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Intralesional Cryotherapy With a Argon Gas Based Device for the Treatment of Keloid and Hypertrophic Scars

Primary Purpose

Keloid, Cicatrix, Hypertrophic

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Intralesional cryotherapy
Sponsored by
Amsterdam UMC, location VUmc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keloid focused on measuring Keloid, hypertrophic scar

Eligibility Criteria

10 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Keloids, defined as excessive scar tissue raised above skin level and proliferating beyond the confines of the original lesion
  • Hypertrophic scars1 older than 12 months and insensitive to other treatments. Keloids were distinguished from hypertrophic scars based on the clinical judgment of experienced plastic surgeons and on the age of the scar (>1yr)
  • A period between previous treatment and IL cryotherapy covered a minimum of 12 weeks
  • Patients with all Fitzpatrick17 skin types
  • Patients older than 10 years of age

Exclusion Criteria:

  • pregnancy
  • diabetes mellitus

Sites / Locations

  • VUmc

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

keloid or hypertrophic scars

Arm Description

All patient including all skin types with keloid or hypertrophic disease receiving Intralesional Cryotherapy

Outcomes

Primary Outcome Measures

Recurrence
Judgment of recurrence, defined as a growing, pruritic, nodular scar

Secondary Outcome Measures

Scar elasticity
Scar elasticity, measured in two parameters: extension and elasticity

Full Information

First Posted
February 10, 2014
Last Updated
February 13, 2014
Sponsor
Amsterdam UMC, location VUmc
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1. Study Identification

Unique Protocol Identification Number
NCT02063243
Brief Title
Intralesional Cryotherapy With a Argon Gas Based Device for the Treatment of Keloid and Hypertrophic Scars
Official Title
Intralesional Cryotherapy With a Argon Gas Based Device for the Treatment of Keloid and Hypertrophic Scars
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Amsterdam UMC, location VUmc

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This prospective evaluation studies the effectiveness of Intralesional (IL) cryotherapy with a argon gas based device in treating keloids and hypertrophic scars in population consisting of all Fitzpatrick skin type patients
Detailed Description
Intralesional (IL) cryotherapy is a novel treatment for keloids and hypertrophic scars, in which the scar is frozen from inside. Published results are promising, however only Caucasian patient populations have been studied. This prospective evaluation studies the effectiveness of IL cryotherapy in treating keloids and hypertrophic scars in a population consisting of all Fitzpatrick skin type patients. Multiple devices are available, mostly based on a simple open system. Closed, argon gas based, systems are highly controlled and provide accurate freezing. However, this technique has never been used for IL cryotherapy for the treatment of keloid or hypertrophic scars. All patients with keloid or hypertrophic scars meeting inclusion criteria were treated with a argon based device called Seednet. Scar quality and possible recurrence are assessed pre- and postsurgery (3, 6 and 12 months) with objective devices determine scar color, scar elasticity, scar volume and patient's skin type. In addition, scars are evaluated using the Patient and Observer Scar Assessment Scale.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keloid, Cicatrix, Hypertrophic
Keywords
Keloid, hypertrophic scar

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
keloid or hypertrophic scars
Arm Type
Other
Arm Description
All patient including all skin types with keloid or hypertrophic disease receiving Intralesional Cryotherapy
Intervention Type
Procedure
Intervention Name(s)
Intralesional cryotherapy
Other Intervention Name(s)
Seednet
Intervention Description
Intralesional (IL) cryotherapy is a treatment for keloids and hypertrophic scars, in which the scar is frozen from inside with the use of a cryoneedle
Primary Outcome Measure Information:
Title
Recurrence
Description
Judgment of recurrence, defined as a growing, pruritic, nodular scar
Time Frame
0-12 months
Secondary Outcome Measure Information:
Title
Scar elasticity
Description
Scar elasticity, measured in two parameters: extension and elasticity
Time Frame
0-12months
Other Pre-specified Outcome Measures:
Title
Scar volume
Description
Determined by creating a mold of the scar with dental putty
Time Frame
0-12months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Keloids, defined as excessive scar tissue raised above skin level and proliferating beyond the confines of the original lesion Hypertrophic scars1 older than 12 months and insensitive to other treatments. Keloids were distinguished from hypertrophic scars based on the clinical judgment of experienced plastic surgeons and on the age of the scar (>1yr) A period between previous treatment and IL cryotherapy covered a minimum of 12 weeks Patients with all Fitzpatrick17 skin types Patients older than 10 years of age Exclusion Criteria: pregnancy diabetes mellitus
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michiel CE van Leeuwen, MD
Organizational Affiliation
VUmc
Official's Role
Principal Investigator
Facility Information:
Facility Name
VUmc
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1081HV
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
25257046
Citation
van Leeuwen MC, Bulstra AE, van Leeuwen PA, Niessen FB. A new argon gas-based device for the treatment of keloid scars with the use of intralesional cryotherapy. J Plast Reconstr Aesthet Surg. 2014 Dec;67(12):1703-10. doi: 10.1016/j.bjps.2014.08.046. Epub 2014 Aug 27.
Results Reference
derived
Links:
URL
http://www.vumc.nl
Description
Link Text: homepage VU medical center, hospital Amsterdam, the Netherlands

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Intralesional Cryotherapy With a Argon Gas Based Device for the Treatment of Keloid and Hypertrophic Scars

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