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

Study Overview
=================
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 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.

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

Conditions
-----------------
Keloid, Cicatrix, Hypertrophic

Intervention / Treatment
-----------------
* Procedure: Intralesional cryotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 10 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| keloid or hypertrophic scars<br>All patient including all skin types with keloid or hypertrophic disease receiving Intralesional Cryotherapy | Procedure: Intralesional cryotherapy<br>* 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<br>* Other names: Cryoneedle (CryoShape, Etgar Group International Ltd, Kfar Saba, Israel);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence | Judgment of recurrence, defined as a growing, pruritic, nodular scar | 0-12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scar elasticity | Scar elasticity, measured in two parameters: extension and elasticity | 0-12months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Keloid, hypertrophic scar