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Enhanced Safety Aesthetic Laser System

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2007 by Scilex Ltd..
Recruitment status was:  Not yet recruiting
Information provided by:
Scilex Ltd. Identifier:
First received: July 1, 2007
Last updated: NA
Last verified: July 2007
History: No changes posted
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.

Condition Intervention
Device: Peterio

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Peterio™ – an Add-on Device for Enhanced Safety of Aesthetic Laser Treatments

Further study details as provided by Scilex Ltd.:

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

Estimated Enrollment: 25
Study Start Date: September 2007
Estimated Study Completion Date: September 2008
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.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00495443

Contact: Alex Rapoport, BSC 972-39506949

Hadassah Medical Center, Dermatology Not yet recruiting
Jerusalem, Israel, 91120
Principal Investigator: Leon Gilad, MD         
Sponsors and Collaborators
Scilex Ltd.
Principal Investigator: Leon Gilad, MD Hadassah Medical Center, Dermatology
  More Information

Publications: Identifier: NCT00495443     History of Changes
Other Study ID Numbers: Peterio-06
Study First Received: July 1, 2007
Last Updated: July 1, 2007

Additional relevant MeSH terms:
Hair Diseases
Skin Diseases
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms processed this record on April 21, 2017