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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 532nm laser and topical corticosteroid | Experimental | 532nm laser is applied to the patient's lesion in-clinic in addition to a topical corticosteroid. |
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| 1064nm laser and topical corticosteroid | Experimental | 1064nm laser is applied to the patient's lesion in-clinic in addition to a topical corticosteroid. |
|
| Topical corticosteroid alone | Active Comparator | Topical corticosteroid is applied to the patient's lesion. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 532nm laser | Device | 532nm laser will be used to treat the lesion in this study arm. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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:
The limited damage CLASI for a lesion will include the following:
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCF Health Lake Nona Office | Orlando | Florida | 32827 | United States |
We had planned to enroll 7 participants but due to lack of resources/support the study ended early with only 3 participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 22, 2019 |
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| 1064nm laser | Device | 1064nm laser will be used to treat the lesion in this study arm. |
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| Topical corticosteroid | Drug | The topical corticosteroid will be used to treat the lesion in this study arm. |
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| 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. |
| FG002 | 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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:
Participants with skin type 4, 5 or 6 received treatment of 2 lesions
|
| Units | Counts |
|---|---|
| Participants |
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| Lesions |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants | Participants |
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| ||||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
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| Region of Enrollment | Number | participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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:
The limited damage CLASI for a lesion will include the following:
| Posted | Mean | Full Range | score on a scale | 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. | Posted | Mean | Full Range | score on a scale | 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. | The control arm did not receive any laser intervention, just a topical medication therefore the pain scale was not used. | Posted | Mean | Full Range | score on a scale | 1 Month |
|
Adverse Events and All-Cause Mortality were assessed for 8 weeks of treatment and 1 month after for follow-up.
This was only a moderate risk study for the participants as only a lower energy laser was used on the skin.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 1 | 0 | 1 | 0 | 1 |
| EG001 | 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. | 0 | 3 | 0 | 3 | 0 | 3 |
| EG002 | 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. | 0 | 3 | 0 | 3 | 0 | 3 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Weinstein | University of Central Florida College of Medicine | 407-266-4900 | david.weinstein@ucf.edu |
| Jun 29, 2021 |
| Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 22, 2019 | Jun 29, 2021 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D007834 | Lasers |
| D000305 | Adrenal Cortex Hormones |
| ID | Term |
|---|---|
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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| Title | Measurements |
|---|---|
| Female |
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| Male |
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| Title | Measurements |
|---|---|
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| 2 Months |
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