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

NCT ID: NCT04717583

Last Updated: 2021-05-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2022-12-31

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.

Conditions

Facial Telangiectasia in Patients With Systemic Lupus Erythematosus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

IPL-treated side

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.

Group Type: EXPERIMENTAL

Intense pulsed light (IPL) treatment

Intervention Type: PROCEDURE

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.

Control side

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Intense 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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Xiangya Hospital of Central South University

OTHER

Sponsor Role: lead

Responsible Party

Qianjin Lu, MD, PhD

Professor and Director, Institute of Dermatology, The Second Xiangya Hospital of Central South University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Second Xiangya Hospital of Central South University

Changsha, Human, China

Site Status: RECRUITING

Countries

China

Central Contacts

Qianjin Lu

Role: CONTACT

qianlu5860@gmail.com

13787097676

Hai Long

Role: CONTACT

dr.hailong@csu.edu.cn

18229743206

Facility Contacts

Hai Long, MD, PhD

Role: primary

dr.hailong@csu.edu.cn

18229743206

Other Identifiers

SecondXHCSU-PFK2020SLE01

Identifier Type: -

Identifier Source: org_study_id