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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| laser treated DLE lesions | Experimental | DLE which received the pulsed-dye laser |
|
| sham treated DLE lesions | Sham Comparator | DLE which received the sham |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulsed-dye Laser | 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 |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pawinee Rerknimitr, MD | Contact | pawineererk@yahoo.co.th |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Dermatology, Faculty of Medicine, Chulalongkorn University | Recruiting | Bangkok | 10330 | Thailand |
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| ID | Term |
|---|---|
| D008179 | Lupus Erythematosus, Discoid |
| ID | Term |
|---|---|
| D008178 | Lupus Erythematosus, Cutaneous |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D054025 | Lasers, Dye |
| ID | Term |
|---|---|
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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| Sham | Device | Cryogen spray with the setting of dynamic cooling device 30/20 |
|
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 |