NCT00441948

Brief 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.

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
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 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

February 27, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 1, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2007

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

March 1, 2007

Status Verified

February 1, 2007

First QC Date

February 27, 2007

Last Update Submit

February 27, 2007

Conditions

HirsutismHypertrichosis

Keywords

HirsutismHypertrichosis

Outcome Measures

Primary Outcomes (2)

  • 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.

Secondary Outcomes (1)

  • Measuring treatment discomfort as graded by the patients.

Interventions

PeterioDEVICE

Eligibility Criteria

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

You may qualify if:

  • Age between 18 and 75 years old
  • Fitzpatrick skin types I to VI

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

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

HirsutismHypertrichosis

Condition Hierarchy (Ancestors)

Hair DiseasesSkin DiseasesSkin and Connective Tissue DiseasesVirilismSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Leon Gilad, MD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Leon Gilad, MD

CONTACT

972-26235262leong@cc.huji.ac.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

February 27, 2007

First Posted

March 1, 2007

Study Start

May 1, 2007

Study Completion

April 1, 2008

Last Updated

March 1, 2007

Record last verified: 2007-02

Locations

IL(1)