Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00375544
Status:
COMPLETED
Last Update Posted:
2009-08-14
First Post:
2006-09-11
Brief Title:
Study to Evaluate the Safety and Efficacy of a Low Level Light Device in Patients With Knee Osteoarthritis
Sponsor:
Light Sciences LLC
Organization:
Light Sciences LLC
Study Overview
Official Title:
A Phase I Single Center Open Label Study to Evaluate the Safety and Efficacy of a Low Level Light Device in Patients With Knee Osteoarthritis
Status:
COMPLETED
Status Verified Date:
2009-08
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:
This Phase I study is being conducted to examine the efficacy of the Light Sciences LLC LSLLC phototherapy device for home self treatment of knee osteoarthritis OA
Detailed Description:
This Phase I study is being conducted to examine the efficacy of the Light Sciences LLC LSLLC phototherapy device for home self - treatment of knee osteoarthritis OA Clinical efficacy will be assessed by evaluating the level of reported pain including the use of analgesics various measures of functional improvement and clinical symptomology during a three week period of daily treatments Durability of the clinical response for twelve weeks following therapy will also be examined In addition device safety will be assessed As this is an early stage-prototype device subject input regarding the usability of the device will be sought
Subjects will be required to achieve three weeks of wash-out from all OA therapies prior to the start of phototherapy Acetaminophen will be allowed during this time During the three week active treatment and twelve week follow-up periods subjects will be required to refrain from acetaminophen as well as OA therapies However subjects will be encouraged to speak with the investigator should any symptoms become difficult to manage In addition to clinical assessments subjects will be required to keep a daily diary
The clinical objectives of the study will be met if at least five of ten subjects report decreased pain scores and improvement on an osteoarthritis index While minimum or no safety issues are expected the occurrence of skin changes to the area exposed to the device will be carefully monitored
Subjects will be required to achieve three weeks of wash-out from all OA therapies prior to the start of phototherapy Acetaminophen will be allowed during this time During the three week active treatment and twelve week follow-up periods subjects will be required to refrain from acetaminophen as well as OA therapies However subjects will be encouraged to speak with the investigator should any symptoms become difficult to manage In addition to clinical assessments subjects will be required to keep a daily diary
The clinical objectives of the study will be met if at least five of ten subjects report decreased pain scores and improvement on an osteoarthritis index While minimum or no safety issues are expected the occurrence of skin changes to the area exposed to the device will be carefully monitored
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