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Efficacy of 595 nm Pulsed-dye Laser in Treatment of Discoid Lupus Erythematosus

Primary Purpose

Lupus Erythematosus, Discoid

Status
Unknown status
Phase
Phase 2
Locations
Thailand
Study Type
Interventional
Intervention
Pulsed-dye Laser
Sham
Sponsored by
Chulalongkorn University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lupus Erythematosus, Discoid focused on measuring lupus erythematosus, Discoid, Pulsed-dye Laser

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age > 18 years
  • Has at least two DLE lesions, located in the same anatomical location of the body, which the different of mCLASI are not more than 1 point
  • Dose not undergo any procedure or laser treatment within 4 weeks before entered the study
  • Dose not received any localised therapy of DLE eg. topical corticosteriod/immunomodulator within 4 weeks before entered the study
  • Dose not receive the topical chemical peeling within 4 weeks before entered the study
  • Has already received at least 1 systemic standard treatment for DLE and continue until the rest of the study
  • Can follow the study's protocol

Exclusion Criteria:

  • Pregnancy or lactation
  • History of skin cancer
  • History of photo allergy
  • History of bleeding tendency
  • History of abnormal wound healing

Sites / Locations

  • Division of Dermatology, Faculty of Medicine, Chulalongkorn UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

laser treated DLE lesions

sham treated DLE lesions

Arm Description

DLE which received the pulsed-dye laser

DLE which received the sham

Outcomes

Primary Outcome Measures

erythema index (EI)
Comparing changes of EI from baseline between treated group and controlled group, measured by Antera 3D camera

Secondary Outcome Measures

modified Cutaneous Lupus Erythematosus Disease Area and Severity Index(mCLASI)
Comparing changes of mCLASI from baseline between treated group and controlled group, measured by 1-blinded dermatologist
Physician Global Assessment (PGA) scores
Comparing overall improvement changes from baseline (PGA scores) measured by 3-blinded dermatologist
texture index (TI)
Comparing changes of TI from baseline between treated group and controlled group, measured by Antera 3D camera

Full Information

First Posted
June 2, 2017
Last Updated
June 5, 2017
Sponsor
Chulalongkorn University
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1. Study Identification

Unique Protocol Identification Number
NCT03178188
Brief Title
Efficacy of 595 nm Pulsed-dye Laser in Treatment of Discoid Lupus Erythematosus
Official Title
Efficacy of 595 nm Pulsed-dye Laser as an Adjunctive Treatment of Discoid Lupus Erythematosus, A Randomized, Patient/Assessor Blinded Placebo Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 15, 2016 (Actual)
Primary Completion Date
December 14, 2017 (Anticipated)
Study Completion Date
December 14, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chulalongkorn 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
forty DLE lesions from patients will be recruited in the study. The lesions on one side of the body were block-randomized into the treatment group and the other side served as a control. The patients can continue their systemic treatments and the PDL is designed to be used as an adjunctive treatment. Treatments with the PDL will be delivered in the treatment group every 4 weeks for 4 consecutive months while the lesions in the control group received a sham. The patients will be evaluated at baseline (week 0), week 4, 8, 12, and at follow-up period of 4, 12 weeks after the final treatment (week 16, 24). Erythema index (EI), Texture index (TI) will be obtained and digital photographs will be taken and modified Cutaneous Lupus Erythematosus Disease Area and Severity Index (mCLASI) will be assessed in every visit. The digital photographs will later be evaluated by 3-blinded dermatologists. Moreover, side effects and patients' satisfaction score will also be recorded.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Erythematosus, Discoid
Keywords
lupus erythematosus, Discoid, Pulsed-dye Laser

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
laser treated DLE lesions
Arm Type
Experimental
Arm Description
DLE which received the pulsed-dye laser
Arm Title
sham treated DLE lesions
Arm Type
Sham Comparator
Arm Description
DLE which received the sham
Intervention Type
Device
Intervention Name(s)
Pulsed-dye Laser
Intervention Description
595 nm Pulsed-dye Laser; 7mm spot sizes, 6msec pulse durations, 8j/cm2 fluences, dynamic cooling device 30/20, 4 sessions with 4 weeks interval
Intervention Type
Device
Intervention Name(s)
Sham
Intervention Description
Cryogen spray with the setting of dynamic cooling device 30/20
Primary Outcome Measure Information:
Title
erythema index (EI)
Description
Comparing changes of EI from baseline between treated group and controlled group, measured by Antera 3D camera
Time Frame
week 0(baseline), 4, 8, 12, 16, 24
Secondary Outcome Measure Information:
Title
modified Cutaneous Lupus Erythematosus Disease Area and Severity Index(mCLASI)
Description
Comparing changes of mCLASI from baseline between treated group and controlled group, measured by 1-blinded dermatologist
Time Frame
week 0, 4, 8, 12, 16, 24
Title
Physician Global Assessment (PGA) scores
Description
Comparing overall improvement changes from baseline (PGA scores) measured by 3-blinded dermatologist
Time Frame
week 0, 4, 8, 12, 16, 24
Title
texture index (TI)
Description
Comparing changes of TI from baseline between treated group and controlled group, measured by Antera 3D camera
Time Frame
week 0, 4, 8, 12, 16, 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age > 18 years Has at least two DLE lesions, located in the same anatomical location of the body, which the different of mCLASI are not more than 1 point Dose not undergo any procedure or laser treatment within 4 weeks before entered the study Dose not received any localised therapy of DLE eg. topical corticosteriod/immunomodulator within 4 weeks before entered the study Dose not receive the topical chemical peeling within 4 weeks before entered the study Has already received at least 1 systemic standard treatment for DLE and continue until the rest of the study Can follow the study's protocol Exclusion Criteria: Pregnancy or lactation History of skin cancer History of photo allergy History of bleeding tendency History of abnormal wound healing
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pawinee Rerknimitr, MD
Email
pawineererk@yahoo.co.th
Facility Information:
Facility Name
Division of Dermatology, Faculty of Medicine, Chulalongkorn University
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pawinee Rerknimitr, MD, MSc
Phone
+6622564253
Email
pawineererk@yahoo.co.th

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficacy of 595 nm Pulsed-dye Laser in Treatment of Discoid Lupus Erythematosus

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