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

Keloid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02063243
• Other study ID #: 12/293
• Status: Completed
• Phase: N/A
• First received: February 10, 2014
• Last updated: February 13, 2014
• Start date: January 2010
• Est. completion date: January 2012

Study information

• Verified date: February 2014
• Source: VU University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cicatrix
• Cicatrix, Hypertrophic
• Hypertrophic
• Hypertrophy
• Keloid

Intervention

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

Locations

Country	Name	City	State
Netherlands	VUmc	Amsterdam	Noord-Holland

Sponsors (1)

Lead Sponsor	Collaborator
VU University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Scar volume	Determined by creating a mold of the scar with dental putty	0-12months	No
Primary	Recurrence	Judgment of recurrence, defined as a growing, pruritic, nodular scar	0-12 months	No
Secondary	Scar elasticity	Scar elasticity, measured in two parameters: extension and elasticity	0-12months	No

External Links

•   homepage VU medical center, hospital Amsterdam, the Netherlands