NCT05036200

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 19, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 5, 2021

Completed
Last Updated

April 2, 2026

Status Verified

July 1, 2021

Enrollment Period

1 month

First QC Date

July 19, 2021

Last Update Submit

March 30, 2026

Conditions

Telangiectasia

Outcome Measures

Primary Outcomes (1)

  • Evaluation of the decrease in the number of telangiectasia

    baseline and two months after last intervention

Secondary Outcomes (1)

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

    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

    baseline and two months after last intervention

Study Arms (1)

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

EXPERIMENTAL
Device: pulsed dye laser

Interventions

pulsed dye laserDEVICE

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

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patient with previous laser treatment for facial telangiectasias.
  • Tanned, irritated or traumatized facial skin
  • Patient not affiliated to the Social Security system
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Caen Normandie

Caen, Normandy, 14000, France

Location

Related Publications (3)

  • 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.

    PMID: 23899131BACKGROUND

  • 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.

    PMID: 25797836BACKGROUND

  • Kottler D, Dupechez L, Martin Silva N, Boutemy J, Dumont A, Maigne G, Aouba A, Dompmartin A. Efficacy, tolerance and acceptability of pulsed dye laser on facial and neckline telangiectasias in systemic scleroderma: a prospective open-label monocentric study in 21 patients. J Cosmet Laser Ther. 2023 Nov 17;25(5-8):77-85. doi: 10.1080/14764172.2024.2313472. Epub 2024 Feb 19.

    PMID: 38373440RESULT

MeSH Terms

Conditions

Telangiectasis

Interventions

Lasers, Dye

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

LasersOptical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2021

First Posted

September 5, 2021

Study Start

August 1, 2019

Primary Completion

September 1, 2019

Study Completion

July 1, 2020

Last Updated

April 2, 2026

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)