TelangiectasiaNCT04795310
Clinical Observation of Pulsed Dye Laser and Intense Pulsed Light in Treating Facial Telangiectasia
A study testing Pulsed dye laser in people with Telangiectasia, run by Xijing Hospital at 1 site in China.
Trial summary
1. Facial telangiectasia is one of the common skin vascular lesions characterized by dilated cutaneous vasculatures in the skin surface or mucous membranes. Lesions are generally sensitive to exposure of cold, heat and sun. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- 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
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 1 Jan 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects must be clinically diagnosed with facial telangiectasia
- No other external treatment was performed before the injury was treated
Who cannot join
- subjects with a recent history of exposure to sunlight
- subjects allergic to topical anesthesia
- subjects with scar constitution
- subjects with skin malignant tumors or precancerous lesions
- subjects with diabetes, heart disease, epilepsy, connective tissue disease, etc
- subjects who Pregnant or breast feeding
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- subjects with recent skin infections (such as viruses, bacteria, etc.)
- other methods are being used to treat subjects with similar diseases
- subject who have taken isotretinoin A in the past year
- subject with facial dermatitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Observation on the Efficacy and Safety of Pulsed Dye Laser and Intense Pulsed Light With Different Wavelength Bands in the Treatment of Facial Telangiectasia: a Retrospective, Self-controlled Trial
- Facial telangiectasia is one of the common skin vascular lesions characterized by dilated cutaneous vasculatures in the skin surface or mucous membranes. Lesions are generally sensitive to exposure of cold, heat and sun. Those distinct small dilated blood vessels are cosmetically disfiguring for patients which require an effective solution. The traditional management options for facial telangiectasia include cryotherapy, CO2 laser, topical agent, oral estrogens, electrosurgery, and radioactive treatment. However, inadequate outcomes and severe adversaries are the major concerns to patients and physicians.
- Pulsed dye laser (PDL) is effective for vasodilatory diseases, especially for the superficial to middle layers of the dermis. The intense pulsed light source is an alternative or supplement to the already existing laser devices that are part of the laser surgeon's repertoire. The broad wavelength spectrum and variable pulse duration allow greater penetration depths to be reached without damaging surrounding tissue and thus enhance the versatility of this system.
- This study aims to compare the clearance efficacy of facial telangiectasia using PDL (595nm) with IPL configured by various wavelength bands, including M22 vascular filter (530-650nm and 900-1200nm), M22 560 (560-1200nm), M22 590 (590-1200nm) .
Read the detailed description
Detailed Description has not been entered.
- Conditions
- Telangiectasia
- Being tested
- Pulsed dye laser
- Keywords
- Facial Telangiectasia, Pulsed dye laser (PDL), Intense Pulsed Light
- 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
Also called Intense pulsed light
PDL (Vbeam perfecta, 595 nm, Candela Corporation, Wayland, MA) was used with energy dosages of 9-11J/cm2, pulse durations of 10ms/20ms, and 7 or 10 mm handpieces with dynamic cooling device (DCD).
IPL device (M22, Lumenis Limited, Yokneam, Israel) with integration of sapphire ChillTip system for epidermal cooling were used in the study. Three wavelength bands were configured: 560-1200 nm, 590-1200 nm, and vascular wavelength bands of 530-650nm and 900-1200nm. All the treatment handpieces had a spot size of 15mm×35mm, fluence of 9-17J/cm², pulse duration of 4.0-6.0ms and pulse delay of 20-40ms, underwent the M22 advanced optimal pulse technology (AOPT) treatment.
| Study group | Role | What they receive |
|---|---|---|
| Pulsed Dye Laser | Experimental | PDL (Vbeam perfecta, 595 nm, Candela Corporation, Wayland, MA) was used with energy dosages of 9-11J/cm2, pulse durations of 10ms/20ms, and 7 or 10 mm handpieces with dynamic cooling device (DCD) Receives: Device: Pulsed dye laser |
| Intense Pulsed Light | Active comparator | Vascular wavelength bands of 530-650nm and 900-1200nm Receives: Device: Pulsed dye laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity index of facial telangiectasia
- minimal, focal visible telangiectasia in 5-10% of anatomic area
- focal visible telangiectasia in11-20% of an anatomic area
- focal visible telangiectasia in 21-30% of anatomic area
- visible telangiectasia in 31-40% of anatomic area
- visible telangiectasia in 41-50% of anatomic area
- moderately severe telangiectasia in 51-60% of anatomic area
- moderately severe telangiectasia in 61-70% of anatomic area
- severe telangiectasia in 71-80% of anatomic area
- severe telangiectasia in 81-90% of anatomic area
- severe and diffuse facial telangiectasia in entire anatomic area for facial telangiectasia
Measured: 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start1 Jan 2019
- Primary completion31 Dec 2019
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TelangiectasiaStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gang Wang, Xijing Hospital
- Investigators
- Gang Wang, Prof, Principal investigator, Dermatology Derpartment of Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04795310
- Sponsor's protocol ID
- XijingH-PF-20192074-C-1
- Status last verified
- Mar 2021
- First submitted
- 2 Jul 2019
- Last updated
- 12 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Observation on the Efficacy and Safety of Pulsed Dye Laser and Intense Pulsed Light With Different Wavelength Bands in the Treatment of Facial Telangiectasia: a Retrospective, Self-controlled Trial
- ClinicalTrials.gov ID
- NCT04795310
- Acronym / sponsor ID
- XijingH-PF-20192074-C-1
- Conditions
- Telangiectasia
- Keywords
- Facial Telangiectasia, Pulsed dye laser (PDL), Intense Pulsed Light
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 12 Mar 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.
- Facial telangiectasia is one of the common skin vascular lesions characterized by dilated cutaneous vasculatures in the skin surface or mucous membranes. Lesions are generally sensitive to exposure of cold, heat and sun. Those distinct small dilated blood vessels are cosmetically disfiguring for patients which require an effective solution. The traditional management options for facial telangiectasia include cryotherapy, CO2 laser, topical agent, oral estrogens, electrosurgery, and radioactive treatment. However, inadequate outcomes and severe adversaries are the major concerns to patients and physicians.
- Pulsed dye laser (PDL) is effective for vasodilatory diseases, especially for the superficial to middle layers of the dermis. The intense pulsed light source is an alternative or supplement to the already existing laser devices that are part of the laser surgeon's repertoire. The broad wavelength spectrum and variable pulse duration allow greater penetration depths to be reached without damaging surrounding tissue and thus enhance the versatility of this system.
- This study aims to compare the clearance efficacy of facial telangiectasia using PDL (595nm) with IPL configured by various wavelength bands, including M22 vascular filter (530-650nm and 900-1200nm), M22 560 (560-1200nm), M22 590 (590-1200nm) .
Detailed description
Detailed Description has not been entered.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulsed Dye Laser | Experimental | Device: Pulsed dye laserPDL (Vbeam perfecta, 595 nm, Candela Corporation, Wayland, MA) was used with energy dosages of 9-11J/cm2, pulse durations of 10ms/20ms, and 7 or 10 mm handpieces with dynamic cooling device (DCD) |
| Intense Pulsed Light | Active comparator | Device: Pulsed dye laserVascular wavelength bands of 530-650nm and 900-1200nm |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Subjects must be clinically diagnosed with facial telangiectasia
- No other external treatment was performed before the injury was treated
Key exclusion criteria (10 listed)
- subjects with a recent history of exposure to sunlight
- subjects allergic to topical anesthesia
- subjects with scar constitution
- subjects with skin malignant tumors or precancerous lesions
- subjects with diabetes, heart disease, epilepsy, connective tissue disease, etc
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 laserAlso: Intense pulsed lightPDL (Vbeam perfecta, 595 nm, Candela Corporation, Wayland, MA) was used with energy dosages of 9-11J/cm2, pulse durations of 10ms/20ms, and 7 or 10 mm handpieces with dynamic cooling device (DCD). IPL device (M22, Lumenis Limited, Yokneam, Israel) with integration of sapphire ChillTip system for epidermal cooling were used in the study. Three wavelength bands were configured: 560-1200 nm, 590-1200 nm, and vascular wavelength bands of 530-650nm and 900-1200nm. All the treatment handpieces had a spot size of 15mm×35mm, fluence of 9-17J/cm², pulse duration of 4.0-6.0ms and pulse delay of 20-40ms, underwent the M22 advanced optimal pulse technology (AOPT) treatment. | Device | Intense Pulsed Light, Pulsed Dye Laser |
Primary outcome
Severity index of facial telangiectasia
Time frame: 6months
1. minimal, focal visible telangiectasia in 5-10% of anatomic area 2. focal visible telangiectasia in11-20% of an anatomic area 3. focal visible telangiectasia in 21-30% of anatomic area 4. visible telangiectasia in 31-40% of anatomic area 5. visible telangiectasia in 41-50% of anatomic area 6. moderately severe telangiectasia in 51-60% of anatomic area 7. moderately severe telangiectasia in 61-70% of anatomic area 8. severe telangiectasia in 71-80% of anatomic area 9. severe telangiectasia in 81-90% of anatomic area 10. severe and diffuse facial telangiectasia in entire anatomic area for facial telangiectasia
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 12 Mar 2021.
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Harmony-HHT: ATV-1601 in Participants With Hereditary Hemorrhagic Telangiectasia (HHT)
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A Pivotal Study of N-Acetyl-L-Leucine on Ataxia-Telangiectasia (A-T)
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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.
Gang Wang, Prof principal investigator
Dermatology Derpartment of Xijing Hospital
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 Xijing Hospital at 1 site in China.
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 2 inclusion and 10 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 12 Mar 2021. 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 China. 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?
Severity index of facial telangiectasia (time frame: 6months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2021.