Facial Telangiectasia in Patients With Systemic Lupus Erythematosus
Conditions
Keywords
Systemic lupus erythematosus, Intense pulsed light, Facial telangiectasia, corticosteroids
Brief 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).
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.
Interventions
PROCEDUREIntense pulsed light (IPL) treatment
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.
Sponsors
Second Xiangya Hospital of Central South University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Five-Point Telangiectasia Scale after three times of IPL treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of Clinician's Erythema Assessment (CEA) scores after a 4-, 8-, 12- and 24-week treatment, respectively. | 4, 8, 12, and 24 weeks | 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. |
| Change of Patient Global Assessment (PGA) after a 4-, 8-, 12- and 24-week treatment, respectively. | 4, 8, 12, and 24 weeks | PGA refers to the subject's global assessment of the facial telangiectasia condition. Change of PGA from baseline to post-treatment will be determined. |
| Change of Dermatology Life Quality Index (DLQI) scores after a 4-, 8-, 12-, and 24-week of treatment, respectively. | 4, 8, 12, and 24 weeks | Change of DLQI from baseline to post-treatment will be determined. |
| Change of Five-Point Telangiectasia Scale after 4, 8, and 24 weeks, respectively. | 4, 8, and 24 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. |
| The safety evaluation about the adverse reactions throughout the entire study process. | 4, 8, 12, 16, and 36 weeks | The possible adverse reactions of IPL include rash, pain, short-term pigmentation, recurrence of telangitic erythema, recurrence or aggravation of SLE |
| Change of SLEDAI scores after 12 and 24 weeks, respectively | 12 and 24 weeks | 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. |
| Change of Skindex-16 scores after a 4-, 8-, 12- and 24-week of treatment, respectively. | 4, 8, 12, and 24 weeks | Change of Skindex-16 from baseline to post-treatment will be determined. |
Countries
China
Contacts
Primary ContactQianjin Lu
Backup ContactHai Long
Outcome results
None listed