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Enhanced Safety Aesthetic Laser System

Primary Purpose

Hirsutism, Hypertrichosis, Telangiectases

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Peterio
Sponsored by
Scilex Ltd.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hirsutism

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age between 18 and 75 years old
  • Fitzpatrick skin types I to VI
  • Unwanted hair or/and
  • Aesthetically disturbing vascular lesions or/and
  • Facial rhytides

Exclusion Criteria:

  • Age below 18 or above 75 year old.
  • Use of photosensitive medications
  • Photosensitive diseases
  • Active infection of any type and active infection or or a history of Herpes Simplex in the treated site
  • Exposure to sun or artificial tanning during the last 3-4 weeks
  • For treatment of facial rhytides- surgical or nonsurgical facial procedure (i.e., laser skin resurfacing, dermabrasion, phenol peel, nonablative laser, or temporary/permanent filler (e.g., collagen, fat, hyaluronic acid injections)

Sites / Locations

  • Hadassah Medical Center, Dermatology

Outcomes

Primary Outcome Measures

Hair, vascular lesions and wrinkles reduction as counted 1-3 months after each treatment session, depending on the treated area.

Secondary Outcome Measures

Measuring treatment discomfort as graded by the patients

Full Information

First Posted
July 1, 2007
Last Updated
July 1, 2007
Sponsor
Scilex Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00495443
Brief Title
Enhanced Safety Aesthetic Laser System
Official Title
Peterio™ - an Add-on Device for Enhanced Safety of Aesthetic Laser Treatments
Study Type
Interventional

2. Study Status

Record Verification Date
July 2007
Overall Recruitment Status
Unknown status
Study Start Date
September 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Scilex Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hirsutism, Hypertrichosis, Telangiectases, Rhytides

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Non-Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Peterio
Primary Outcome Measure Information:
Title
Hair, vascular lesions and wrinkles reduction as counted 1-3 months after each treatment session, depending on the treated area.
Secondary Outcome Measure Information:
Title
Measuring treatment discomfort as graded by the patients

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 18 and 75 years old Fitzpatrick skin types I to VI Unwanted hair or/and Aesthetically disturbing vascular lesions or/and Facial rhytides Exclusion Criteria: Age below 18 or above 75 year old. Use of photosensitive medications Photosensitive diseases Active infection of any type and active infection or or a history of Herpes Simplex in the treated site Exposure to sun or artificial tanning during the last 3-4 weeks For treatment of facial rhytides- surgical or nonsurgical facial procedure (i.e., laser skin resurfacing, dermabrasion, phenol peel, nonablative laser, or temporary/permanent filler (e.g., collagen, fat, hyaluronic acid injections)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alex Rapoport, BSC
Phone
972-39506949
Email
alecr@netvision.net.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leon Gilad, MD
Organizational Affiliation
Hadassah Medical Center, Dermatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah Medical Center, Dermatology
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leon Gilad, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
6836297
Citation
Anderson RR, Parrish JA. Selective photothermolysis: precise microsurgery by selective absorption of pulsed radiation. Science. 1983 Apr 29;220(4596):524-7. doi: 10.1126/science.6836297.
Results Reference
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Enhanced Safety Aesthetic Laser System

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