Pulsed 1064nm Nd:YAG in the Treatment of Verruca Vulgaris Versus Conventional Therapy With Liquid Nitrogen Cryotherapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01609530|
Recruitment Status : Completed
First Posted : June 1, 2012
Last Update Posted : May 15, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Verruca Vulgaris||Procedure: Liquid Nitrogen Cryotherapy Procedure: Pulsed 1064nm Nd:YAG||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Randomized Double Blind Study Comparing Liquid Nitrogen Cryotherapy With Nd:YAG in the Treatment of Verruca Vulgaris|
|Study Start Date :||January 2012|
|Primary Completion Date :||March 2014|
|Study Completion Date :||March 2014|
|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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01609530
|United States, Michigan|
|St. Joseph Mercy Hospital|
|Ypsilanti, Michigan, United States, 48197|
|Principal Investigator:||Barry Auster, MD||Saint Joseph Mercy Hospital|