Ignite Creation Date:
2024-05-06 @ 2:42 AM
Last Modification Date:
2024-10-26 @ 11:22 AM
Study NCT ID:
NCT02107482
Status:
COMPLETED
Last Update Posted:
2017-03-31
First Post:
2014-04-04
Brief Title:
Use of Localized NB-UVB Levia in the Treatment of Plaque-psoriasis
Sponsor:
Tufts Medical Center
Organization:
Tufts Medical Center
Study Overview
Official Title:
Bilateral Comparator Sham-Light Source Controlled Assessor Blinded Clinical Trial of Localized Narrow Band-Ultraviolet B NB-UVB Levia Treatment for Plaque-type Psoriasis
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to test the effect of a localized narrow band ultraviolet NB-UVB phototherapy compared to visible light that does not produce UVB on the clearance of psoriasis plaques and resolution of itching Localized NB-UVB Levia phototherapy device is cleared by the US Food and Drug Administration FDA
Detailed Description:
This will be an ascending dose study with treatments three times per week initial treatment dose and increasing regimen is adjusted according to the subject skin type A suggested treatment regimen schedule provided from Lerner Medical Devices Inc
For subjects with skin type I starting dose of 195 mjcm2 for subjects with skin type II starting dose of 330 mjcm2 for subjects with skin type III starting dose of 390 mjcm2 for subjects with skin type IV starting dose of 495 mjcm2 for subjects with skin type V starting dose of 525 mjcm2 for subjects with skin type VI starting dose of 600 mjcm2
The dose will be increased by 15 with each treatment as long as there are no side effects with treatment such as burning or redness
For subjects with skin type I starting dose of 195 mjcm2 for subjects with skin type II starting dose of 330 mjcm2 for subjects with skin type III starting dose of 390 mjcm2 for subjects with skin type IV starting dose of 495 mjcm2 for subjects with skin type V starting dose of 525 mjcm2 for subjects with skin type VI starting dose of 600 mjcm2
The dose will be increased by 15 with each treatment as long as there are no side effects with treatment such as burning or redness
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None