Pilot Study to Evaluate the Interest of PDL in the Management of Telangiectasia of the Face and Neckline in Systemic Scleroderma

Telangiectasia Clinical Trial

— PDL  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05036200
• Other study ID #: 19-065
• Status: Completed
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: July 1, 2020

Study information

• Verified date: July 2021
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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).

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: July 1, 2020
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Scleroderma, Diffuse
• Scleroderma, Systemic
• Telangiectasia
• Telangiectasis

Intervention

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

Locations

Country	Name	City	State
France	Chu Caen Normandie	Caen	Normandie

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Evaluation of the decrease in the number of telangiectasia		baseline and two months after last intervention
Secondary	Assessment of quality of life after pulsed dye laser treatment using the SKINDEX questionnaire		baseline and two months after last intervention