Pulsed 1064nm Nd:YAG in the Treatment of Verruca Vulgaris Versus Conventional Therapy With Liquid Nitrogen Cryotherapy
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.
|Verruca Vulgaris||Procedure: Liquid Nitrogen Cryotherapy Procedure: Pulsed 1064nm Nd:YAG||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Randomized Double Blind Study Comparing Liquid Nitrogen Cryotherapy With Nd:YAG in the Treatment of Verruca Vulgaris|
- Wart clearance [ Time Frame: ~ 6 months ]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.
- Time to clearance [ Time Frame: ~6 months ]Time to clearance will be calculated based on the number of treatments needed to clear the wart.
|Study Start Date:||January 2012|
|Study Completion Date:||March 2014|
|Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
|Experimental: Liquid Nitrogen Cryotherapy||
Procedure: Liquid Nitrogen Cryotherapy
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.
Other Name: cryotherapy
|Experimental: Pulsed 1064nm Nd:YAG||
Procedure: Pulsed 1064nm Nd:YAG
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.
Other Name: laser
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01609530
|United States, Michigan|
|St. Joseph Mercy Hospital|
|Ypsilanti, Michigan, United States, 48197|
|Principal Investigator:||Barry Auster, MD||Saint Joseph Mercy Hospital|