Ignite Creation Date:
2024-05-06 @ 1:04 PM
Last Modification Date:
2024-10-26 @ 1:08 PM
Study NCT ID:
NCT03921814
Status:
COMPLETED
Last Update Posted:
2022-10-20
First Post:
2019-04-01
Brief Title:
Sunstone IPL Intense Pulsed Light for Hair Reduction
Sponsor:
Philips Healthcare
Organization:
Philips Healthcare
Study Overview
Official Title:
Clinical Investigation of Safety and Efficacy of a Philips Intense Pulsed Light Device for Hair Reduction Sunstone 2019
Status:
COMPLETED
Status Verified Date:
2022-10
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 is a prospective multi-center single-arm single blinded study to evaluate the safety and efficacy of the Sunstone IPL Intense Pulsed Light device to remove hair
Detailed Description:
Prospective multi-center single-arm single blinded Philips hair counter study in healthy women of skin types I up to and including V
Safety and efficacy of hair removal with the Investigational Philips IPL-device will be investigated
In-clinic each study subject will undergo twelve IPL-treatments at four areas bilaterally face axilla bikini line and legs with an investigational IPL device applied by a device operator
Hair re-growth in four body areas face axillae bikini line and leg will be evaluated separately
After the 4 bi-weekly treatments one follow-up visit will be organized After the completion of full treatment cycle 12 treatments subjects will be followed for 1 and 3 months short-term follow-up and for 6 9 and 12 months long-term follow up
Safety and efficacy of hair removal with the Investigational Philips IPL-device will be investigated
In-clinic each study subject will undergo twelve IPL-treatments at four areas bilaterally face axilla bikini line and legs with an investigational IPL device applied by a device operator
Hair re-growth in four body areas face axillae bikini line and leg will be evaluated separately
After the 4 bi-weekly treatments one follow-up visit will be organized After the completion of full treatment cycle 12 treatments subjects will be followed for 1 and 3 months short-term follow-up and for 6 9 and 12 months long-term follow up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None