Facial Telangiectasia in Patients With Systemic Lupus ErythematosusNCT04717583
Efficacy of Intense Pulsed Light in the Treatment of Facial Telangiectasia in Systemic Lupus Erythematosus
A study testing Intense pulsed light (IPL) treatment in people with Facial Telangiectasia in Patients With Systemic Lupus Erythematosus, run by Second Xiangya Hospital of Central South University at 1 site in China.
Trial summary
This clinical trial intends to evaluate the efficacy and safety of intense pulsed light (IPL) in the treatment of facial telangiectasia in patients with systemic lupus erythematosus (SLE). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Facial Telangiectasia in Patients With Systemic Lupus Erythematosus
- What is being tested?
- Intense pulsed light (IPL) treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2021to Dec 2022
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Age: between 18 and 65 years; 2. Patients definitedly diagnosed with systemic lupus erythematosus according to "Diagnostic Criteria for systemic lupus erythematosus"; 3. Patients receiving continuous treatment of glucocorticoid in the last 4 weeks.
Who cannot join
- 1. Patients with severe diseases of heart, brain, lungs, liver, kidney, or blood system; 2. Patients with drug abuse, alcohol abuse, or mental disorders that are unable to cooperate or adhere to treatment; 3. Pregnant women, lactating women or women who are ready to conceive within 6 months; 4. Participated in other clinical trials within 3 months before the screening.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Xiangya Hospital of Central South University
Changsha, Human, 410011
Hai Long, MD, PhD, 18229743206, dr.hailong@csu.edu.cn
About this study
Official title: Efficacy of Intense Pulsed Light (IPL) in the Treatment of Facial Telangiectasia in Patients With Systemic Lupus Erythematosus (SLE): a Randomized, Evaluator-blinded, Split-face Comparative Clinical Trial
This clinical trial intends to evaluate the efficacy and safety of intense pulsed light (IPL) in the treatment of facial telangiectasia in patients with systemic lupus erythematosus (SLE).
Read the detailed description
Systemic lupus erythematosus (SLE) is a chronic autoimmune disease that can involve multiple organs and systems. The treatment for SLE mainly depends on long-term use of glucocorticoids. For many patients with SLE, facial telangiectasia is a commonly seen side effect of long-term use of glucocorticoids. Featured by facial erythema with or without flushing or burning sensation, facial telangiectasia seriously affects the quality of life of patients. However, up to now, there has been little attention paid to this condition in SLE patients. There have been a lack of effective treatment options for tackling this problem.
Intense pulsed light (IPL) is a non-laser light source used to treat a variety of vascular and pigmented lesions. Unlike ultraviolet that is harmful to patients with SLE, application of IPL may be a safe and effective treatment for SLE patients with facial telangiectasia. This study intends to evaluate the efficacy and safety of IPL in the treatment of facial telangiectasia for SLE patients that has been treated with long-term corticosteroids.
- Being tested
- Intense pulsed light (IPL) treatment
- Keywords
- Systemic lupus erythematosus, Intense pulsed light, Facial telangiectasia, corticosteroids
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intense pulsed light (IPL) treatmentProcedure or surgery
After randomization, one side of the face will be treated with IPL using the M22™ Universal IPL device, once every 4 weeks for 3 consecutive times.
Starting from Week 12 (the time point of the primary endpoint), the control side of face will also be treated by IPL if the IPL-treated side shows satisfactory improvement of erythema or telangiectasia by IPL treatment. If the patient was unsatisfied with the improvement in the IPL-treated side at Week 12 visit, no IPL treatment will be given to either side of the face any more.
| Study group | Role | What they receive |
|---|---|---|
| IPL-treated side | Experimental | For each participant, the two sides of face will be randomized into an IPL-treated side and a control side. In the first 3 visits, the IPL-treated side of the face will be treated with IPL, once every 4 weeks for 3 consecutive times. Receives: Procedure: Intense pulsed light (IPL) treatment |
| Control side | No intervention | For each participant, the two sides of face will be randomized into an IPL-treated side and a control side. In the first 3 visits (before Week 12), the control side of face will not be treated by IPL. Starting from Week 12 (the time point of the primary endpoint), the control side of face will also be treated by IPL if the IPL-treated side shows satisfactory improvement of erythema or telangiectasia by IPL treatment. If the patient was unsatisfied with the improvement in the IPL-treated side at Week 12 visit, no IPL treatment will be given to either side of the face any more. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Five-Point Telangiectasia Scale after three times of IPL treatment
Five-Point Telangiectasia Scale will be used to assess improvement of telangiectasia and erythema. The range of TGS is 1 to 5, where 1 means less than 5% clearance, 2 means 5-25% clearance, 3 means 25-50% clearance, 4 means 50-75% clearance, and 5 means 75-100% clearance, compared to baseline before IPL treatment.
Measured: 12 weeks
Secondary outcomes (7)
Change of Five-Point Telangiectasia Scale after 4, 8, and 24 weeks, respectively.
Five-Point Telangiectasia Scale will be used to assess improvement of telangiectasia and erythema. The range of TGS is 1 to 5, where 1 means less than 5% clearance, 2 means 5-25% clearance, 3 means 25-50% clearance, 4 means 50-75% clearance, and 5 means 75-100% clearance, compared to baseline before IPL treatment.
Measured: 4, 8, and 24 weeks
Change of Clinician's Erythema Assessment (CEA) scores after a 4-, 8-, 12- and 24-week treatment, respectively.
Clinician's Erythema Assessment (CEA) scores describe the severity of facial erythema, ranging from 0-4. In CEA scoring system, 0=clear, and 4=severe.
Measured: 4, 8, 12, and 24 weeks
Change of Patient Global Assessment (PGA) after a 4-, 8-, 12- and 24-week treatment, respectively.
PGA refers to the subject's global assessment of the facial telangiectasia condition. Change of PGA from baseline to post-treatment will be determined.
Measured: 4, 8, 12, and 24 weeks
Change of Dermatology Life Quality Index (DLQI) scores after a 4-, 8-, 12-, and 24-week of treatment, respectively.
Change of DLQI from baseline to post-treatment will be determined.
Measured: 4, 8, 12, and 24 weeks
Change of Skindex-16 scores after a 4-, 8-, 12- and 24-week of treatment, respectively.
Change of Skindex-16 from baseline to post-treatment will be determined.
Measured: 4, 8, 12, and 24 weeks
The safety evaluation about the adverse reactions throughout the entire study process.
The possible adverse reactions of IPL include rash, pain, short-term pigmentation, recurrence of telangitic erythema, recurrence or aggravation of SLE
Measured: 4, 8, 12, 16, and 36 weeks
Change of SLEDAI scores after 12 and 24 weeks, respectively
SLEDAI reflects the disease activity of SLE. A dramatic increase of SLEDAI during the IPL treatment or immediately after IPL treatment will be considered as an adverse event.
Measured: 12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start1 Feb 2021
- Primary completionJul 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial Telangiectasia in Patients With Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Second Xiangya Hospital of Central South UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qianjin Lu, MD, PhD, Second Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04717583
- Sponsor's protocol ID
- SecondXHCSU-PFK2020SLE01
- Status last verified
- May 2021
- First submitted
- 17 Jan 2021
- Last updated
- 18 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Intense Pulsed Light (IPL) in the Treatment of Facial Telangiectasia in Patients With Systemic Lupus Erythematosus (SLE): a Randomized, Evaluator-blinded, Split-face Comparative Clinical Trial
- ClinicalTrials.gov ID
- NCT04717583
- Acronym / sponsor ID
- SecondXHCSU-PFK2020SLE01
- Keywords
- Systemic lupus erythematosus, Intense pulsed light, Facial telangiectasia, corticosteroids
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Second Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 22 Jan 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 clinical trial intends to evaluate the efficacy and safety of intense pulsed light (IPL) in the treatment of facial telangiectasia in patients with systemic lupus erythematosus (SLE).
Detailed description
Systemic lupus erythematosus (SLE) is a chronic autoimmune disease that can involve multiple organs and systems. The treatment for SLE mainly depends on long-term use of glucocorticoids. For many patients with SLE, facial telangiectasia is a commonly seen side effect of long-term use of glucocorticoids. Featured by facial erythema with or without flushing or burning sensation, facial telangiectasia seriously affects the quality of life of patients. However, up to now, there has been little attention paid to this condition in SLE patients. There have been a lack of effective treatment options for tackling this problem.
Intense pulsed light (IPL) is a non-laser light source used to treat a variety of vascular and pigmented lesions. Unlike ultraviolet that is harmful to patients with SLE, application of IPL may be a safe and effective treatment for SLE patients with facial telangiectasia. This study intends to evaluate the efficacy and safety of IPL in the treatment of facial telangiectasia for SLE patients that has been treated with long-term corticosteroids.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IPL-treated side | Experimental | Procedure: Intense pulsed light (IPL) treatmentFor each participant, the two sides of face will be randomized into an IPL-treated side and a control side. In the first 3 visits, the IPL-treated side of the face will be treated with IPL, once every 4 weeks for 3 consecutive times. |
| Control side | No intervention | –For each participant, the two sides of face will be randomized into an IPL-treated side and a control side. In the first 3 visits (before Week 12), the control side of face will not be treated by IPL. Starting from Week 12 (the time point of the primary endpoint), the control side of face will also be treated by IPL if the IPL-treated side shows satisfactory improvement of erythema or telangiectasia by IPL treatment. If the patient was unsatisfied with the improvement in the IPL-treated side at Week 12 visit, no IPL treatment will be given to either side of the face any more. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Age: between 18 and 65 years; 2. Patients definitedly diagnosed with systemic lupus erythematosus according to "Diagnostic Criteria for systemic lupus erythematosus"; 3. Patients receiving continuous treatment of glucocorticoid in the last 4 weeks.
Key exclusion criteria (1 listed)
- 1. Patients with severe diseases of heart, brain, lungs, liver, kidney, or blood system; 2. Patients with drug abuse, alcohol abuse, or mental disorders that are unable to cooperate or adhere to treatment; 3. Pregnant women, lactating women or women who are ready to conceive within 6 months; 4. Participated in other clinical trials within 3 months before the screening.
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 |
|---|---|---|
| Intense pulsed light (IPL) treatmentAfter randomization, one side of the face will be treated with IPL using the M22™ Universal IPL device, once every 4 weeks for 3 consecutive times. Starting from Week 12 (the time point of the primary endpoint), the control side of face will also be treated by IPL if the IPL-treated side shows satisfactory improvement of erythema or telangiectasia by IPL treatment. If the patient was unsatisfied with the improvement in the IPL-treated side at Week 12 visit, no IPL treatment will be given to either side of the face any more. | Procedure or surgery | IPL-treated side |
Primary outcome
Change of Five-Point Telangiectasia Scale after three times of IPL treatment
Time frame: 12 weeks
Five-Point Telangiectasia Scale will be used to assess improvement of telangiectasia and erythema. The range of TGS is 1 to 5, where 1 means less than 5% clearance, 2 means 5-25% clearance, 3 means 25-50% clearance, 4 means 50-75% clearance, and 5 means 75-100% clearance, compared to baseline before IPL treatment.
7 secondary outcomes
Change of Five-Point Telangiectasia Scale after 4, 8, and 24 weeks, respectively.
Time frame: 4, 8, and 24 weeks
Change of Clinician's Erythema Assessment (CEA) scores after a 4-, 8-, 12- and 24-week treatment, respectively.
Time frame: 4, 8, 12, and 24 weeks
Change of Patient Global Assessment (PGA) after a 4-, 8-, 12- and 24-week treatment, respectively.
Time frame: 4, 8, 12, and 24 weeks
Change of Dermatology Life Quality Index (DLQI) scores after a 4-, 8-, 12-, and 24-week of treatment, respectively.
Time frame: 4, 8, 12, and 24 weeks
Change of Skindex-16 scores after a 4-, 8-, 12- and 24-week of treatment, respectively.
Time frame: 4, 8, 12, and 24 weeks
The safety evaluation about the adverse reactions throughout the entire study process.
Time frame: 4, 8, 12, 16, and 36 weeks
Change of SLEDAI scores after 12 and 24 weeks, respectively
Time frame: 12 and 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intense pulsed light (IPL) treatment in people with Facial Telangiectasia in Patients With Systemic Lupus Erythematosus, run by Second Xiangya Hospital of Central South University 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 18 May 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qianjin Lu (13787097676, qianlu5860@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Five-Point Telangiectasia Scale after three times of IPL treatment (time frame: 12 weeks). 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 18 May 2021.