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

Efficacy of 595 nm Pulsed-dye Laser as an Adjunctive Treatment of Discoid Lupus Erythematosus, A Randomized, Patient/Assessor Blinded Placebo Control Trial

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.

Study Overview

• Status: Unknown
• Conditions: Lupus Erythematosus, Discoid
• Intervention / Treatment: Device: Pulsed-dye Laser; Device: Sham

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Pawinee Rerknimitr, MD; Email: pawineererk@yahoo.co.th

Study Locations

• Thailand
  • Bangkok, Thailand, 10330
    • Recruiting
    • Division of Dermatology, Faculty of Medicine, Chulalongkorn University
    • Contact: Pawinee Rerknimitr, MD, MSc; Phone Number: +6622564253; Email: pawineererk@yahoo.co.th

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: laser treated DLE lesions; DLE which received the pulsed-dye laser	Device: Pulsed-dye Laser; 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
Sham Comparator: sham treated DLE lesions; DLE which received the sham	Device: Sham; Cryogen spray with the setting of dynamic cooling device 30/20

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
erythema index (EI)	Comparing changes of EI from baseline between treated group and controlled group, measured by Antera 3D camera	week 0(baseline), 4, 8, 12, 16, 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	week 0, 4, 8, 12, 16, 24
Physician Global Assessment (PGA) scores	Comparing overall improvement changes from baseline (PGA scores) measured by 3-blinded dermatologist	week 0, 4, 8, 12, 16, 24
texture index (TI)	Comparing changes of TI from baseline between treated group and controlled group, measured by Antera 3D camera	week 0, 4, 8, 12, 16, 24

Collaborators and Investigators

• Sponsor: Chulalongkorn University

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2016
• Primary Completion (Anticipated): December 14, 2017
• Study Completion (Anticipated): December 14, 2017

Study Registration Dates

• First Submitted: June 2, 2017
• First Submitted That Met QC Criteria: June 5, 2017
• First Posted (Actual): June 6, 2017

Study Record Updates

• Last Update Posted (Actual): June 6, 2017
• Last Update Submitted That Met QC Criteria: June 5, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: lupus erythematosus, Discoid; Pulsed-dye Laser
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Cutaneous; Lupus Erythematosus, Systemic; Lupus Erythematosus, Discoid
• Other Study ID Numbers: 1/59

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