Clinical trial NCT04717583: Efficacy of Intense Pulsed Light in the Treatment of Facial Telangiectasia in Systemic Lupus Erythematosus
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Facial Telangiectasia in Patients With Systemic Lupus Erythematosus
Keywords: Systemic lupus erythematosus
Intense pulsed light
Facial telangiectasia
corticosteroids
Lead sponsor: Second Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change of Five-Point Telangiectasia Scale after three times of IPL treatment
timeFrame: 12 weeks
Secondary outcomes:
measure: Change of Five-Point Telangiectasia Scale after 4, 8, and 24 weeks, respectively.
timeFrame: 4, 8, and 24 weeks
measure: Change of Clinician's Erythema Assessment (CEA) scores after a 4-, 8-, 12- and 24-week treatment, respectively.
timeFrame: 4, 8, 12, and 24 weeks
measure: Change of Patient Global Assessment (PGA) after a 4-, 8-, 12- and 24-week treatment, respectively.
timeFrame: 4, 8, 12, and 24 weeks
measure: Change of Dermatology Life Quality Index (DLQI) scores after a 4-, 8-, 12-, and 24-week of treatment, respectively.
timeFrame: 4, 8, 12, and 24 weeks
measure: Change of Skindex-16 scores after a 4-, 8-, 12- and 24-week of treatment, respectively.
timeFrame: 4, 8, 12, and 24 weeks
measure: The safety evaluation about the adverse reactions throughout the entire study process.
timeFrame: 4, 8, 12, 16, and 36 weeks
measure: Change of SLEDAI scores after 12 and 24 weeks, respectively
timeFrame: 12 and 24 weeks
Other outcomes:
Locations:
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Human
Study officials:
References: