The Treatment of Acne Vulgaris With Radiofrequency Device | NCT00441805

Studies
The Treatment of Acne Vulgaris With Radiofrequency Device

NCT00441805

Sponsor

Alma Lasers

Status

Withdrawn

Last Update Posted

Oct 9, 2020Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Acne Vulgaris

Interventions

Radio Frequency

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Terminated- the study was not started (per Investigator's/sponsor decision)

Expanded Access Info

Start Date

Nov 2006Estimated

Primary Completion Date

Sep 2007Estimated

Completion Date

Sep 2007Estimated

First Submitted Date

Feb 27, 2007

First Submission Date that Met QC Criteria

Feb 28, 2007

First Posted Date

Mar 1, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 8, 2020

Last Update Posted Date

Oct 9, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Name	Type	Description	Arm Group Labels	Other Names
Radio Frequency	Device

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Yussi Levcelter, Dr.	Alma Lasers LTD	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D000152	Acne Vulgaris

Ancestor Terms

ID	Term
D017486	Acneiform Eruptions
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D012625	Sebaceous Gland Diseases

Browse Leaves

Not provided

Browse Branches

Not provided