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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).
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| four pulsed dye laser sessions were administered every eight weeks in the 21 patients | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pulsed dye laser | Device | four pulsed dye laser sessions were administered every eight weeks in the 21 patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the decrease in the number of telangiectasia | baseline and two months after last intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of quality of life after pulsed dye laser treatment using the SKINDEX questionnaire | baseline and two months after last intervention |
| Measure | Description | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Caen Normandie | Caen | Normandy | 14000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23899131 | Background | 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. | |
| 25797836 | Background | 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. |
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| ID | Term |
|---|---|
| D013684 | Telangiectasis |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D054025 | Lasers, Dye |
| ID | Term |
|---|---|
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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| 38373440 | Result | 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. |