Clinical trial NCT05036200: Pilot Study to Evaluate the Interest of PDL in the Management of Telangiectasia of the Face and Neckline in Systemic Scleroderma
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Telangiectasia
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2021-09-05
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of the decrease in the number of telangiectasia
timeFrame: baseline and two months after last intervention
Secondary outcomes:
measure: Assessment of quality of life after pulsed dye laser treatment using the SKINDEX questionnaire
timeFrame: baseline and two months after last intervention
Other outcomes:
measure: 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
timeFrame: baseline and two months after last intervention
Locations:
city: Caen
country: France
facility: Chu Caen Normandie
state: Normandie
Study officials:
References:
citation: 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.
citation: 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.