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

Phase 2

• Conditions: Lupus Erythematosus, Discoid
• Interventions: Device: Sham; Device: Pulsed-dye Laser

• Registration Number: NCT03178188
• Lead Sponsor: Chulalongkorn University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-15
• Status Verified: 2017-06
• Study First Submitted: 2017-06-02
• Study First Submitted QC: 2017-06-05
• Last Update Submitted: 2017-06-05
• Study First Posted: 2017-06-06
• Last Update Posted: 2017-06-06
• Primary Completion: 2017-12-14
• Study Completion: 2017-12-14

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sham treated DLE lesions	Sham	DLE which received the sham
laser treated DLE lesions	Pulsed-dye Laser	DLE which received the pulsed-dye laser

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
modified Cutaneous Lupus Erythematosus Disease Area and Severity Index(mCLASI)	week 0, 4, 8, 12, 16, 24	Comparing changes of mCLASI from baseline between treated group and controlled group, measured by 1-blinded dermatologist
Physician Global Assessment (PGA) scores	week 0, 4, 8, 12, 16, 24	Comparing overall improvement changes from baseline (PGA scores) measured by 3-blinded dermatologist
texture index (TI)	week 0, 4, 8, 12, 16, 24	Comparing changes of TI from baseline between treated group and controlled group, measured by Antera 3D camera

Trial Locations

Locations (1)

Division of Dermatology, Faculty of Medicine, Chulalongkorn University; 🇹🇭 Bangkok, Thailand