Clinical Trials Logo

Clinical Trial 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).

Clinical Trial 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 Design

Related Conditions & MeSH terms

NCT number NCT05036200
Study type Interventional
Source University Hospital, Caen
Status Completed
Phase N/A
Start date August 1, 2019
Completion date July 1, 2020

See also
  Status Clinical Trial Phase
Recruiting NCT03646955 - Partial Breast Versus no Irradiation for Women With Early Breast Cancer N/A
Completed NCT00378196 - Ranibizumab in Idiopathic Parafoveal Telangiectasia (RIPT) Trial Phase 1
Recruiting NCT04336163 - Skin Imaging to Inform Laser Treatments N/A
Completed NCT02286804 - Ultherapy for the Treatment of Spider Veins on the Legs N/A
Completed NCT03472859 - Treatment of Dilated Blood Vessels on the Cheeks With a New Yellow Laser and a Traditional Green Laser N/A
Completed NCT01491620 - Study of the 532 nm KTP Laser for the Treatment of Poikiloderma of Civatte N/A
Completed NCT04148950 - Effects of Kinesio Taping Method on Functional Capacity and Quality of Life in Patients With Chronic Venous Disease N/A
Completed NCT00457067 - Injected Ranibizumab to Treat Macular Telangiectasia With New Blood Vessel Formation Phase 1
Completed NCT00457145 - Injected Ranibizumab to Treat Macular Telangiectasia Without New Blood Vessel Formation Phase 1
Completed NCT04795310 - Clinical Observation of Pulsed Dye Laser and Intense Pulsed Light in Treating Facial Telangiectasia N/A
Completed NCT04274842 - D-OCT of Facial Telangiectasia Treated With IPL N/A