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

NCT ID: NCT01994616

Last Updated: 2013-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Keloid Cicatrix, Hypertrophic

Keywords

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Keloid, hypertrophic scar

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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keloid or hypertrophic scars

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

Intralesional cryotherapy

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Other Intervention Names

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Cryoneedle (CryoShape, Etgar Group International Ltd, Kfar Saba, Israel)

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Red Cross Hospital Beverwijk

OTHER

Sponsor Role collaborator

Amsterdam UMC, location VUmc

OTHER

Sponsor Role lead

Responsible Party

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Michiel van Leeuwen

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michiel CE van Leeuwen, MD

Role: PRINCIPAL_INVESTIGATOR

VUmc

Frank B Niessen, PhD, MD

Role: STUDY_DIRECTOR

Vumc

Locations

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VUmc

Amsterdam, North Holland, Netherlands

Site Status

Countries

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Netherlands

References

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Har-Shai Y, Amar M, Sabo E. Intralesional cryotherapy for enhancing the involution of hypertrophic scars and keloids. Plast Reconstr Surg. 2003 May;111(6):1841-52. doi: 10.1097/01.PRS.0000056868.42679.05.

Reference Type BACKGROUND
PMID: 12711943 (View on PubMed)

van Leeuwen MCE, van der Wal MBA, Bulstra AJ, Galindo-Garre F, Molier J, van Zuijlen PPM, van Leeuwen PAM, Niessen FB. Intralesional cryotherapy for treatment of keloid scars: a prospective study. Plast Reconstr Surg. 2015 Feb;135(2):580-589. doi: 10.1097/PRS.0000000000000911.

Reference Type DERIVED
PMID: 25626801 (View on PubMed)

Related Links

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http://www.vumc.nl

homepage VU medical center, hospital Amsterdam, the Netherlands

Other Identifiers

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12/292

Identifier Type: -

Identifier Source: org_study_id