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

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ClinicalTrials.gov Identifier: NCT03178188
Recruitment Status : Unknown
Verified June 2017 by Pawinee Rerknimitr, Chulalongkorn University.
Recruitment status was:  Recruiting
First Posted : June 6, 2017
Last Update Posted : June 6, 2017
Sponsor:
Information provided by (Responsible Party):
Pawinee Rerknimitr, Chulalongkorn University

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
Lupus Erythematosus, Discoid Device: Pulsed-dye Laser Device: Sham Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of 595 nm Pulsed-dye Laser as an Adjunctive Treatment of Discoid Lupus Erythematosus, A Randomized, Patient/Assessor Blinded Placebo Control Trial
Actual Study Start Date : December 15, 2016
Estimated Primary Completion Date : December 14, 2017
Estimated Study Completion Date : December 14, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

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




Primary Outcome Measures :
  1. erythema index (EI) [ Time Frame: 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 :
  1. modified Cutaneous Lupus Erythematosus Disease Area and Severity Index(mCLASI) [ Time Frame: week 0, 4, 8, 12, 16, 24 ]
    Comparing changes of mCLASI from baseline between treated group and controlled group, measured by 1-blinded dermatologist

  2. Physician Global Assessment (PGA) scores [ Time Frame: week 0, 4, 8, 12, 16, 24 ]
    Comparing overall improvement changes from baseline (PGA scores) measured by 3-blinded dermatologist

  3. texture index (TI) [ Time Frame: week 0, 4, 8, 12, 16, 24 ]
    Comparing changes of TI from baseline between treated group and controlled group, measured by Antera 3D camera



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03178188


Contacts
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Contact: Pawinee Rerknimitr, MD pawineererk@yahoo.co.th

Locations
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Thailand
Division of Dermatology, Faculty of Medicine, Chulalongkorn University Recruiting
Bangkok, Thailand, 10330
Contact: Pawinee Rerknimitr, MD, MSc    +6622564253    pawineererk@yahoo.co.th   
Sponsors and Collaborators
Chulalongkorn University

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Responsible Party: Pawinee Rerknimitr, Assistant Professor, Chulalongkorn University
ClinicalTrials.gov Identifier: NCT03178188     History of Changes
Other Study ID Numbers: 1/59
First Posted: June 6, 2017    Key Record Dates
Last Update Posted: June 6, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pawinee Rerknimitr, Chulalongkorn University:
lupus erythematosus, Discoid
Pulsed-dye Laser
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Lupus Erythematosus, Discoid
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Lupus Erythematosus, Cutaneous
Skin Diseases