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

Overview

This prospective evaluation studies the effectiveness of IL cryotherapy in treating keloids and hypertrophic scars in a large population of mixed Fitzpatrick skin types.

Full Title of Study: “Intralesional Cryotherapy for Treatment of Keloid Scars: a Prospective Evaluation”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: January 2011

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.

Interventions

  • 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

Arms, Groups and Cohorts

  • keloid or hypertrophic scars
    • All patient including all skin types with keloid or hypertrophic disease receiving Intralesional Cryotherapy

Clinical Trial Outcome Measures

Primary Measures

  • Recurrence
    • Time Frame: 0-12 months
    • Judgment of recurrence, defined as a growing, pruritic, nodular scar

Secondary Measures

  • Scar elasticity
    • Time Frame: 0-12months
    • Scar elasticity, measured in two parameters: extension and elasticity

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 10 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Amsterdam UMC, location VUmc
  • Collaborator
    • Red Cross Hospital Beverwijk
  • Provider of Information About this Clinical Study
    • Principal Investigator: Michiel van Leeuwen, Medical Doctor – Amsterdam UMC, location VUmc
  • Overall Official(s)
    • Michiel CE van Leeuwen, MD, Principal Investigator, VUmc
    • Frank B Niessen, PhD, MD, Study Director, Vumc

References

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. doi: 10.1097/01.PRS.0000056868.42679.05.

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