VUmc
Amsterdam, North Holland, 1081HV, Netherlands
NCT Number: NCT01994616
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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Notify Me10 year and older
All sexes
Observational
Amsterdam, North Holland, 1081HV, Netherlands
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
Time frame: 0-12 months
Judgment of recurrence, defined as a growing, pruritic, nodular scar
Time frame: 0-12months
Scar elasticity, measured in two parameters: extension and elasticity
Time frame: 0-12months
Determined by creating a mold of the scar with dental putty
Time frame: 0-12months
Redness (erythema) and pigmentation (melanin), which were measured using the DermaSpectrometer
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'
Amsterdam UMC, location VUmc
Other
Intralesional Cryotherapy for Treatment of Keloid Scars: a Prospective Evaluation
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