Efficacy of 595 nm Pulsed-dye Laser in Treatment of Discoid Lupus Erythematosus
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: laser treated DLE lesions DLE which received the pulsed-dye laser |
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
|
| Sham Comparator: sham treated DLE lesions DLE which received the sham |
Device: Sham
Cryogen spray with the setting of dynamic cooling device 30/20
|
Outcome Measures
Primary Outcome Measures
- erythema index (EI) [week 0(baseline), 4, 8, 12, 16, 24]
Comparing changes of EI from baseline between treated group and controlled group, measured by Antera 3D camera
Secondary Outcome Measures
- modified Cutaneous Lupus Erythematosus Disease Area and Severity Index(mCLASI) [week 0, 4, 8, 12, 16, 24]
Comparing changes of mCLASI from baseline between treated group and controlled group, measured by 1-blinded dermatologist
- Physician Global Assessment (PGA) scores [week 0, 4, 8, 12, 16, 24]
Comparing overall improvement changes from baseline (PGA scores) measured by 3-blinded dermatologist
- texture index (TI) [week 0, 4, 8, 12, 16, 24]
Comparing changes of TI from baseline between treated group and controlled group, measured by Antera 3D camera
Eligibility Criteria
Criteria
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
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Dose not undergo any procedure or laser treatment within 4 weeks before entered the study
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Dose not received any localised therapy of DLE eg. topical corticosteriod/immunomodulator within 4 weeks before entered the study
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Dose not receive the topical chemical peeling within 4 weeks before entered the study
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Has already received at least 1 systemic standard treatment for DLE and continue until the rest of the study
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Can follow the study's protocol
Exclusion Criteria:
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Pregnancy or lactation
-
History of skin cancer
-
History of photo allergy
-
History of bleeding tendency
-
History of abnormal wound healing
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Division of Dermatology, Faculty of Medicine, Chulalongkorn University | Bangkok | Thailand | 10330 |
Sponsors and Collaborators
- Chulalongkorn University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1/59