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

Chulalongkorn University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Lupus Erythematosus, Discoid

Treatments: Device: Pulsed-dye Laser; Device: Sham

Study type: Interventional

Funder types: Other

Identifiers

NCT03178188

1/59

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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24 participants in 2 patient groups

laser treated DLE lesions

Experimental group

Description:

DLE which received the pulsed-dye laser

Treatment:

Device: Pulsed-dye Laser

sham treated DLE lesions

Sham Comparator group

Description:

DLE which received the sham

Treatment:

Device: Sham