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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT03178188 |
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Date of registration:
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02/06/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy of 595 nm Pulsed-dye Laser in Treatment of Discoid Lupus Erythematosus
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Scientific 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 |
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Date of first enrolment:
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December 15, 2016 |
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Target sample size:
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24 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03178188 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Thailand
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Contacts
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Name:
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Pawinee Rerknimitr, MD |
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Address:
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Telephone:
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Email:
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pawineererk@yahoo.co.th |
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Affiliation:
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Name:
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Pawinee Rerknimitr, MD, MSc |
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Address:
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Telephone:
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+6622564253 |
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Email:
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pawineererk@yahoo.co.th |
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Affiliation:
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Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Lupus Erythematosus, Discoid
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Intervention(s)
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Device: Sham
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Device: Pulsed-dye Laser
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Primary Outcome(s)
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erythema index (EI)
[Time Frame: week 0(baseline), 4, 8, 12, 16, 24]
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Secondary Outcome(s)
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texture index (TI)
[Time Frame: week 0, 4, 8, 12, 16, 24]
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Physician Global Assessment (PGA) scores
[Time Frame: week 0, 4, 8, 12, 16, 24]
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modified Cutaneous Lupus Erythematosus Disease Area and Severity Index(mCLASI)
[Time Frame: week 0, 4, 8, 12, 16, 24]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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