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
Status | Completed |
Enrollment | 33 |
Est. completion date | January 2012 |
Est. primary completion date | January 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 10 Years and older |
Eligibility |
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Netherlands | VUmc | Amsterdam | Noord-Holland |
Lead Sponsor | Collaborator |
---|---|
VU University Medical Center |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Scar volume | Determined by creating a mold of the scar with dental putty | 0-12months | No |
Primary | Recurrence | Judgment of recurrence, defined as a growing, pruritic, nodular scar | 0-12 months | No |
Secondary | Scar elasticity | Scar elasticity, measured in two parameters: extension and elasticity | 0-12months | No |
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