Efficacy of Intense Pulsed Light in the Treatment of Facial Telangiectasia in Systemic Lupus Erythematosus

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Facial Telangiectasia in Patients With Systemic Lupus Erythematosus

Intervention / Treatment
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* Procedure: Intense pulsed light (IPL) treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IPL-treated side<br>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. | Procedure: Intense pulsed light (IPL) treatment<br>* 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.<br>|
| No Intervention: Control side<br>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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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 | 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. | 12 and 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Systemic lupus erythematosus, Intense pulsed light, Facial telangiectasia, corticosteroids