Clinical trial NCT01994616: Prospective Evaluation of the Use of Intralesional Cryotherapy for Treatment of Keloid and Hypertrophic Scars
Official title: Intralesional Cryotherapy for Treatment of Keloid Scars: a Prospective Evaluation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Keloid
Cicatrix, Hypertrophic
Keywords: Keloid, hypertrophic scar
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
Collaborators: name: Red Cross Hospital Beverwijk
First posted: 2013-11-26
Enrollment: 30
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A mixed patient population with all Fitzpatrick skin types

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.

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

Primary outcomes:
measure: Recurrence
timeFrame: 0-12 months
Secondary outcomes:
measure: Scar elasticity
timeFrame: 0-12months
Other outcomes:
measure: Scar volume
timeFrame: 0-12months
measure: Redness (erythema) and pigmentation (melanin),
timeFrame: 0-12months
measure: Subjective scar evaluation
timeFrame: 0-12months
Locations:
city: Amsterdam
country: Netherlands
facility: VUmc
state: Noord-Holland
Study officials:
affiliation: VUmc
name: Michiel CE van Leeuwen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vumc
name: Frank B Niessen, PhD, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.