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Completed

NCT Number: NCT01994616

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

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

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Key information

Age range

10 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

VUmc

Amsterdam, North Holland, 1081HV, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intralesional cryotherapy

Procedure

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 names: Cryoneedle (CryoShape, Etgar Group International Ltd, Kfar Saba, Israel)

Primary outcomes

  1. Recurrence

    Time frame: 0-12 months

    Judgment of recurrence, defined as a growing, pruritic, nodular scar

Secondary outcomes

  1. Scar elasticity

    Time frame: 0-12months

    Scar elasticity, measured in two parameters: extension and elasticity

Other outcomes

  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'

Sponsors and collaborators

Lead sponsor

Amsterdam UMC, location VUmc

Other

Collaborators

  • Red Cross Hospital Beverwijk

Registry information

Official study title

Intralesional Cryotherapy for Treatment of Keloid Scars: a Prospective Evaluation

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Nov 26, 2013
Registry last updated
Nov 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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