Pulsed 1064nm Nd:YAG in the Treatment of Verruca Vulgaris Versus Conventional Therapy With Liquid Nitrogen Cryotherapy
|First Received Date ICMJE||May 29, 2012|
|Last Updated Date||May 31, 2012|
|Start Date ICMJE||January 2012|
|Estimated Primary Completion Date||September 2013 (final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
||Wart clearance [ Time Frame: ~ 6 months ] [ Designated as safety issue: No ]
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.
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT01609530 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||Time to clearance [ Time Frame: ~6 months ] [ Designated as safety issue: No ]
Time to clearance will be calculated based on the number of treatments needed to clear the wart.
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Pulsed 1064nm Nd:YAG in the Treatment of Verruca Vulgaris Versus Conventional Therapy With Liquid Nitrogen Cryotherapy|
|Official Title ICMJE||Randomized Double Blind Study Comparing Liquid Nitrogen Cryotherapy With Nd:YAG in the Treatment of Verruca Vulgaris|
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.
Outcome measures: The primary outcome will be complete resolution of the lesion defined as: clinical absence of verruca vulgaris with redevelopment of skin lines on the dorsal surface and dermatoglyphics (ridges of the skin) on the inner surface of the palms and feet, as determined by a blinded clinician investigator blinded to the treatment will evaluate each lesion and determine whether the lesion. A secondary outcome will include: time to complete resolution of the lesion.
2. Objectives and Specific Aims 1.1. Primary objective: To evaluate the efficacy of the Cutera CoolGlide 1064nm Nd:YAG laser in the treatment of verruca vulgaris of the hands and feet versus conventional therapy with liquid nitrogen cryotherapy.
2. Research Design and Methods This a single site double blind (faculty observer and patient blinded; operator/clinician non-blinded), 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 therapy with liquid nitrogen in 52 patients.
2.2 Study Procedures Informed consent A signed informed consent form will be obtained from each patient prior to entering the study
Physical examination A brief physical examination of the skin including the affected area will be performed. Photographs will be taken of affected areas, prior to and after each treatment from baseline through the fifth treatment follow-up. The investigator will document the number, size and location of each lesion.
Laboratory tests No laboratory testing will be performed for this research project.
Initial Visit (DAY 1):
Prior to the clinic visit and treatment:
8. The patients that have been randomly selected to receive Nd:YAG laser treatment will be fully treated with the following parameters for the laser. If the warts are greater than 3mm the following settings will be used: 20 millisecond pulse width, fluence 180 J/cm2, spot size 5 mm. If warts are 3mm or less in diameter, the laser settings will be: 180 J/cm2, spot size 3mm, pulse width 15 milliseconds. No laser gel will be used during treatment. After each laser pulse, the treated area can be briefly cooled with the tip of the laser. If more than one pulse is needed to cover the entire area of the wart, 10% overlap will be used and area outside of the wart border will not be treated.
9. The patients that have been randomly selected to receive liquid nitrogen treatment will receive liquid nitrogen spray gun for 5-7 seconds creating and maintaining a 1-2 mm freeze halo around lesion for the duration of the application. Use nozzle extender for warts less than 3 mm.
10. Patients will be instructed to avoid treating the warts at home, but they may use vaseline, aquaphor, or plain petrolatum and a band aid as needed for comfort until the next visit .
11. Patients will schedule a return visit in two weeks for assessment of the effects of treatment.
12. Patient treatments will be documented on the appropriate Dermatology Study Wart Treatment Record (Appendix D). Revision of the Dermatology Study Wart Treatment Record is attached with the Request for Revision.
12.1 Document the patient's medications on the Master Medication Record 12.2 Document the patient's warts on the Master Record of Warts
Follow-Up Phase: Clinical Clearance Once a lesion is clinically clear, the patient will move on to the follow up phase. No lesion will be treated more than 5 times. Patients who do not clear after the evaluation of the 5th treatment will be considered treatment failure and will be removed from the study. Patients who fail study treatment will be offered continuing treatment outside of the study through Dermatology Clinic. The patient will be responsible for standard charges for any additional treatment through Dermatology Clinic.
Patients who clear will return to the clinic for evaluation at 1 and 2 months after clinical clearance to determine continued clearance or recurrence. Recurrence will be defined as a new clinical evident lesion that appear in the same location(s) as the previously treated wart(s) up to 2 months post treatment.
1 and 2 Month Follow Up
4 Month Follow-up
At 4 months following the clearance date, a structured telephone interview will investigate the status of the lesion(s). If the patient is unsure of the status of clearance, the patient will be asked to return for evaluation by the sub-investigator. If the wart recurs or persists, the patient will be offered additional treatment using other options and will be billed for any post-study treatment.
3. Data management and statistical analysis Data Collection and management Data will be collected on paper Case Report forms by the resident physician treating the subject. See data collection tools (Appendix D) and rules in the Procedure Book. Double data entry will be provided by data entry staff into two separate excel spread sheets. Data comparison will be completed by the research statistician. Any discrepancies will be reviewed by the study team. Issues in need of adjudication will be decided by the PI.
Sample size determination: Sample size was calculated based on a formula for effective sample size in a randomized clustered design with binary outcomes. On average, patients will present with approximately three lesions (usually between 1 and 5) requiring treatment. An estimate of a 50% cure rate, using cryotherapy for plantar warts, was drawn from a Cochrane review published in 2006 [10, 11]. We will consider a clinically significant improvement, if at least 80% of the warts treated by Nd:Yag laser are completely resolved at the 6 month visit. We will assume a moderate intra-cluster correlation coefficient of 0.3. Given the cluster design, enrolling 52 patients with, on average, 3 warts each, randomized to one of two treatments, will be needed to provide 84% power to show a statistically significant difference in cure rate. Significance will be set at p<0.05.
Data Management and Analysis All analyses will be done using SAS® 9.2. Demographic and clinical variables will be summarized using means, medians and percentages, as appropriate. To determine whether the primary outcome, complete resolution of each lesion at 2 and 4 months follow-up, is different between treatment groups, we will use a generalized linear mixed model with a binomial distribution, and with initial lesion size and duration, as covariates in the model. The correlation of outcomes within patient will be modeled using a random effect. The secondary outcome, time to complete resolution will be analyzed using a using a multilevel survival model with patient as a random effect and initial lesion size and duration as covariates in the model. To see whether the results are sensitive to missing data, both models will be analyzed with and without the self-reported 4-month outcomes.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 4|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
|Condition ICMJE||Verruca Vulgaris|
|Study Arm (s)||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||52|
|Estimated Completion Date||March 2014|
|Estimated Primary Completion Date||September 2013 (final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
|Ages||18 Years to 75 Years|
|Accepts Healthy Volunteers||No|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT01609530|
|Other Study ID Numbers ICMJE||HSR 11-1215|
|Has Data Monitoring Committee||Yes|
|Responsible Party||Saint Joseph Mercy Health System|
|Study Sponsor ICMJE||Saint Joseph Mercy Health System|
|Collaborators ICMJE||Not Provided|
|Information Provided By||Saint Joseph Mercy Health System|
|Verification Date||May 2012|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP