Cutaneous Lupus
Conditions
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.
Interventions
DEVICE532nm laser
532nm laser will be used to treat the lesion in this study arm.
DEVICE1064nm laser
1064nm laser will be used to treat the lesion in this study arm.
The topical corticosteroid will be used to treat the lesion in this study arm.
Sponsors
David Weinstein
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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. |
Countries
United States
Participant flow
Pre-assignment details
We had planned to enroll 7 participants but due to lack of resources/support the study ended early with only 3 participants.
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants 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 | 3 |
| All Study Participants 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 | 7 |
| Total | 10 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Region of Enrollment United States | 3 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 3 | 0 / 3 |
| other Total, other adverse events | 0 / 1 | 0 / 3 | 0 / 3 |
| serious Total, serious adverse events | 0 / 1 | 0 / 3 | 0 / 3 |
Outcome results
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
Time frame: 2 Months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| 532nm Laser and Topical Corticosteroid | Limited CLASI | 1 Month | 5 score on a scale |
| 532nm Laser and Topical Corticosteroid | Limited CLASI | Baseline | 5 score on a scale |
| 532nm Laser and Topical Corticosteroid | Limited CLASI | 2 Months | 5 score on a scale |
| 1064nm Laser and Topical Corticosteroid | Limited CLASI | 1 Month | 3.66 score on a scale |
| 1064nm Laser and Topical Corticosteroid | Limited CLASI | Baseline | 4 score on a scale |
| 1064nm Laser and Topical Corticosteroid | Limited CLASI | 2 Months | 3.66 score on a scale |
| Topical Corticosteroid Alone | Limited CLASI | Baseline | 4.3 score on a scale |
| Topical Corticosteroid Alone | Limited CLASI | 2 Months | 4.33 score on a scale |
| Topical Corticosteroid Alone | Limited CLASI | 1 Month | 4 score on a scale |
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.
Time frame: 2 Months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| 532nm Laser and Topical Corticosteroid | VAS for Appearance | 1 Month | 10 score on a scale |
| 532nm Laser and Topical Corticosteroid | VAS for Appearance | Baseline | 7.5 score on a scale |
| 532nm Laser and Topical Corticosteroid | VAS for Appearance | 2 Months | 9 score on a scale |
| 1064nm Laser and Topical Corticosteroid | VAS for Appearance | Baseline | 3.2 score on a scale |
| 1064nm Laser and Topical Corticosteroid | VAS for Appearance | 1 Month | 7.5 score on a scale |
| 1064nm Laser and Topical Corticosteroid | VAS for Appearance | 2 Months | 6.5 score on a scale |
| Topical Corticosteroid Alone | VAS for Appearance | Baseline | 4.2 score on a scale |
| Topical Corticosteroid Alone | VAS for Appearance | 2 Months | 3.6 score on a scale |
| Topical Corticosteroid Alone | VAS for Appearance | 1 Month | 5.5 score on a scale |
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.
Time frame: 1 Month
Population: The control arm did not receive any laser intervention, just a topical medication therefore the pain scale was not used.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| 532nm Laser and Topical Corticosteroid | VAS for Pain | Baseline | 1.4 score on a scale |
| 532nm Laser and Topical Corticosteroid | VAS for Pain | 1 Month | 6 score on a scale |
| 1064nm Laser and Topical Corticosteroid | VAS for Pain | Baseline | 3.1 score on a scale |
| 1064nm Laser and Topical Corticosteroid | VAS for Pain | 1 Month | 2.13 score on a scale |