Telangiectasia
Conditions
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)
Interventions
DEVICEpulsed dye laser
four pulsed dye laser sessions were administered every eight weeks in the 21 patients
Sponsors
University Hospital, Caen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of the decrease in the number of telangiectasia | baseline and two months after last intervention |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of quality of life after pulsed dye laser treatment using the SKINDEX questionnaire | baseline and two months after last intervention |
Countries
France
Outcome results
None listed