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Study of the Efficacy of 532nm Laser and 1064 nm Laser in the Treatment of Cutaneous Lupus Erythematous Versus Topical Corticosteroids Alone

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03639857
Recruitment Status : Recruiting
First Posted : August 21, 2018
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
David Weinstein, University of Central Florida

Brief Summary:
This study aims to compare the efficacy of 532nm Potassium Titanyl Phosphate (KTP) laser and 1064 nm Neodymium-doped Yttrium Aluminum Garnet (Nd:YAG) laser as adjuncts to topical corticosteroids in the treatment of cutaneous lupus erythematosus versus topical corticosteroids alone.

Condition or disease Intervention/treatment Phase
Cutaneous Lupus Device: 532nm laser Device: 1064nm laser Drug: Topical corticosteroid Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Comparative Study of the Efficacy of 532nm Laser and 1064 nm Laser in the Treatment of Cutaneous Lupus Erythematous Versus Topical Corticosteroids Alone
Actual Study Start Date : August 17, 2018
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids

Arm Intervention/treatment
Experimental: 532nm laser and topical corticosteroid
532nm laser is applied to the patient's lesion in-clinic in addition to a topical corticosteroid.
Device: 532nm laser
532nm laser will be used to treat the lesion in this study arm.

Drug: Topical corticosteroid
The topical corticosteroid will be used to treat the lesion in this study arm.

Experimental: 1064nm laser and topical corticosteroid
1064nm laser is applied to the patient's lesion in-clinic in addition to a topical corticosteroid.
Device: 1064nm laser
1064nm laser will be used to treat the lesion in this study arm.

Drug: Topical corticosteroid
The topical corticosteroid will be used to treat the lesion in this study arm.

Active Comparator: Topical corticosteroid alone
Topical corticosteroid is applied to the patient's lesion.
Drug: Topical corticosteroid
The topical corticosteroid will be used to treat the lesion in this study arm.




Primary Outcome Measures :
  1. Limited CLASI [ Time Frame: 3 months ]

    The investigators are using a limited CLASI scoring system to classify specific lesions the investigators are measuring. The total limited CLASI reflects the sum of both active and damage CLASI, resulting in a score ranging from 0 to 8.

    The limited active CLASI for a lesion will include the following:

    • Erythema (ranging from 0 = absent to 3 = dark red/purple)
    • Scale/Hypertrophy (ranging from 0 = absent to 2 = verrucous/ hypertrophic)
    • The addition of these scores result in a total limited active CLASI score of the studied lesion, ranging from 0 to 5.

    The limited damage CLASI for a lesion will include the following:

    • Dyspigmentation (0 = absent or 1 = present)
    • Scarring/Atrophy/Panniculitis (ranging from 0 = absent to 2 = severely atrophic scarring or panniculitis).
    • The addition of these scores result in a maximum damage score of 3

  2. VAS for Appearance [ Time Frame: 3 months ]

    The investigators are using a VAS (visual analog scale) to assess both patient and physician assessment of the appearance of the lesion. The scale ranges from 1-10, with 10 being very satisfied and 1 being no satisfaction at all.

    A score of 0 will represent a cosmetically fully unsatisfactory result and 10 will represent cosmetically excellent result.


  3. VAS for Pain [ Time Frame: 8 weeks ]

    The investigators are using a VAS (visual analog scale) to assess pain of the lesion. The scale ranges from 1(no pain) to 10(worse pain).

    A score of 0 will represent absence of pain and 10 will represent maximal pain.




Information from the National Library of Medicine

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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:

  • Male or female adult 18 years of age or older
  • Ability to rate level of pain
  • Ability to rate visual satisfaction
  • At least 2 active lesions of CLE

Exclusion Criteria:

  • New or change in systemic medication for cutaneous lupus in past 6 months
  • Allergy to triamcinolone or betamethasone dipropionate cream
  • Pregnancy
  • Currently a prisoner
  • Unable to read and speak English since consent will only be available in English

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): NCT03639857


Contacts
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Contact: David Weinstein, MD 407-266-4900 david.weinstein@ucf.edu

Locations
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United States, Florida
UCF Health Lake Nona Office Recruiting
Orlando, Florida, United States, 32827
Contact: David Weinstein, MD    407-266-4900    david.weinstein@ucf.edu   
Principal Investigator: David Weinstein, MD         
Sponsors and Collaborators
David Weinstein

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Responsible Party: David Weinstein, Assistant Professor of Dermatology, University of Central Florida
ClinicalTrials.gov Identifier: NCT03639857    
Other Study ID Numbers: BIO-17-13680
First Posted: August 21, 2018    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes