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Enhanced Safety Laser Hair Removal System

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ClinicalTrials.gov Identifier: NCT00441948
Recruitment Status : Unknown
Verified February 2007 by Scilex Ltd..
Recruitment status was:  Not yet recruiting
First Posted : March 1, 2007
Last Update Posted : March 1, 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 in hair removal than existing lasers.

Condition or disease Intervention/treatment
Hirsutism Hypertrichosis Device: Peterio

Detailed Description:

Lasers are a well-established, popular modality for removal of unwanted hair. The existing lasers are based on a wavelength that is specifically absorbed by the pigment melanin found in the hair follicle, where the energy is converted to heat resulting in a thermal injury.

However, lasers for hair removal 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. The purpose of the study is an evaluation safety and efficacy of a new laser based device.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 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 : May 2007
Estimated Study Completion Date : April 2008

Primary Outcome Measures :
  1. Hair reduction as counted 1-3 months after each treatment session, depending on the treated area.
  2. Long term clearance will be calculated as the ratio between the value of the baseline hair count taken immediately before the first treatment, and the value obtained at the 3-6 month post treatment hair count.

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, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Age between 18 and 75 years old
  • Fitzpatrick skin types I to VI

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

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 ClinicalTrials.gov identifier (NCT number): NCT00441948

Contact: Leon Gilad, MD 972-26235262 leong@cc.huji.ac.il

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 Organization

ClinicalTrials.gov Identifier: NCT00441948     History of Changes
Other Study ID Numbers: Peterio-05
First Posted: March 1, 2007    Key Record Dates
Last Update Posted: March 1, 2007
Last Verified: February 2007

Keywords provided by Scilex Ltd.:

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