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

NCT01994616 | Completed

• 1 other identifier: 12/292
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Keloid; Cicatrix, Hypertrophic

Keywords

Keloid, hypertrophic scar

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 (3)

• Scar volume

  0-12months

• Redness (erythema) and pigmentation (melanin),

  0-12months

• Subjective scar evaluation

  0-12months

Study Arms (1)

keloid or hypertrophic scars

All patient including all skin types with keloid or hypertrophic disease receiving Intralesional Cryotherapy

Procedure: Intralesional cryotherapy

Interventions

Intralesional cryotherapy PROCEDURE

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

Also known as: Cryoneedle (CryoShape, Etgar Group International Ltd, Kfar Saba, Israel)

keloid or hypertrophic scars

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A mixed patient population with all Fitzpatrick skin types

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

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead
• Red Cross Hospital Beverwijk: collaborator

Study Sites (1)

VUmc

Amsterdam, North Holland, 1081HV, Netherlands

Location

Related Publications (2)

• Har-Shai Y, Amar M, Sabo E. Intralesional cryotherapy for enhancing the involution of hypertrophic scars and keloids. Plast Reconstr Surg. 2003 May;111(6):1841-52. doi: 10.1097/01.PRS.0000056868.42679.05.

  PMID: 12711943 BACKGROUND

• van Leeuwen MCE, van der Wal MBA, Bulstra AJ, Galindo-Garre F, Molier J, van Zuijlen PPM, van Leeuwen PAM, Niessen FB. Intralesional cryotherapy for treatment of keloid scars: a prospective study. Plast Reconstr Surg. 2015 Feb;135(2):580-589. doi: 10.1097/PRS.0000000000000911.

  PMID: 25626801 DERIVED

Related Links

• homepage VU medical center, hospital Amsterdam, the Netherlands

MeSH Terms

Conditions

Keloid; Cicatrix, Hypertrophic

Condition Hierarchy (Ancestors)

Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michiel CE van Leeuwen, MD

  VUmc

  PRINCIPAL INVESTIGATOR

• Frank B Niessen, PhD, MD

  Vumc

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: November 19, 2013
• First Posted: November 26, 2013
• Study Start: January 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: June 1, 2011
• Last Updated: November 26, 2013

Record last verified: 2013-11

Locations

NL (1)