Intralesional Cryotherapy With a Argon Gas Based Device for the Treatment of Keloid and Hypertrophic Scars
1 other identifier
interventional
33
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2010
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 10, 2014
CompletedFirst Posted
Study publicly available on registry
February 14, 2014
CompletedFebruary 14, 2014
February 1, 2014
2 years
February 10, 2014
February 13, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Recurrence
Judgment of recurrence, defined as a growing, pruritic, nodular scar
0-12 months
Secondary Outcomes (1)
Scar elasticity
0-12months
Other Outcomes (1)
Scar volume
0-12months
Study Arms (1)
keloid or hypertrophic scars
OTHERAll patient including all skin types with keloid or hypertrophic disease receiving Intralesional Cryotherapy
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- pregnancy
- diabetes mellitus
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VUmc
Amsterdam, North Holland, 1081HV, Netherlands
Related Publications (1)
van Leeuwen MC, Bulstra AE, van Leeuwen PA, Niessen FB. A new argon gas-based device for the treatment of keloid scars with the use of intralesional cryotherapy. J Plast Reconstr Aesthet Surg. 2014 Dec;67(12):1703-10. doi: 10.1016/j.bjps.2014.08.046. Epub 2014 Aug 27.
PMID: 25257046DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michiel CE van Leeuwen, MD
VUmc
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
February 10, 2014
First Posted
February 14, 2014
Study Start
January 1, 2010
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
February 14, 2014
Record last verified: 2014-02