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

May 15, 2021 updated by: Qianjin Lu, MD, PhD, Second Xiangya Hospital of Central South University

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Human
      • Changsha, Human, China, 410011
        • Recruiting
        • The Second Xiangya Hospital of Central South University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Five-Point Telangiectasia Scale after 4, 8, and 24 weeks, respectively.
Time Frame: 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.
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
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.
Time Frame: 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.
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 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.
Time Frame: 4, 8, 12, and 24 weeks
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.
Time Frame: 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
4, 8, 12, 16, and 36 weeks
Change of SLEDAI scores after 12 and 24 weeks, respectively
Time Frame: 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.
12 and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Xiangya Hospital of Central South University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Anticipated)

July 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

January 17, 2021

First Submitted That Met QC Criteria

January 17, 2021

First Posted (Actual)

January 22, 2021

Study Record Updates

Last Update Posted (Actual)

May 18, 2021

Last Update Submitted That Met QC Criteria

May 15, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SecondXHCSU-PFK2020SLE01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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