NCT03178188|UnknownPhase 2/3
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Sponsor study identifier
interventional
24
1 country
1
Study Start
December 15, 2016
Actual (reported)Primary Completion
December 14, 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 14, 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 14, 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 15, 2016
Actual (reported)June 2, 2017
Actual (reported)June 6, 2017
Actual (reported)December 14, 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 14, 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
modified Cutaneous Lupus Erythematosus Disease Area and Severity Index(mCLASI)
week 0, 4, 8, 12, 16, 24
Physician Global Assessment (PGA) scores
week 0, 4, 8, 12, 16, 24
texture index (TI)
week 0, 4, 8, 12, 16, 24
DLE which received the pulsed-dye laser
DLE which received the sham
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
Cryogen spray with the setting of dynamic cooling device 30/20
Division of Dermatology, Faculty of Medicine, Chulalongkorn University
Bangkok, 10330, Thailand
First Submitted
June 2, 2017
First Posted
June 6, 2017
Study Start
December 15, 2016
Actual (reported)Primary Completion
December 14, 2017
Estimated (date passed)Efficacy and Safety of ASF-1096 Cream 0.5% in the Treatment of Discoid Lupus Erythematosus (DLE) Lesions
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 14, 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 6, 2017
Record last verified: 2017-06
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Source: ClinicalTrials.gov.
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