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

NCT03178188 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2017-06-06

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Chulalongkorn University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-12-15
Primary Completion
2017-12-14
Completion
2017-12-14

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03178188 on ClinicalTrials.gov