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

Completed

• Conditions: Cicatrix, Hypertrophic; Keloid
• Interventions: Procedure: Intralesional cryotherapy

• Registration Number: NCT01994616
• Lead Sponsor: Amsterdam UMC, location VUmc

Brief Summary

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

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 Timeline

• Study Start: 2009-01
• Primary Completion: 2011-01
• Study Completion: 2011-06
• Status Verified: 2013-11
• Study First Submitted: 2013-11-19
• Study First Submitted QC: 2013-11-19
• Last Update Submitted: 2013-11-19
• Study First Posted: 2013-11-26
• Last Update Posted: 2013-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
keloid or hypertrophic scars	Intralesional cryotherapy	All patient including all skin types with keloid or hypertrophic disease receiving Intralesional Cryotherapy

Primary Outcome Measures

Name	Time	Method
Recurrence	0-12 months	Judgment of recurrence, defined as a growing, pruritic, nodular scar

Secondary Outcome Measures

Name	Time	Method
Scar elasticity	0-12months	Scar elasticity, measured in two parameters: extension and elasticity

Trial Locations

Locations (1)

VUmc; 🇳🇱 Amsterdam, Noord-Holland, Netherlands