Trial Outcomes & Findings for Study of the Efficacy of 532nm Laser and 1064 nm Laser in the Treatment of Cutaneous Lupus Erythematous Versus Topical Corticosteroids Alone (NCT NCT03639857)

Results Overview

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

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

3 participants

Primary outcome timeframe

2 Months

Results posted on

2021-07-21

Participant Flow

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

Unit of analysis: Lesions

Participant milestones

Participant milestones
Measure	532nm Laser and Topical Corticosteroid 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 and Topical Corticosteroid 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 Alone 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.
Overall Study STARTED	1 1	3 3	3 3
Overall Study COMPLETED	1 1	3 3	3 3
Overall Study NOT COMPLETED	0 0	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=7 Lesions 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
Age, Categorical <=18 years	0 Participants n=3 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=3 Participants
Age, Categorical >=65 years	0 Participants n=3 Participants
Sex: Female, Male Female	3 Participants n=3 Participants
Sex: Female, Male Male	0 Participants n=3 Participants
Region of Enrollment United States	3 participants n=3 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	532nm Laser and Topical Corticosteroid n=1 Participants 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 and Topical Corticosteroid n=3 Participants 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 Alone n=3 Participants 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.
Limited CLASI Baseline	5 score on a scale Interval 5.0 to 5.0	4 score on a scale Interval 2.0 to 5.0	4.3 score on a scale Interval 3.0 to 6.0
Limited CLASI 1 Month	5 score on a scale Interval 5.0 to 5.0	3.66 score on a scale Interval 2.0 to 5.0	4 score on a scale Interval 3.0 to 5.0
Limited CLASI 2 Months	5 score on a scale Interval 5.0 to 5.0	3.66 score on a scale Interval 2.0 to 6.0	4.33 score on a scale Interval 3.0 to 6.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	532nm Laser and Topical Corticosteroid n=1 Participants 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 and Topical Corticosteroid n=3 Participants 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 Alone n=3 Participants 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.
VAS for Appearance Baseline	7.5 score on a scale Interval 7.5 to 7.5	3.2 score on a scale Interval 1.4 to 6.3	4.2 score on a scale Interval 1.8 to 5.5
VAS for Appearance 1 Month	10 score on a scale Interval 10.0 to 10.0	7.5 score on a scale Interval 6.4 to 9.0	5.5 score on a scale Interval 3.5 to 8.0
VAS for Appearance 2 Months	9 score on a scale Interval 9.0 to 9.0	6.5 score on a scale Interval 4.0 to 7.8	3.6 score on a scale Interval 2.0 to 5.5

PRIMARY outcome

Timeframe: 1 Month

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

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.

Outcome measures

Outcome measures
Measure	532nm Laser and Topical Corticosteroid n=1 Participants 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 and Topical Corticosteroid n=3 Participants 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 Alone 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.
VAS for Pain Baseline	1.4 score on a scale Interval 1.4 to 1.4	3.1 score on a scale Interval 0.0 to 5.0	—
VAS for Pain 1 Month	6 score on a scale Interval 6.0 to 6.0	2.13 score on a scale Interval 1.0 to 3.1	—

Adverse Events

532nm Laser and Topical Corticosteroid

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

1064nm Laser and Topical Corticosteroid

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Topical Corticosteroid Alone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. David Weinstein

University of Central Florida College of Medicine

Phone: 407-266-4900

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place