Enhanced Safety Aesthetic Laser System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00495443
Recruitment Status : Unknown
Verified July 2007 by Scilex Ltd..
Recruitment status was:  Not yet recruiting
First Posted : July 3, 2007
Last Update Posted : July 3, 2007
Information provided by:
Scilex Ltd.

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.

Condition or disease Intervention/treatment Phase
Hirsutism Hypertrichosis Telangiectases Rhytides Device: Peterio Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Peterio™ – an Add-on Device for Enhanced Safety of Aesthetic Laser Treatments
Study Start Date : September 2007
Estimated Study Completion Date : September 2008

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

Secondary Outcome Measures :
  1. Measuring treatment discomfort as graded by the patients

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Publications: Identifier: NCT00495443     History of Changes
Other Study ID Numbers: Peterio-06
First Posted: July 3, 2007    Key Record Dates
Last Update Posted: July 3, 2007
Last Verified: July 2007

Additional relevant MeSH terms:
Hair Diseases
Skin Diseases
Signs and Symptoms
Vascular Diseases
Cardiovascular Diseases