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| Name | Class |
|---|---|
| T-Cellerate LLC | INDUSTRY |
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This study will use Blue-light Photo-therapy to treat patients with psoriasis vulgaris and Grover's Disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult treatment arm | Experimental | Adults enrolled in the study will receive treatment (blue light phototherapy) on one area of their body affected by psoriasis or Grover's disease. The treatment area (restricted by size of the device) will be compared to untreated areas affected by disease on the same patient. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blue light phototherapy | Device | Phototherapy- Wavelength: 417±15 nm |
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| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of Blue Light Therapy for Patients With Grover's Disease | Demonstrate preliminary skin efficacy as measured by lesion count | Time Frame: 5 weeks |
| Assess User Experience With the Dermatology Life Quality Index (DLQI) Pre and Post-treatment. | The DLQI is a questionnaire with 10 questions. The maximum score is 30 and minimum is 0. The higher the score, the more quality of life is impaired. | Time Frame: 5 weeks |
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Inclusion Criteria:
Exclusion Criteria:
All Groups: Subjects who are younger than 18 years of age or older than 90 years of age
Patients who have received topical or systemic treatment within the prior 2 weeks of planned phototherapy
Patients prescribed any of the following drugs for issues not related to their psoriasis or Grover's disease
Unable to schedule phototherapy sessions
We will not recruit the following populations: adults unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant women, prisoners and other vulnerable populations.
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| Name | Affiliation | Role |
|---|---|---|
| Shuai Xu | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University Department of Dermatology | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36449285 | Derived | Olagbenro M, Ravi S, Myers D, Lin D, Woodburn W, Walter JR, Xu S. Assessment of Blue Light Phototherapy for Grover Disease: A Nonrandomized Controlled Trial. JAMA Dermatol. 2023 Jan 1;159(1):102-104. doi: 10.1001/jamadermatol.2022.4491. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Adult Treatment Arm | Adults enrolled in the study will receive treatment (blue light phototherapy) on one area of their body affected by psoriasis or Grover's disease. The treatment area (restricted by size of the device) will be compared to untreated areas affected by disease on the same patient. Blue light phototherapy: Phototherapy- Wavelength: 417±15 nm |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Adult Treatment Arm | Adults enrolled in the study will receive treatment (blue light phototherapy) on one area of their body affected by psoriasis or Grover's disease. The treatment area (restricted by size of the device) will be compared to untreated areas affected by disease on the same patient. Blue light phototherapy: Phototherapy- Wavelength: 417±15 nm |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Efficacy of Blue Light Therapy for Patients With Grover's Disease | Demonstrate preliminary skin efficacy as measured by lesion count | Posted | Mean | 95% Confidence Interval | lesion count | Time Frame: 5 weeks |
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5 weeks
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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 | Adult Treatment Arm | Adults enrolled in the study will receive treatment (blue light phototherapy) on one area of their body affected by psoriasis or Grover's disease. The treatment area (restricted by size of the device) will be compared to untreated areas affected by disease on the same patient. Blue light phototherapy: Phototherapy- Wavelength: 417±15 nm |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dermatology CTU | Northwestern University | 312-503-5944 | NUderm-research@northwestern.edu |
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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 | Jul 26, 2022 | Jan 12, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 2, 2021 | Jan 12, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| C537306 | Grover's disease |
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| ID | Term |
|---|---|
| D010789 | Phototherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Primary | Assess User Experience With the Dermatology Life Quality Index (DLQI) Pre and Post-treatment. | The DLQI is a questionnaire with 10 questions. The maximum score is 30 and minimum is 0. The higher the score, the more quality of life is impaired. | Posted | Mean | 95% Confidence Interval | score on a scale | Time Frame: 5 weeks |
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| 0 |
| 11 |
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| 11 |
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