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

Cutaneous Lupus Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03639857
• Other study ID #: BIO-17-13680
• Status: Terminated
• Phase: N/A
• Start date: August 17, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: June 2021
• Source: University of Central Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cutaneous Lupus

Intervention

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

Locations

Country	Name	City	State
United States	UCF Health Lake Nona Office	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
David Weinstein

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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