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

Study Overview
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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.

Official Title
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Efficacy of 595 nm Pulsed-dye Laser as an Adjunctive Treatment of Discoid Lupus Erythematosus, A Randomized, Patient/Assessor Blinded Placebo Control Trial

Conditions
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Lupus Erythematosus, Discoid

Intervention / Treatment
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* Device: Pulsed-dye Laser
* Device: Sham


Participation Criteria
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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 Exclusion Criteria: Pregnancy or lactation History of skin cancer History of photo allergy History of bleeding tendency History of abnormal wound healing

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: laser treated DLE lesions<br>DLE which received the pulsed-dye laser | Device: Pulsed-dye Laser<br>* 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<br>|
| Sham Comparator: sham treated DLE lesions<br>DLE which received the sham | Device: Sham<br>* Cryogen spray with the setting of dynamic cooling device 30/20<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| erythema index (EI) | Comparing changes of EI from baseline between treated group and controlled group, measured by Antera 3D camera | week 0(baseline), 4, 8, 12, 16, 24 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lupus erythematosus, Discoid, Pulsed-dye Laser