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Enhanced Safety Laser Hair Removal 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 February 2007 by Scilex Ltd..
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00441948
First Posted: March 1, 2007
Last Update Posted: March 1, 2007
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.
Information provided by:
Scilex Ltd.
  Purpose
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 Intervention
Hirsutism Hypertrichosis Device: Peterio

Study Type: Interventional
Study Design: 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.

Further study details as provided by Scilex Ltd.:

Primary Outcome Measures:
  • Hair reduction as counted 1-3 months after each treatment session, depending on the treated area.
  • 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:
  • Measuring treatment discomfort as graded by the patients.

Estimated Enrollment: 10
Study Start Date: May 2007
Estimated Study Completion Date: April 2008
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.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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


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

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

Publications:
ClinicalTrials.gov Identifier: NCT00441948     History of Changes
Other Study ID Numbers: Peterio-05
First Submitted: February 27, 2007
First Posted: March 1, 2007
Last Update Posted: March 1, 2007
Last Verified: February 2007

Keywords provided by Scilex Ltd.:
Hirsutism
Hypertrichosis

Additional relevant MeSH terms:
Hirsutism
Hypertrichosis
Hair Diseases
Skin Diseases
Virilism
Signs and Symptoms