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Withdrawn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
About this trial
This is an interventional treatment trial for Acne Vulgaris focused on measuring Acne, RadioFrequency
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
Sites / Locations
- Lase Ohr clinic
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
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Withdrawn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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