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NCT03178188

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

Status unknown Phase 2, PHASE3 Last updated 6 June 2017
What this trial tests

Phase 2, PHASE3 trial testing Pulsed-dye Laser in Lupus Erythematosus, Discoid in 24 participants. Status unknown.

Timeline
15 December 2016
Primary endpoint
14 December 2017
14 December 2017

Quick facts

Lead sponsorChulalongkorn University
PhasePhase 2, PHASE3
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment24
Start date15 December 2016
Primary completion14 December 2017
Estimated completion14 December 2017
Sites1 location across Thailand

Drugs / interventions tested

Conditions studied

Sponsor

Chulalongkorn University

Who can join

18 and older, any sex, with Lupus Erythematosus, Discoid. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Lupus Erythematosus, Discoid

Currently open trials in the same condition.

Other Chulalongkorn University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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