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

• ClinicalTrials.gov Identifier: NCT01994616
• Recruitment Status: Completed
• First Posted: November 26, 2013
• Last Update Posted: November 26, 2013
• Sponsor: VU University Medical Center
• Collaborator: Red Cross Hospital Beverwijk
• Information provided by (Responsible Party): Michiel van Leeuwen, VU University Medical Center

Study Description

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.

Condition or disease	Intervention/treatment
Keloid; Cicatrix, Hypertrophic	Procedure: Intralesional cryotherapy

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 Design

• Study Type: Observational
• Actual Enrollment: 30 participants
• Time Perspective: Prospective
• Official Title: Intralesional Cryotherapy for Treatment of Keloid Scars: a Prospective Evaluation
• Study Start Date: January 2009
• Actual Primary Completion Date: January 2011
• Actual Study Completion Date: June 2011

Groups and Cohorts

Group/Cohort	Intervention/treatment
keloid or hypertrophic scars; All patient including all skin types with keloid or hypertrophic disease receiving Intralesional Cryotherapy	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; Other Name: Cryoneedle (CryoShape, Etgar Group International Ltd, Kfar Saba, Israel)

Outcome Measures

Primary Outcome Measures :

1. Recurrence [ Time Frame: 0-12 months ]
   Judgment of recurrence, defined as a growing, pruritic, nodular scar

Secondary Outcome Measures :

1. Scar elasticity [ Time Frame: 0-12months ]
   Scar elasticity, measured in two parameters: extension and elasticity

Other Outcome Measures:

1. Scar volume [ Time Frame: 0-12months ]
   Determined by creating a mold of the scar with dental putty
2. Redness (erythema) and pigmentation (melanin), [ Time Frame: 0-12months ]
   Redness (erythema) and pigmentation (melanin), which were measured using the DermaSpectrometer
3. Subjective scar evaluation [ Time Frame: 0-12months ]
   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'

Eligibility Criteria

• Ages Eligible for Study: 10 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

A mixed patient population with all Fitzpatrick skin types

Criteria

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

Contacts and Locations

Locations

Netherlands

VUmc

Amsterdam, Noord-Holland, Netherlands, 1081HV

Sponsors and Collaborators

VU University Medical Center

Red Cross Hospital Beverwijk

Investigators

• Principal Investigator: Michiel CE van Leeuwen, MD; VUmc
• Study Director: Frank B Niessen, PhD, MD; Vumc

More Information

Additional Information:

homepage VU medical center, hospital Amsterdam, the Netherlands 

Publications:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Michiel van Leeuwen, Medical Doctor, VU University Medical Center
• ClinicalTrials.gov Identifier: NCT01994616
• Other Study ID Numbers: 12/292
• First Posted: November 26, 2013
• Last Update Posted: November 26, 2013
• Last Verified: November 2013

Keywords provided by Michiel van Leeuwen, VU University Medical Center:

Keloid, hypertrophic scar

Additional relevant MeSH terms:

Keloid; Hypertrophy; Cicatrix, Hypertrophic; Cicatrix; Pathological Conditions, Anatomical; Collagen Diseases; Connective Tissue Diseases; Fibrosis; Pathologic Processes