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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Intralesional Cryotherapy for Treatment of Keloid Scars: a Prospective Evaluation

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.

Detailed Summary: 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.
Sponsor: VU University Medical Center

Current Primary Outcome: Recurrence [ Time Frame: 0-12 months ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome: Scar elasticity [ Time Frame: 0-12months ]

Scar elasticity, measured in two parameters: extension and elasticity


Original Secondary Outcome: Same as current

Information By: VU University Medical Center

Dates:
Date Received: November 19, 2013
Date Started: January 2009
Date Completion:
Last Updated: November 19, 2013
Last Verified: November 2013