title: Intralesional cryotherapy for treatment of keloid scars: a prospective study.
abstract: BACKGROUND
  Intralesional cryotherapy is a novel treatment for keloid scars in which the scar is frozen from inside. Published results are promising, but the treatment has only been tested in a Caucasian patient population. Therefore, the authors evaluated intralesional cryotherapy in a patient population including different Fitzpatrick skin types (I through VI).
  
  
  METHODS
  This prospective multicenter study with a 1-year follow-up included 27 patients with 29 keloid scars. Intralesional cryotherapy was administered with a disposable liquid nitrogen-based device called CryoShape. Scar assessment was performed using the Patient and Observer Scar Assessment Scale and four objective devices to determine scar color, scar elasticity, scar volume, and patient skin type.
  
  
  RESULTS
  Keloid scars showed an average volume decrease of 63 percent (range, 16 to 100 percent) after 12 months, compared with baseline (p < 0.01). Recurrence was seen in seven keloids (24 percent) and hypopigmentation recovered in 69 percent of all keloid scars within 12 months. Scar assessment with the Patient and Observer Scar Assessment Scale showed an overall improvement according to both doctors and patients. In addition, complaints of pain and itching were reduced. When analyzing the results per Fitzpatrick skin type, African American patients showed a higher incidence of persistent hypopigmentation (p = 0.02).
  
  
  CONCLUSIONS
  Intralesional cryotherapy for the treatment of keloid scars shows favorable results in terms of reduction of volume and complaints of pain and pruritus. However, no complete eradication was obtained in some cases and recurring scars were seen. In addition, persistent hypopigmentation proved a problem in non-Caucasian patients.
  
  
  METHODS
  Therapeutic, IV.
authors: Amsterdam and Beverwijk, The Netherlands From the Departments of Plastic and Reconstructive Surgery, Biostatistics, and Surgery, and the MOVE Institute, VU University Medical Center; and the Department of Plastic and Reconstructive Surgery and the Burn Center, Red Cross Hospital.
authors: Michiel C E
authors: MCE
authors: van Leeuwen
authors: Martijn B A
authors: MBA
authors: van der Wal
authors: Anne-Eva J
authors: AJ
authors: Bulstra
authors: Francisca
authors: F
authors: Galindo-Garre
authors: Jonneke
authors: J
authors: Molier
authors: Paul P M
authors: PPM
authors: van Zuijlen
authors: Paul A M
authors: PAM
authors: van Leeuwen
authors: Frank B
authors: FB
authors: Niessen
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D044466:Asian People; D044383:Black People; D002648:Child; D003452:Cryosurgery / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods*; D005260:Female; D006801:Humans; D017496:Hypopigmentation / Q000209:etiology; D015552:Injections, Intralesional; D007627:Keloid / Q000150:complications / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009339:Needles; D009426:Netherlands; D009584:Nitrogen / Q000008:administration & dosage / Q000627:therapeutic use; D010146:Pain / Q000209:etiology; D011183:Postoperative Complications / Q000209:etiology; D011446:Prospective Studies; D011537:Pruritus / Q000209:etiology; D012008:Recurrence; D012720:Severity of Illness Index; D012880:Skin Pigmentation; D044465:White People; D055815:Young Adult; D001741:Black or African American
chemical_list: D009584:Nitrogen
references: Niessen FB, Spauwen PH, Schalkwijk J, Kon M. On the nature of hypertrophic scars and keloids: A review. Plast Reconstr Surg. 1999;104:1435–1458
references: Bock O, Schmid-Ott G, Malewski P, Mrowietz U. Quality of life of patients with keloid and hypertrophic scarring. Arch Dermatol Res. 2006;297:433–438
references: Bischof M, Krempien R, Debus J, Treiber M. Postoperative electron beam radiotherapy for keloids: Objective findings and patient satisfaction in self-assessment. Int J Dermatol. 2007;46:971–975
references: Mustoe TA, Cooter RD, Gold MH, et al.International Advisory Panel on Scar Management. International clinical recommendations on scar management. Plast Reconstr Surg. 2002;110:560–571
references: Lawrence WT. In search of the optimal treatment of keloids: Report of a series and a review of the literature. Ann Plast Surg. 1991;27:164–178
references: Zouboulis CC. Principles of cutaneous cryosurgery: An update. Dermatology. 1999;198:111–117
references: Zouboulis CC, Blume U, Büttner P, Orfanos CE. Outcomes of cryosurgery in keloids and hypertrophic scars: A prospective consecutive trial of case series. Arch Dermatol. 1993;129:1146–1151
references: Weshahy AH. Intralesional cryosurgery: A new technique using cryoneedles. J Dermatol Surg Oncol. 1993;19:123–126
references: Gupta S, Kumar B. Intralesional cryosurgery using lumbar puncture and/or hypodermic needles for large, bulky, recalcitrant keloids. Int J Dermatol. 2001;40:349–353
references: Har-Shai Y, Brown W, Labbé D, et al. Intralesional cryosurgery for the treatment of hypertrophic scars and keloids following aesthetic surgery: The results of a prospective observational study. Int J Low Extrem Wounds. 2008;7:169–175
references: Har-Shai Y, Amar M, Sabo E. Intralesional cryotherapy for enhancing the involution of hypertrophic scars and keloids. Plast Reconstr Surg. 2003;111:1841–1852
references: Kenney JA Jr. Pigmentary disorders in black skin. Clin Dermatol. 1989;7:1–10
references: English RS, Shenefelt PD. Keloids and hypertrophic scars. Dermatol Surg. 1999;25:631–638
references: van der Wal MB, Tuinebreijer WE, Bloemen MC, Verhaegen PD, Middelkoop E, van Zuijlen PP. Rasch analysis of the Patient and Observer Scar Assessment Scale (POSAS) in burn scars. Qual Life Res. 2012;21:13–23
references: Nicholas RS, Falvey H, Lemonas P, et al. Patient-related keloid scar assessment and outcome measures. Plast Reconstr Surg. 2012;129:648–656
references: Ogawa R. The most current algorithms for the treatment and prevention of hypertrophic scars and keloids. Plast Reconstr Surg. 2010;125:557–568
references: Fitzpatrick TB. The validity and practicality of sun-reactive skin types I through VI. Arch Dermatol. 1988;124:869–871
references: Cosman B, Wolff M. Bilateral earlobe keloids. Plast Reconstr Surg. 1974;53:540–543
references: Draaijers LJ, Botman YA, Tempelman FR, Kreis RW, Middelkoop E, van Zuijlen PP. Skin elasticity meter or subjective evaluation in scars: A reliability assessment. Burns. 2004;30:109–114
references: van der Wal M, Bloemen M, Verhaegen P, et al. Objective color measurements: Clinimetric performance of three devices on normal skin and scar tissue. J Burn Care Res. 2013;34:e187–e194
references: van de Kar AL, Corion LU, Smeulders MJ, Draaijers LJ, van der Horst CM, van Zuijlen PP. Reliable and feasible evaluation of linear scars by the Patient and Observer Scar Assessment Scale. Plast Reconstr Surg. 2005;116:514–522
references: Zouboulis CC, Rosenberger AD, Forster T, Beller G, Kratzsch M, Felsenberg D. Modification of a device and its application for intralesional cryosurgery of old recalcitrant keloids. Arch Dermatol. 2004;140:1293–1294
references: Weshahy AH, Abdel Hay R. Intralesional cryosurgery and intralesional steroid injection: A good combination therapy for treatment of keloids and hypertrophic scars. Dermatol Ther. 2012;25:273–276
references: Har-Shai Y, Dujovny E, Rohde E, Zouboulis CC. Effect of skin surface temperature on skin pigmentation during contact and intralesional cryosurgery of keloids. J Eur Acad Dermatol Venereol. 2007;21:191–198
references: Har-Shai Y, Sabo E, Rohde E, Hyams M, Assaf C, Zouboulis CC. Intralesional cryosurgery enhances the involution of recalcitrant auricular keloids: A new clinical approach supported by experimental studies. Wound Repair Regen. 2006;14:18–27
references: Arnault JP, Peiffert D, Latarche C, Chassagne JF, Barbaud A, Schmutz JL. Keloids treated with postoperative Iridium 192* brachytherapy: A retrospective study. J Eur Acad Dermatol Venereol. 2009;23:807–813
references: Veen RE, Kal HB. Postoperative high-dose-rate brachytherapy in the prevention of keloids. Int J Radiat Oncol Biol Phys. 2007;69:1205–1208
references: van Leeuwen MC, Stokmans SC, Bulstra AE, Meijer OW, van Leeuwen PA, Niessen FB. High-dose-rate brachytherapy for the treatment of recalcitrant keloids: A unique effective treatment protocol. Plast Reconstr Surg. 2014;134:527–534
references: Bijlard E, Timman R, Verduijn GM, et al. Intralesional cryotherapy versus excision and corticosteroids or brachytherapy for keloid treatment: Study protocol for a randomised controlled trial. Trials. 2013;14:439