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Status unknownNCT00495443Updated Jul 3, 2007

Enhanced Safety Aesthetic Laser System

An interventional study of Peterio in Hirsutism, Hypertrichosis and Telangiectases, sponsored by Scilex Ltd.. Status unknown at 1 site in Israel. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2007-07-03.

Sponsored by Scilex Ltd. · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2007), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The purpose of this study is to determine whether a new laser system provides better safety and efficacy than existing lasers in popular cosmetic procedures such as hair removal, treatment of cosmetically disturbing vascular lesions and rhytides.

Read the detailed description

Cosmetic lasers are a well-established, popular modality for removal of unwanted hair, treatment of all types of vascular lesions, including hemangiomas, port wine stains, and a variety of telangiectases as well as facial rhytides reduction. The existing lasers are based on a wavelength that is specifically absorbed by the chromophore found in the target such as hair follicle, where the energy is converted to heat resulting in a thermal injury. However, the lasers for cosmetic treatments 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. Similar problem exists when targeting other chromophores such as hemoglobin or water. The purpose of the study is an evaluation of safety and efficacy of a new laser based device.

02

Conditions studied

  • Hirsutism
  • Hypertrichosis
  • Telangiectases
  • Rhytides
03

In context

Hirsutism

41 studies on the registry are indexed under Hirsutism; 8 are open to participants now.

This study's planned enrollment of 25 is below the median of 43 across 26 interventional studies indexed under Hirsutism.

Browse Hirsutism studies →

Lead sponsor

Scilex Ltd. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age between 18 and 75 years old
  • Fitzpatrick skin types I to VI
  • Unwanted hair or/and
  • Aesthetically disturbing vascular lesions or/and
  • Facial rhytides

Exclusion criteria

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
  • For treatment of facial rhytides- surgical or nonsurgical facial procedure (i.e., laser skin resurfacing, dermabrasion, phenol peel, nonablative laser, or temporary/permanent filler (e.g., collagen, fat, hyaluronic acid injections)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single
Enrollment
25 participants (estimated)

Interventions

  • DevicePeterio
06

What researchers measure

Primary outcomes

  1. Hair, vascular lesions and wrinkles reduction as counted 1-3 months after each treatment session, depending on the treated area.

Secondary outcomes

  1. Measuring treatment discomfort as graded by the patients

07

Study locations

1 site
  • Hadassah Medical Center, Dermatology
    Jerusalem, 91120, Israel
    • Leon Gilad, MD · Principal investigator
08

References and documents

Publications

  • Anderson RR, Parrish JA. Selective photothermolysis: precise microsurgery by selective absorption of pulsed radiation. Science. 1983 Apr 29;220(4596):524-7. doi: 10.1126/science.6836297. PubMed 6836297 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 3, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00495443
Lead sponsor
Scilex Ltd.
First posted
Jul 3, 2007
Start date
Sep 2007
Completion
Sep 2008 (estimated)
Last update
Jul 3, 2007

Study contacts

Alex Rapoport, BSC
Contact
alecr@netvision.net.il
972-39506949
Leon Gilad, MD
principal investigator · Hadassah Medical Center, Dermatology

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2007. You cannot join it, but the record below documents what was studied.

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