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Intralesional Cryotherapy With a Argon Gas Based Device for the Treatment of Keloid and Hypertrophic Scars

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ClinicalTrials.gov Identifier: NCT02063243
Recruitment Status : Completed
First Posted : February 14, 2014
Last Update Posted : February 14, 2014
Sponsor:
Information provided by (Responsible Party):
Michiel van Leeuwen, VU University Medical Center

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

Condition or disease Intervention/treatment Phase
Keloid Cicatrix Hypertrophic Procedure: Intralesional cryotherapy Not Applicable

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 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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intralesional Cryotherapy With a Argon Gas Based Device for the Treatment of Keloid and Hypertrophic Scars
Study Start Date : January 2010
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

Arm Intervention/treatment
keloid or hypertrophic scars
All patient including all skin types with keloid or hypertrophic disease receiving Intralesional Cryotherapy
Procedure: Intralesional cryotherapy
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
Other Name: Seednet




Primary Outcome Measures :
  1. Recurrence [ Time Frame: 0-12 months ]
    Judgment of recurrence, defined as a growing, pruritic, nodular scar


Secondary Outcome Measures :
  1. Scar elasticity [ Time Frame: 0-12months ]
    Scar elasticity, measured in two parameters: extension and elasticity


Other Outcome Measures:
  1. Scar volume [ Time Frame: 0-12months ]
    Determined by creating a mold of the scar with dental putty



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02063243


Locations
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Netherlands
VUmc
Amsterdam, Noord-Holland, Netherlands, 1081HV
Sponsors and Collaborators
VU University Medical Center
Investigators
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Principal Investigator: Michiel CE van Leeuwen, MD VUmc

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Michiel van Leeuwen, MD, VU University Medical Center
ClinicalTrials.gov Identifier: NCT02063243    
Other Study ID Numbers: 12/293
First Posted: February 14, 2014    Key Record Dates
Last Update Posted: February 14, 2014
Last Verified: February 2014
Keywords provided by Michiel van Leeuwen, VU University Medical Center:
Keloid, hypertrophic scar
Additional relevant MeSH terms:
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Keloid
Hypertrophy
Cicatrix, Hypertrophic
Cicatrix
Pathological Conditions, Anatomical
Collagen Diseases
Connective Tissue Diseases
Fibrosis
Pathologic Processes