Enhanced Safety Laser Hair Removal System

Hirsutism Clinical Trial

Official title:

Peterio™ – an Add-on Device for Enhanced Safety of Aesthetic Laser Treatments.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00441948
• Other study ID #: Peterio-05
• Status: Not yet recruiting
• Phase: N/A
• First received: February 27, 2007
• Last updated: February 27, 2007
• Start date: May 2007
• Est. completion date: April 2008

Study information

• Verified date: February 2007
• Source: Scilex Ltd.
• Contact: Leon Gilad, MD
• Phone: 972-26235262
• Email: leong[@]cc.huji.ac.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: April 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hirsutism
• Hypertrichosis

Intervention

Device:
• Peterio

Locations

Country	Name	City	State
Israel	Hadassah Medical Center, Dermatology	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Scilex Ltd.

Country where clinical trial is conducted

Israel, 

References & Publications (1)

Anderson RR, Parrish JA. Selective photothermolysis: precise microsurgery by selective absorption of pulsed radiation. Science. 1983 Apr 29;220(4596):524-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hair reduction as counted 1-3 months after each treatment session, depending on the treated area.
Primary	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	Measuring treatment discomfort as graded by the patients.