Ignite Creation Date:
2024-05-05 @ 6:30 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00495443
Status:
UNKNOWN
Last Update Posted:
2007-07-03
First Post:
2007-07-01
Brief Title:
Enhanced Safety Aesthetic Laser System
Sponsor:
Scilex Ltd
Organization:
Scilex Ltd
Study Overview
Official Title:
Peterio - an Add-on Device for Enhanced Safety of Aesthetic Laser Treatments
Status:
UNKNOWN
Status Verified Date:
2007-07
Last Known Status:
NOT_YET_RECRUITING
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 this study is to determine whether a new laser system provides better safety and efficacy than existing lasers in popular cosmetic procedures such as hair removal treatment of cosmetically disturbing vascular lesions and rhytides
Detailed Description:
Cosmetic lasers are a well-established popular modality for removal of unwanted hair treatment of all types of vascular lesions including hemangiomas port wine stains and a variety of telangiectases as well as facial rhytides reduction The existing lasers are based on a wavelength that is specifically absorbed by the chromophore found in the target such as hair follicle where the energy is converted to heat resulting in a thermal injury However the lasers for cosmetic treatments are not without limitations A laser based long-term hair removal treatment is based on thermal destruction of the hair shaft and follicle using wavelengths that are specifically absorbed by the pigment melanin found in the hair follicle The heating of hair follicle is done through heat dissipation from the hair shaft One of the significant limitations of this approach is the fact that the epidermis through which the light energy must penetrate is rich in melanin and therefore absorbs a major portion of the energy resulting in inadequate heating of the hair follicles Similar problem exists when targeting other chromophores such as hemoglobin or water The purpose of the study is an evaluation of safety and efficacy of a new laser based device
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