Pulsed 1064nm Nd:YAG in the Treatment of Verruca Vulgaris Versus Conventional Therapy With Liquid Nitrogen Cryotherapy

NCT01609530 | Terminated DMC

• 1 other identifier: HSR 11-1215
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

Verruca vulgaris (VV), or the common wart, is a relatively prevalent and often frustrating cutaneous disease to treat. A single, highly effective therapy for the treatment of VV has not been found. Liquid nitrogen is considered the standard of care for VV and studies report a 44% to 47% cure rate. In search of more efficacious and convenient therapeutic options, a variety of lasers have been reported in the treatment of VV including the Nd:YAG laser (1064nm). Lasers offer the potential for decreased treatment associated pain, fewer office visits, higher cure rates and lower recurrence rates. However, many of the available published studies draw conclusions from case reports and small case series without any randomized controlled trials. A randomized, controlled study is needed to evaluate the efficacy of the microsecond Nd:YAG (1064nm) compared to conventional cryotherapy. This study will use the Cutera CoolGlide Nd:YAG laser that operates in the infrared spectrum at a wavelength of 1064nm. This a single site, double blind, randomized controlled clinical trial to evaluate the efficacy of the Nd:YAG laser (Cutera) in the treatment of verruca vulgaris of the hands and feet versus conventional liquid nitrogen therapy. The investigators hypothesize that there will be a significantly higher number of warts with complete resolution at 4 months follow-up in the Nd:YAG treated group versus the liquid nitrogen therapy group. The investigators also hypothesize that there will be a faster time to complete resolution of the verruca in the Nd:YAG treated group versus the liquid nitrogen treated group.

Conditions

Verruca Vulgaris

Keywords

verruca vulgaris; hands; feet; Nd:YAG; laser; cryotherapy

Outcome Measures

Primary Outcomes (1)

• Wart clearance

  Patients are treated with either arm of the study every 2 weeks for a total of 10 weeks (5 treatments) or until their warts clear. Patients whose warts clear are then followed up at 1 month and 2 months in person and then at 4 months by phone.

  ~ 6 months

Secondary Outcomes (1)

• Time to clearance

  ~6 months

Study Arms (2)

Liquid Nitrogen Cryotherapy

ACTIVE COMPARATOR

Every two weeks for a total of 5 treatments or until the patient clears, patients in the cryotherapy arm will be treated with 5-7 seconds of freeze time maintaining a 1mm freeze halo around the wart.

Procedure: Liquid Nitrogen Cryotherapy

Pulsed 1064nm Nd:YAG

EXPERIMENTAL

Every 2 weeks for a total of five treatments or until the wart clears, patients in the laser arm will be treated with the Nd:YAG. The settings will be 180J, 20ms pulse width and 5mm spot size. For warts 3mm or less, a 3mm spot size will be used, 180J and 15ms. If the patient reports no response after treatment, including crusting or blistering, the energy will be increased by 10 J until 200J has been reached.

Procedure: Pulsed 1064nm Nd:YAG

Interventions

Liquid Nitrogen Cryotherapy PROCEDURE

Every two weeks for a total of 5 treatments or until the patient clears, patients in the cryotherapy arm will be treated with 5-7 seconds of freeze time maintaining a 1mm freeze halo around the wart.

Also known as: cryotherapy

Liquid Nitrogen Cryotherapy

Pulsed 1064nm Nd:YAG PROCEDURE

Every 2 weeks for a total of five treatments or until the wart clears, patients in the laser arm will be treated with the Nd:YAG. The settings will be 180J, 20ms pulse width and 5mm spot size. For warts 3mm or less, a 3mm spot size will be used, 180J and 15ms. If the patient reports no response after treatment, including crusting or blistering, the energy will be increased by 10 J until 200J has been reached.

Also known as: laser

Pulsed 1064nm Nd:YAG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult males or females, ages 18 - 75
• Fitzpatrick skin types 1-6
• Patient is able to read and understand English and will give written informed consent to participate.
• Patient elects to undergo laser therapy or conventional therapy with liquid nitrogen for the treatment of verruca vulgaris.
• Clinical evidence of at least one verruca vulgaris, but no more than ten that have not received treatment for at least one month prior to their study start date.
• Warts to be treated will be located only on the hands or the feet.

You may not qualify if:

• Less than 18 years of age or greater than 75 years of age.
• Non-English speaking people, who cannot read, understand and sign the consent.
• Pregnant females.
• Any form of prior treatment to the area within the last 1 month.
• Immunosuppressed patients including patients with internal malignancy, on immunosuppressive drugs (including oral steroids), HIV positive or history of connective tissue disease (ie. SLE, DM, Scleroderma).
• Patients undergoing light therapy including NBUVB, PUVA, high UVB will be excluded from the study until their treatment is complete.
• Allergy to any components of the topical lidocaine (LMX, 4% lidocaine).

Sponsors & Collaborators

• Trinity Health Michigan: lead

Study Sites (1)

St. Joseph Mercy Hospital

Ypsilanti, Michigan, 48197, United States

Location

Related Publications (11)

• El-Tonsy MH, Anbar TE, El-Domyati M, Barakat M. Density of viral particles in pre and post Nd: YAG laser hyperthermia therapy and cryotherapy in plantar warts. Int J Dermatol. 1999 May;38(5):393-8. doi: 10.1046/j.1365-4362.1999.00719.x.

  PMID: 10369554 BACKGROUND

• Robson KJ, Cunningham NM, Kruzan KL, Patel DS, Kreiter CD, O'Donnell MJ, Arpey CJ. Pulsed-dye laser versus conventional therapy in the treatment of warts: a prospective randomized trial. J Am Acad Dermatol. 2000 Aug;43(2 Pt 1):275-80. doi: 10.1067/mjd.2000.106365.

  PMID: 10906651 BACKGROUND

• Kuykendall-Ivy TD, Johnson SM. Evidence-based review of management of nongenital cutaneous warts. Cutis. 2003 Mar;71(3):213-22.

  PMID: 12661750 BACKGROUND

• Park JH, Hwang ES, Kim SN, Kye YC. Er:YAG laser treatment of verrucous epidermal nevi. Dermatol Surg. 2004 Mar;30(3):378-81. doi: 10.1111/j.1524-4725.2004.30104.x.

  PMID: 15008864 BACKGROUND

• Tan OT, Hurwitz RM, Stafford TJ. Pulsed dye laser treatment of recalcitrant verrucae: a preliminary report. Lasers Surg Med. 1993;13(1):127-37. doi: 10.1002/lsm.1900130120.

  PMID: 8426521 BACKGROUND

• Gooptu C, James MP. Recalcitrant viral warts: results of treatment with the KTP laser. Clin Exp Dermatol. 1999 Mar;24(2):60-3. doi: 10.1046/j.1365-2230.1999.00418.x.

  PMID: 10233653 BACKGROUND

• Kopera D. Verrucae vulgares: flashlamp-pumped pulsed dye laser treatment in 134 patients. Int J Dermatol. 2003 Nov;42(11):905-8. doi: 10.1046/j.1365-4362.2003.01994.x.

  PMID: 14636211 BACKGROUND

• Han TY, Lee JH, Lee CK, Ahn JY, Seo SJ, Hong CK. Long-pulsed Nd:YAG laser treatment of warts: report on a series of 369 cases. J Korean Med Sci. 2009 Oct;24(5):889-93. doi: 10.3346/jkms.2009.24.5.889. Epub 2009 Sep 23.

  PMID: 19794989 BACKGROUND

• Gibbs S, Harvey I. Topical treatments for cutaneous warts. Cochrane Database Syst Rev. 2006 Jul 19;(3):CD001781. doi: 10.1002/14651858.CD001781.pub2.

  PMID: 16855978 BACKGROUND

• Killip S, Mahfoud Z, Pearce K. What is an intracluster correlation coefficient? Crucial concepts for primary care researchers. Ann Fam Med. 2004 May-Jun;2(3):204-8. doi: 10.1370/afm.141.

  PMID: 15209195 BACKGROUND

• Sterling JC, Handfield-Jones S, Hudson PM; British Association of Dermatologists. Guidelines for the management of cutaneous warts. Br J Dermatol. 2001 Jan;144(1):4-11. doi: 10.1046/j.1365-2133.2001.04066.x.

  PMID: 11167676 BACKGROUND

Related Links

• Educational information about warts
• Educational information about warts.

MeSH Terms

Conditions

Warts

Interventions

Cryotherapy; Heart Rate; Lasers

Condition Hierarchy (Ancestors)

Papillomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Tumor Virus Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Barry Auster, MD

  Saint Joseph Mercy Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Using sealed envelope assignment, the participant will be placed in study Arm 1 or 2. The investigator will not be masked because the investigator will administer the standard of care cryotherapy or the experimental laser treatment. The outcome assessor will be masked to study group assignment for gathering data from trial participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Clinical Trail of standard cryotherapy compared with laser treatment

Study Record Dates

• First Submitted: May 29, 2012
• First Posted: June 1, 2012
• Study Start: January 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: March 22, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)