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

Keloid Clinical Trial

Official title:

Intralesional Cryotherapy for Treatment of Keloid Scars: a Prospective Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01994616
• Other study ID #: 12/292
• Status: Completed
• Phase: N/A
• First received: November 19, 2013
• Last updated: November 19, 2013
• Start date: January 2009
• Est. completion date: June 2011

Study information

• Verified date: November 2013
• Source: VU University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2011
• Est. primary completion date: January 2011
• 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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Cicatrix, 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 (2)

Lead Sponsor	Collaborator
VU University Medical Center	Red Cross Hospital Beverwijk

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

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. — View Citation

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
Other	Redness (erythema) and pigmentation (melanin),	Redness (erythema) and pigmentation (melanin), which were measured using the DermaSpectrometer	0-12months	No
Other	Subjective scar evaluation	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	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