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

• Sponsor: David Weinstein (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03639857
• Collaborator: (none)
• Enrollment: 3
• Location: 1
• Arms: 3
• Actual Duration (Months): 16.5
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cutaneous Lupus	Device: 532nm laser; Device: 1064nm laser; Drug: Topical corticosteroid	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 3 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Aug 17, 2018
• Actual Primary Completion Date: Dec 31, 2019
• Actual Study Completion Date: Dec 31, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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 a

2. VAS 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.

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCF Health Lake Nona Office	Orlando	Florida	United States	32827

Sponsors and Collaborators

• David Weinstein

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 22, 2019
• Informed Consent Form - May 22, 2019

More Information

Publications

None provided.

• Responsible Party: David Weinstein, Assistant Professor of Dermatology, University of Central Florida
• ClinicalTrials.gov Identifier: NCT03639857
• Other Study ID Numbers: BIO-17-13680
• First Posted: Aug 21, 2018
• Last Update Posted: Jul 21, 2021
• Last Verified: Jun 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes

Study Results

Participant Flow

Pre-assignment Detail	We had planned to enroll 7 participants but due to lack of resources/support the study ended early with only 3 participants.

Arm/Group Title	532nm Laser and Topical Corticosteroid	1064nm Laser and Topical Corticosteroid	Topical Corticosteroid Alone
Arm/Group Description	532nm laser is applied to the patient's lesion in-clinic in addition to a topical corticosteroid. 532nm laser: 532nm laser will be used to treat the lesion in this study arm. Topical corticosteroid: The topical corticosteroid will be used to treat the lesion in this study arm.	1064nm laser is applied to the patient's lesion in-clinic in addition to a topical corticosteroid. 1064nm laser: 1064nm laser will be used to treat the lesion in this study arm. Topical corticosteroid: The topical corticosteroid will be used to treat the lesion in this study arm.	Topical corticosteroid is applied to the patient's lesion. Topical corticosteroid: The topical corticosteroid will be used to treat the lesion in this study arm.
Period Title: Overall Study
STARTED	1	3	3
COMPLETED	1	3	3
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	All Study Participants
Arm/Group Description	All study participants received treatment of 2 or 3 lesions of cutaneous lupus depending upon their skin type. Participants with skin type 1, 2 or 3 received treatment of 3 lesions: One lesion treated with 532nm laser One lesion treated with the 1064nm laser One lesion treated with topical corticosteroid Participants with skin type 4, 5 or 6 received treatment of 2 lesions One lesion treated with the 1064nm laser One lesion treated with topical corticosteroid
Overall Participants	3
Overall Lesions	7
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	3 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	3 100%
Male	0 0%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United States	3 100%

Outcome Measures

1. Primary Outcome

Title	Limited CLASI
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	532nm Laser and Topical Corticosteroid	1064nm Laser and Topical Corticosteroid	Topical Corticosteroid Alone
Arm/Group Description	532nm laser is applied to the patient's lesion in-clinic in addition to a topical corticosteroid. 532nm laser: 532nm laser will be used to treat the lesion in this study arm. Topical corticosteroid: The topical corticosteroid will be used to treat the lesion in this study arm.	1064nm laser is applied to the patient's lesion in-clinic in addition to a topical corticosteroid. 1064nm laser: 1064nm laser will be used to treat the lesion in this study arm. Topical corticosteroid: The topical corticosteroid will be used to treat the lesion in this study arm.	Topical corticosteroid is applied to the patient's lesion. Topical corticosteroid: The topical corticosteroid will be used to treat the lesion in this study arm.
Measure Participants	1	3	3
Baseline	5	4	4.3
1 Month	5	3.66	4
2 Months	5	3.66	4.33

2. Primary Outcome

Title	VAS for Appearance
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	532nm Laser and Topical Corticosteroid	1064nm Laser and Topical Corticosteroid	Topical Corticosteroid Alone
Arm/Group Description	532nm laser is applied to the patient's lesion in-clinic in addition to a topical corticosteroid. 532nm laser: 532nm laser will be used to treat the lesion in this study arm. Topical corticosteroid: The topical corticosteroid will be used to treat the lesion in this study arm.	1064nm laser is applied to the patient's lesion in-clinic in addition to a topical corticosteroid. 1064nm laser: 1064nm laser will be used to treat the lesion in this study arm. Topical corticosteroid: The topical corticosteroid will be used to treat the lesion in this study arm.	Topical corticosteroid is applied to the patient's lesion. Topical corticosteroid: The topical corticosteroid will be used to treat the lesion in this study arm.
Measure Participants	1	3	3
Baseline	7.5	3.2	4.2
1 Month	10	7.5	5.5
2 Months	9	6.5	3.6

3. Primary Outcome

Title	VAS for Pain
Description	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

Outcome Measure Data

Analysis Population Description

The control arm did not receive any laser intervention, just a topical medication therefore the pain scale was not used.

Arm/Group Title	532nm Laser and Topical Corticosteroid	1064nm Laser and Topical Corticosteroid	Topical Corticosteroid Alone
Arm/Group Description	532nm laser is applied to the patient's lesion in-clinic in addition to a topical corticosteroid. 532nm laser: 532nm laser will be used to treat the lesion in this study arm. Topical corticosteroid: The topical corticosteroid will be used to treat the lesion in this study arm.	1064nm laser is applied to the patient's lesion in-clinic in addition to a topical corticosteroid. 1064nm laser: 1064nm laser will be used to treat the lesion in this study arm. Topical corticosteroid: The topical corticosteroid will be used to treat the lesion in this study arm.	Topical corticosteroid is applied to the patient's lesion. Topical corticosteroid: The topical corticosteroid will be used to treat the lesion in this study arm.
Measure Participants	1	3	0
Baseline	1.4	3.1
1 Month	6	2.13

Adverse Events

Time Frame	Adverse Events and All-Cause Mortality were assessed for 8 weeks of treatment and 1 month after for follow-up.
Adverse Event Reporting Description	This was only a moderate risk study for the participants as only a lower energy laser was used on the skin.
Arm/Group Title	532nm Laser and Topical Corticosteroid		1064nm Laser and Topical Corticosteroid		Topical Corticosteroid Alone
Arm/Group Description	532nm laser is applied to the patient's lesion in-clinic in addition to a topical corticosteroid. 532nm laser: 532nm laser will be used to treat the lesion in this study arm. Topical corticosteroid: The topical corticosteroid will be used to treat the lesion in this study arm.		1064nm laser is applied to the patient's lesion in-clinic in addition to a topical corticosteroid. 1064nm laser: 1064nm laser will be used to treat the lesion in this study arm. Topical corticosteroid: The topical corticosteroid will be used to treat the lesion in this study arm.		Topical corticosteroid is applied to the patient's lesion. Topical corticosteroid: The topical corticosteroid will be used to treat the lesion in this study arm.
All Cause Mortality
	532nm Laser and Topical Corticosteroid		1064nm Laser and Topical Corticosteroid		Topical Corticosteroid Alone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/3 (0%)		0/3 (0%)
Serious Adverse Events
	532nm Laser and Topical Corticosteroid		1064nm Laser and Topical Corticosteroid		Topical Corticosteroid Alone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/3 (0%)		0/3 (0%)
Other (Not Including Serious) Adverse Events
	532nm Laser and Topical Corticosteroid		1064nm Laser and Topical Corticosteroid		Topical Corticosteroid Alone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/3 (0%)		0/3 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.