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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02063243
Other study ID # 12/293
Secondary ID
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


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
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