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

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

Study Description
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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
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

Groups and Cohorts
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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
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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
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01994616


Locations
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Netherlands
VUmc
Amsterdam, Noord-Holland, Netherlands, 1081HV
Sponsors and Collaborators
VU University Medical Center
Red Cross Hospital Beverwijk
Investigators
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Principal Investigator: Michiel CE van Leeuwen, MD VUmc
Study Director: Frank B Niessen, PhD, MD Vumc
More Information
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Additional Information:

Publications:

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

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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    Key Record Dates
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:
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Keloid
Hypertrophy
Cicatrix, Hypertrophic
Cicatrix
Pathological Conditions, Anatomical
 Collagen Diseases
Connective Tissue Diseases
Fibrosis
Pathologic Processes