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Intralesional Cryotherapy for Treatment of Keloid Scars

A Prospective Study

van Leeuwen, Michiel C. E. M.D.; van der Wal, Martijn B. A. M.D., Ph.D.; Bulstra, Anne-Eva J. B.Sc.; Galindo-Garre, Francisca M.Sc.; Molier, Jonneke L.P.N.; van Zuijlen, Paul P. M. Ph.D., M.D.; van Leeuwen, Paul A. M. Ph.D., M.D.; Niessen, Frank B. Ph.D., M.D.

Plastic and Reconstructive Surgery: February 2015 - Volume 135 - Issue 2 - p 580–589
doi: 10.1097/PRS.0000000000000911
Reconstructive: Head and Neck: Original Articles

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.


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.

Received for publication April 18, 2014; accepted July 10, 2014.

This trial is registered under the name “Prospective Evaluation of the Use of Intralesional Cryotherapy for Treatment of Keloid and Hypertrophic Scars,” Clinical identification number NCT01994616 (

Disclosure: The authors have no financial interest to declare in relation to the content of this article. No external funding was received.

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Michiel C. E. van Leeuwen, M.D., Department of Plastic, Reconstructive and Hand Surgery, VU University Medical Center, Postbus 7057, Van der Boechorststraat 7, 1081 BT Amsterdam, The Netherlands,

©2015American Society of Plastic Surgeons