Study of the Efficacy of 532nm Laser and 1064 nm Laser in the Treatment of Cutaneous Lupus Erythematous Versus Topical Corticosteroids Alone
- Conditions
- Cutaneous Lupus
- Interventions
- Device: 532nm laserDrug: Topical corticosteroidDevice: 1064nm laser
- Registration Number
- NCT03639857
- Lead Sponsor
- David Weinstein
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 3
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 532nm laser and topical corticosteroid 532nm laser 532nm laser is applied to the patient's lesion in-clinic in addition to a topical corticosteroid. Topical corticosteroid alone Topical corticosteroid Topical corticosteroid is applied to the patient's lesion. 1064nm laser and topical corticosteroid Topical corticosteroid 1064nm laser is applied to the patient's lesion in-clinic in addition to a topical corticosteroid. 1064nm laser and topical corticosteroid 1064nm laser 1064nm laser is applied to the patient's lesion in-clinic in addition to a topical corticosteroid. 532nm laser and topical corticosteroid Topical corticosteroid 532nm laser is applied to the patient's lesion in-clinic in addition to a topical corticosteroid.
- Primary Outcome Measures
Name Time Method Limited CLASI 2 Months The investigators are using a limited Cutaneous Lupus Erythematosus Disease Area and Severity Index (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. A higher score indicates more severe disease. Score is assessed by the investigators.
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 aVAS for Appearance 2 Months The investigators are using a VAS (visual analog scale) to measure patient assessment of the appearance of the lesion. The scale ranges from 0-10, with 10 being very satisfied and 0 being no satisfaction at all.
A score of 0 will represent a cosmetically fully unsatisfactory result and 10 will represent cosmetically excellent result.VAS for Pain 1 Month The investigators are using a VAS (visual analog scale) to assess pain of the laser treatment. The participant rates the pain of the laser treatment. The scale ranges from 0 (no pain) to 10(worse pain).
A score of 0 will represent absence of pain and 10 will represent maximal pain.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
UCF Health Lake Nona Office
🇺🇸Orlando, Florida, United States