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

Primary Purpose

Facial Telangiectasia in Patients With Systemic Lupus Erythematosus

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Intense pulsed light (IPL) treatment
Sponsored by
Second Xiangya Hospital of Central South University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Facial Telangiectasia in Patients With Systemic Lupus Erythematosus focused on measuring Systemic lupus erythematosus, Intense pulsed light, Facial telangiectasia, corticosteroids

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Second Xiangya Hospital of Central South UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

IPL-treated side

Control side

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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
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.

Full Information

First Posted
January 17, 2021
Last Updated
May 15, 2021
Sponsor
Second Xiangya Hospital of Central South University
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1. Study Identification

Unique Protocol Identification Number
NCT04717583
Brief Title
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

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Second Xiangya Hospital of Central South University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Facial Telangiectasia in Patients With Systemic Lupus Erythematosus
Keywords
Systemic lupus erythematosus, Intense pulsed light, Facial telangiectasia, corticosteroids

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IPL-treated side
Arm Type
Experimental
Arm Description
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.
Arm Title
Control side
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Intense pulsed light (IPL) treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of Five-Point Telangiectasia Scale after three times of IPL treatment
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change of Five-Point Telangiectasia Scale after 4, 8, and 24 weeks, respectively.
Description
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.
Time Frame
4, 8, and 24 weeks
Title
Change of Clinician's Erythema Assessment (CEA) scores after a 4-, 8-, 12- and 24-week treatment, respectively.
Description
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.
Time Frame
4, 8, 12, and 24 weeks
Title
Change of Patient Global Assessment (PGA) after a 4-, 8-, 12- and 24-week treatment, respectively.
Description
PGA refers to the subject's global assessment of the facial telangiectasia condition. Change of PGA from baseline to post-treatment will be determined.
Time Frame
4, 8, 12, and 24 weeks
Title
Change of Dermatology Life Quality Index (DLQI) scores after a 4-, 8-, 12-, and 24-week of treatment, respectively.
Description
Change of DLQI from baseline to post-treatment will be determined.
Time Frame
4, 8, 12, and 24 weeks
Title
Change of Skindex-16 scores after a 4-, 8-, 12- and 24-week of treatment, respectively.
Description
Change of Skindex-16 from baseline to post-treatment will be determined.
Time Frame
4, 8, 12, and 24 weeks
Title
The safety evaluation about the adverse reactions throughout the entire study process.
Description
The possible adverse reactions of IPL include rash, pain, short-term pigmentation, recurrence of telangitic erythema, recurrence or aggravation of SLE
Time Frame
4, 8, 12, 16, and 36 weeks
Title
Change of SLEDAI scores after 12 and 24 weeks, respectively
Description
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.
Time Frame
12 and 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qianjin Lu
Phone
13787097676
Email
qianlu5860@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hai Long
Phone
18229743206
Email
dr.hailong@csu.edu.cn
Facility Information:
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Human
ZIP/Postal Code
410011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hai Long, MD, PhD
Phone
18229743206
Email
dr.hailong@csu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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