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The Treatment of Acne Vulgaris With Radiofrequency Device

Primary Purpose

Acne Vulgaris

Status
Withdrawn
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Radio Frequency
Sponsored by
Alma Lasers
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris focused on measuring Acne, RadioFrequency

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • mild-moderate Acne
  • age over 18
  • otherwise healthy

Exclusion Criteria:

  • age under 18
  • pregnancy
  • systemic acne treatment in the last month
  • local acne treatment in the last month

Sites / Locations

  • Lase Ohr clinic

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 27, 2007
Last Updated
October 8, 2020
Sponsor
Alma Lasers
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1. Study Identification

Unique Protocol Identification Number
NCT00441805
Brief Title
The Treatment of Acne Vulgaris With Radiofrequency Device
Official Title
The Treatment of Acne Vulgaris With Radiofrequency Device
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Terminated- the study was not started (per Investigator's/sponsor decision)
Study Start Date
November 2006 (Anticipated)
Primary Completion Date
September 2007 (Anticipated)
Study Completion Date
September 2007 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alma Lasers

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Radiofrequency emmitting device, normaly used for thermage treatments will be used on 22 mild to moderate acne patients faces. The aim of the study is to check whether RF heating of subcutaneous and dermis will improve acne in needed patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
Acne, RadioFrequency

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Radio Frequency

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: mild-moderate Acne age over 18 otherwise healthy Exclusion Criteria: age under 18 pregnancy systemic acne treatment in the last month local acne treatment in the last month
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yussi Levcelter, Dr.
Organizational Affiliation
Alma Lasers LTD
Official's Role
Study Director
Facility Information:
Facility Name
Lase Ohr clinic
City
Jerusalem
Country
Israel

12. IPD Sharing Statement

Learn more about this trial

The Treatment of Acne Vulgaris With Radiofrequency Device

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