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

NCT03639857 | Terminated Results FDA Device

• 1 other identifier: BIO-17-13680
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Cutaneous Lupus

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

532nm laser and topical corticosteroid

EXPERIMENTAL

532nm laser is applied to the patient's lesion in-clinic in addition to a topical corticosteroid.

Device: 532nm laser; Drug: Topical corticosteroid

1064nm laser and topical corticosteroid

EXPERIMENTAL

1064nm laser is applied to the patient's lesion in-clinic in addition to a topical corticosteroid.

Device: 1064nm laser; Drug: Topical corticosteroid

Topical corticosteroid alone

ACTIVE COMPARATOR

Topical corticosteroid is applied to the patient's lesion.

Drug: Topical corticosteroid

Interventions

532nm laser DEVICE

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

532nm laser and topical corticosteroid

1064nm laser DEVICE

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

1064nm laser and topical corticosteroid

Topical corticosteroid DRUG

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

1064nm laser and topical corticosteroid; 532nm laser and topical corticosteroid; Topical corticosteroid alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• David Weinstein: lead

Study Sites (1)

UCF Health Lake Nona Office

Orlando, Florida, 32827, United States

Location

MeSH Terms

Interventions

Lasers; Adrenal Cortex Hormones

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Dr. David Weinstein
• Organization: University of Central Florida College of Medicine

david.weinstein@ucf.edu

407-266-4900

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Dermatology

Study Record Dates

• First Submitted: August 17, 2018
• First Posted: August 21, 2018
• Study Start: August 17, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: July 21, 2021
• Results First Posted: July 21, 2021

Record last verified: 2021-06

Locations

US (1)