Enhanced Safety Laser Hair Removal System

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2007 by Scilex Ltd..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Scilex Ltd.
ClinicalTrials.gov Identifier:
NCT00441948
First received: February 27, 2007
Last updated: NA
Last verified: February 2007
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
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 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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: 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
Study First Received: February 27, 2007
Last Updated: February 27, 2007
Health Authority: Israel: Ministry of Health

Keywords provided by Scilex Ltd.:
Hirsutism
Hypertrichosis

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

ClinicalTrials.gov processed this record on July 23, 2014