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

David Weinstein3 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cutaneous Lupus

Interventions

532nm laserDEVICE

532nm laser will be used to treat the lesion in this study arm.

1064nm laserDEVICE

1064nm laser will be used to treat the lesion in this study arm.

Topical corticosteroidDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

UCF Health Lake Nona Office

Orlando, Florida, United States

Outcomes

Primary Outcomes

Limited CLASI

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 a

Time frame: 2 Months

VAS for Appearance

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.

Time frame: 2 Months

VAS for Pain

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.

Time frame: 1 Month

Data from ClinicalTrials.gov

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