Keloid Clinical Trial
Official title:
Intralesional Cryotherapy With a Argon Gas Based Device for the Treatment of Keloid and Hypertrophic Scars
This prospective evaluation studies the effectiveness of Intralesional (IL) cryotherapy with a argon gas based device in treating keloids and hypertrophic scars in population consisting of all Fitzpatrick skin type patients
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 population
consisting of all Fitzpatrick skin type patients.
Multiple devices are available, mostly based on a simple open system. Closed, argon gas
based, systems are highly controlled and provide accurate freezing. However, this technique
has never been used for IL cryotherapy for the treatment of keloid or hypertrophic scars.
All patients with keloid or hypertrophic scars meeting inclusion criteria were treated with
a argon based device called Seednet. 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.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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