Enhanced Safety Aesthetic Laser System

Hirsutism Clinical Trial

Official title:

Peterio™ – an Add-on Device for Enhanced Safety of Aesthetic Laser Treatments

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00495443
• Other study ID #: Peterio-06
• Status: Not yet recruiting
• Phase: N/A
• First received: July 1, 2007
• Last updated: July 1, 2007
• Start date: September 2007
• Est. completion date: September 2008

Study information

• Verified date: July 2007
• Source: Scilex Ltd.
• Contact: Alex Rapoport, BSC
• Phone: 972-39506949
• Email: alecr[@]netvision.net.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hirsutism
• Hypertrichosis
• Rhytides
• Telangiectases
• Telangiectasis

Intervention

Device:
• Peterio

Locations

Country	Name	City	State
Israel	Hadassah Medical Center, Dermatology	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Scilex Ltd.

Country where clinical trial is conducted

Israel, 

References & Publications (1)

Anderson RR, Parrish JA. Selective photothermolysis: precise microsurgery by selective absorption of pulsed radiation. Science. 1983 Apr 29;220(4596):524-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hair, vascular lesions and wrinkles reduction as counted 1-3 months after each treatment session, depending on the treated area.
Secondary	Measuring treatment discomfort as graded by the patients