TelangiectasiaPDLNCT05036200
Pilot Study to Evaluate the Interest of PDL in the Management of Telangiectasia of the Face and Neckline in Systemic Scleroderma
A study testing pulsed dye laser in people with Telangiectasia, run by University Hospital, Caen at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Telangiectasia
- What is being tested?
- pulsed dye laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2019to 1 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patient with previous laser treatment for facial telangiectasias.
- Tanned, irritated or traumatized facial skin
- Patient not affiliated to the Social Security system
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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)
- Conditions
- Telangiectasia
- Being tested
- pulsed dye laser
- Medical subject headings
- Telangiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulsed dye laserDevice
four pulsed dye laser sessions were administered every eight weeks in the 21 patients
| Study group | Role | What they receive |
|---|---|---|
| four pulsed dye laser sessions were administered every eight weeks in the 21 patients | Experimental | Not described Receives: Device: pulsed dye laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the decrease in the number of telangiectasia
Measured: baseline and two months after last intervention
Secondary outcomes (1)
Assessment of quality of life after pulsed dye laser treatment using the SKINDEX questionnaire
Measured: baseline and two months after last intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start1 Aug 2019
- Primary completion1 Sep 2019
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for TelangiectasiaStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05036200
- Sponsor's protocol ID
- 19-065
- Acronym
- PDL
- Status last verified
- Jul 2021
- First submitted
- 19 Jul 2021
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23899131Yalcinkaya 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.
PubMed 25797836Kottler D, Dupechez L, Martin Silva N, Boutemy J, Dumont A, Maigne G, Aouba A, Dompmartin A. Efficacy, tolerance and acceptability of pulsed dye laser on facial and neckline telangiectasias in systemic scleroderma: a prospective open-label monocentric study in 21 patients. J Cosmet Laser Ther. 2023 Nov 17;25(5-8):77-85. doi: 10.1080/14764172.2024.2313472. Epub 2024 Feb 19.
PubMed 38373440
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05036200
- Acronym / sponsor ID
- PDL / 19-065
- Conditions
- Telangiectasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 5 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| four pulsed dye laser sessions were administered every eight weeks in the 21 patients | Experimental | Device: pulsed dye laser |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Patient with previous laser treatment for facial telangiectasias.
- Tanned, irritated or traumatized facial skin
- Patient not affiliated to the Social Security system
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pulsed dye laserfour pulsed dye laser sessions were administered every eight weeks in the 21 patients | Device | four pulsed dye laser sessions were administered every eight weeks in the 21 patients |
Primary outcome
Evaluation of the decrease in the number of telangiectasia
Time frame: baseline and two months after last intervention
1 secondary outcome
Assessment of quality of life after pulsed dye laser treatment using the SKINDEX questionnaire
Time frame: baseline and two months after last intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Background: PubMed 23899131Mayo 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.
- Background: PubMed 25797836Yalcinkaya 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.
- Results publication: PubMed 38373440Kottler D, Dupechez L, Martin Silva N, Boutemy J, Dumont A, Maigne G, Aouba A, Dompmartin A. Efficacy, tolerance and acceptability of pulsed dye laser on facial and neckline telangiectasias in systemic scleroderma: a prospective open-label monocentric study in 21 patients. J Cosmet Laser Ther. 2023 Nov 17;25(5-8):77-85. doi: 10.1080/14764172.2024.2313472. Epub 2024 Feb 19.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pulsed dye laser in people with Telangiectasia, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the decrease in the number of telangiectasia (time frame: baseline and two months after last intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05036200, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.