted: July 19, 2021
• First Submitted That Met QC Criteria: August 30, 2021
• First Posted (ACTUAL): September 5, 2021

Study Record Updates

• Last Update Posted (ACTUAL): September 5, 2021
• Last Update Submitted That Met QC Criteria: August 30, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Connective Tissue Diseases; Scleroderma, Systemic; Scleroderma, Diffuse; Telangiectasis
• Other Study ID Numbers: 19-065

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No