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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Saint Joseph Mercy Health System
ClinicalTrials.gov Identifier:
NCT01609530
First received: May 29, 2012
Last updated: May 13, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Verruca Vulgaris
Procedure: Liquid Nitrogen Cryotherapy
Procedure: Pulsed 1064nm Nd:YAG
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Double Blind Study Comparing Liquid Nitrogen Cryotherapy With Nd:YAG in the Treatment of Verruca Vulgaris

Resource links provided by NLM:


Further study details as provided by Saint Joseph Mercy Health System:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 31
Study Start Date: January 2012
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult males or females, ages 18 - 75
  2. Fitzpatrick skin types 1-6
  3. Patient is able to read and understand English and will give written informed consent to participate.
  4. Patient elects to undergo laser therapy or conventional therapy with liquid nitrogen for the treatment of verruca vulgaris.
  5. 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.
  6. Warts to be treated will be located only on the hands or the feet.

Exclusion Criteria:

  1. Less than 18 years of age or greater than 75 years of age.
  2. Non-English speaking people, who cannot read, understand and sign the consent.
  3. Pregnant females.
  4. Any form of prior treatment to the area within the last 1 month.
  5. 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).
  6. Patients undergoing light therapy including NBUVB, PUVA, high UVB will be excluded from the study until their treatment is complete.
  7. Allergy to any components of the topical lidocaine (LMX, 4% lidocaine).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01609530

Locations
United States, Michigan
St. Joseph Mercy Hospital
Ypsilanti, Michigan, United States, 48197
Sponsors and Collaborators
Saint Joseph Mercy Health System
Investigators
Principal Investigator: Barry Auster, MD Saint Joseph Mercy Hospital
  More Information

Additional Information:
Publications:

Responsible Party: Saint Joseph Mercy Health System
ClinicalTrials.gov Identifier: NCT01609530     History of Changes
Other Study ID Numbers: HSR 11-1215
Study First Received: May 29, 2012
Last Updated: May 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Saint Joseph Mercy Health System:
verruca
vulgaris
hands
feet
Nd:YAG
laser
cryotherapy

Additional relevant MeSH terms:
Warts
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Tumor Virus Infections
Neoplasms
Skin Diseases, Infectious
Skin Diseases

ClinicalTrials.gov processed this record on August 25, 2014