Prospective Evaluation of the Use of Intralesional Cryotherapy for Treatment of Keloid and Hypertrophic Scars

November 19, 2013 updated by: Michiel van Leeuwen, Amsterdam UMC, location VUmc

Intralesional Cryotherapy for Treatment of Keloid Scars: a Prospective Evaluation

This prospective evaluation studies the effectiveness of IL cryotherapy in treating keloids and hypertrophic scars in a large population of mixed Fitzpatrick skin types.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 large population of mixed Fitzpatrick skin types. All patients with keloid or hypertrophic scars meeting inclusion criteria were treated with a liquid nitrogen based device called Cryoshape 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.

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1081HV
        • VUMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

A mixed patient population with all Fitzpatrick skin types

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
keloid or hypertrophic scars
All patient including all skin types with keloid or hypertrophic disease receiving Intralesional Cryotherapy
Procedure: Intralesional cryotherapy
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
Other Names:
  • Cryoneedle (CryoShape, Etgar Group International Ltd, Kfar Saba, Israel)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence
Time Frame: 0-12 months
Judgment of recurrence, defined as a growing, pruritic, nodular scar
0-12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Scar elasticity
Time Frame: 0-12months
Scar elasticity, measured in two parameters: extension and elasticity
0-12months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Scar volume
Time Frame: 0-12months
Determined by creating a mold of the scar with dental putty
0-12months
Redness (erythema) and pigmentation (melanin),
Time Frame: 0-12months
Redness (erythema) and pigmentation (melanin), which were measured using the DermaSpectrometer
0-12months
Subjective scar evaluation
Time Frame: 0-12months
performed by two experienced medical doctors and the patient using the Patient and Observer Scar Assessment Scale (POSAS). Each item of the POSAS was scored using a 10-step score, in which 10 reflected 'worst scar imaginable' and 1 indicated 'normal skin'
0-12months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amsterdam UMC, location VUmc

Collaborators

Red Cross Hospital Beverwijk

Investigators

  • Principal Investigator: Michiel CE van Leeuwen, MD, VUMC
  • Study Director: Frank B Niessen, PhD, MD, VUMC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

November 19, 2013

First Submitted That Met QC Criteria

November 19, 2013

First Posted (Estimate)

November 26, 2013

Study Record Updates

Last Update Posted (Estimate)

November 26, 2013

Last Update Submitted That Met QC Criteria

November 19, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12/292

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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