NCT00495443

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2007

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 3, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2007

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

July 3, 2007

Status Verified

July 1, 2007

First QC Date

July 1, 2007

Last Update Submit

July 1, 2007

Conditions

HirsutismHypertrichosisTelangiectasesRhytides

Outcome Measures

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

Interventions

PeterioDEVICE

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Center, Dermatology

Jerusalem, 91120, Israel

Location

Related Publications (1)

  • 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.

    PMID: 6836297BACKGROUND

MeSH Terms

Conditions

HirsutismHypertrichosisTelangiectasis

Condition Hierarchy (Ancestors)

Hair DiseasesSkin DiseasesSkin and Connective Tissue DiseasesVirilismSigns and SymptomsPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular Diseases

Study Officials

  • Leon Gilad, MD

    Hadassah Medical Center, Dermatology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alex Rapoport, BSC

CONTACT

972-39506949alecr@netvision.net.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 1, 2007

First Posted

July 3, 2007

Study Start

September 1, 2007

Study Completion

September 1, 2008

Last Updated

July 3, 2007

Record last verified: 2007-07

Locations

IL(1)