Enhanced Safety Laser Hair Removal System
Recruitment status was Not yet recruiting
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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. |
- 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.
- Measuring treatment discomfort as graded by the patients.
| Estimated Enrollment: | 10 |
| Study Start Date: | May 2007 |
| Estimated Study Completion Date: | April 2008 |
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 |
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| Contact: Leon Gilad, MD | 972-26235262 | leong@cc.huji.ac.il |
| Israel | |
| Hadassah Medical Center, Dermatology | Not yet recruiting |
| Jerusalem, Israel, 91120 | |
| Principal Investigator: Leon Gilad, MD | |
| 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 June 18, 2013