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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-15

Study Completion Date

2017-12-14

Brief Summary

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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.

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Detailed Description

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Conditions

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Lupus Erythematosus, Discoid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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laser treated DLE lesions

DLE which received the pulsed-dye laser

Group Type EXPERIMENTAL

Pulsed-dye Laser

Intervention Type DEVICE

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 treated DLE lesions

DLE which received the sham

Group Type SHAM_COMPARATOR

Sham

Intervention Type DEVICE

Cryogen spray with the setting of dynamic cooling device 30/20

Interventions

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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

Intervention Type DEVICE

Sham

Cryogen spray with the setting of dynamic cooling device 30/20

Intervention Type DEVICE

Eligibility Criteria

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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