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Status unknownNCT00441948Updated Mar 1, 2007

Enhanced Safety Laser Hair Removal System

An interventional study of Peterio in Hirsutism and Hypertrichosis, sponsored by Scilex Ltd.. Status unknown at 1 site in Israel. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2007-03-01.

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

The sponsor has not verified this record recently (last verified Feb 2007), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
10
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 in hair removal than existing lasers.

Read the 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.

02

Conditions studied

  • Hirsutism
  • Hypertrichosis

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Keywords

  • Hirsutism
  • Hypertrichosis
03

In context

Hirsutism

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

This study's enrollment of 10 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
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single
Enrollment
10 participants

Interventions

  • DevicePeterio
06

What researchers measure

Primary outcomes

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

  2. 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 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

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2007 and a completion of Apr 2008. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 27, 2007
First posted
Mar 1, 2007
Start
May 2007
Completion
Apr 2008
Last update
Mar 1, 2007
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
No changes since tracking began. The registry record was last updated on Mar 1, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00441948
Lead sponsor
Scilex Ltd.
First posted
Mar 1, 2007
Start date
May 2007
Completion
Apr 2008
Last update
Mar 1, 2007

Study contacts

Leon Gilad, MD
Contact
leong@cc.huji.ac.il
972-26235262
Leon Gilad, MD
principal investigator · Hadassah Medical Organization

Oversight

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

Not currently enrolling

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

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Discussion

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