NCT03178188

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Chulalongkorn University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Lupus Erythematosus, Discoid

Interventions

Type	Name	Description
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
DEVICE	Sham	Cryogen spray with the setting of dynamic cooling device 30/20

Timeline

• Start date: 2016-12-15
• Primary completion: 2017-12-14
• Completion: 2017-12-14
• First posted: 2017-06-06
• Last updated: 2017-06-06

Locations

1 site across 1 country: Thailand