Telangiectasia Clinical Trial
— PDLOfficial 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
NCT number | NCT05036200 |
Other study ID # | 19-065 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 1, 2019 |
Est. completion date | July 1, 2020 |
Verified date | July 2021 |
Source | University Hospital, Caen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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 |
Country | Name | City | State |
---|---|---|---|
France | Chu Caen Normandie | Caen | Normandie |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Caen |
France,
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
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 |
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