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

Study Overview
=================
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.

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

Conditions
-----------------
Cutaneous Lupus

Intervention / Treatment
-----------------
* Device: 532nm laser
* Device: 1064nm laser
* Drug: Topical corticosteroid


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 532nm laser and topical corticosteroid<br>532nm laser is applied to the patient's lesion in-clinic in addition to a topical corticosteroid. | Device: 532nm laser<br>* 532nm laser will be used to treat the lesion in this study arm.<br>Drug: Topical corticosteroid<br>* The topical corticosteroid will be used to treat the lesion in this study arm.<br>|
| Experimental: 1064nm laser and topical corticosteroid<br>1064nm laser is applied to the patient's lesion in-clinic in addition to a topical corticosteroid. | Device: 1064nm laser<br>* 1064nm laser will be used to treat the lesion in this study arm.<br>Drug: Topical corticosteroid<br>* The topical corticosteroid will be used to treat the lesion in this study arm.<br>|
| Active Comparator: Topical corticosteroid alone<br>Topical corticosteroid is applied to the patient's lesion. | Drug: Topical corticosteroid<br>* The topical corticosteroid will be used to treat the lesion in this study arm.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 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. | 1 Month |