Efficacy of Laser Versus Cryotherapy in the Treatment of Warts

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2013 by The 306 Hospital of People's Liberation Army
Sponsor:
Collaborator:
Peking University
Information provided by (Responsible Party):
Shichao Lu, The 306 Hospital of People's Liberation Army
ClinicalTrials.gov Identifier:
NCT01808443
First received: March 7, 2013
Last updated: March 8, 2013
Last verified: March 2013
  Purpose

The purpose of this study is to test the efficacy of laser versus cryotherapy on the treatment of warts


Condition Intervention Phase
Warts
Other: Cryotherapy
Other: laser
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cryotherapy Versus Laser for the Treatment of Nongenital Cutaneous Warts: A Randomized Controlled Clinical Trial

Resource links provided by NLM:


Further study details as provided by The 306 Hospital of People's Liberation Army:

Primary Outcome Measures:
  • cure rate [ Time Frame: Cure rate will be calculated at 16 weeks and 6 months from the first treatment ] [ Designated as safety issue: Yes ]
    Warts was considered cured if they was no longer visible and could not be palpated anymore by hand. Assessment of whether or not cured was performed on site by a senior dermatologist


Secondary Outcome Measures:
  • effective rate [ Time Frame: Effective rate will be calculated at 16 weeks from the first treatment ] [ Designated as safety issue: Yes ]
    Effective assessment is performed by a senior dermatologist.

  • recurrence rate [ Time Frame: Recurrence rate will be calculated at 12 months from the first treatment ] [ Designated as safety issue: Yes ]
    A wart was considered recurrence if there are abnormalities or palpated foreign body in the original place.

  • average cure days [ Time Frame: Average cure days will be calculated at 6 months from the first treatment ] [ Designated as safety issue: Yes ]
    Cure days was defined as the period from the first treatment until the date of clearance.

  • side effects [ Time Frame: Side effects will be assessed within 3-4 weeks after each treatment ] [ Designated as safety issue: Yes ]
    including pain, swelling, blisters, blood blisters, bruising, bleeding,scarring, hypopigmentation, hyperpigmentation.

  • pain intensity [ Time Frame: Pain intensity will be assessed within 3-4 weeks after each treatment ] [ Designated as safety issue: Yes ]
    on a scale of 0-10, where 0 is no pain and 10 is extremely painful

  • patient satisfaction [ Time Frame: Patient satisfactionwill be assessed within 3-4 weeks after each treatment ] [ Designated as safety issue: Yes ]
    on a five-point scale, from 'very satisfied' to 'very satisfied'

  • treatment costs [ Time Frame: Treatment costs will be recorded within 10 minutes after each treatment ] [ Designated as safety issue: Yes ]
    record the cost after each treatment

  • relationship between HPV type and curative effect [ Time Frame: Relationship between HPV type and curative effect will be analyzed at 16 weeks and 6 months from the first treatment ] [ Designated as safety issue: Yes ]
    take a small amount of cutaneous warts lesions and extract HPV DNA before treatment


Estimated Enrollment: 150
Study Start Date: March 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cryotherapy
Cryotherapy, at most 4 times
Other: Cryotherapy
up to a maximum of four treatments every 21-28 days
Experimental: laser
laser, at most 4 times
Other: laser
up to a maximum of four treatments every 21-28 days

Detailed Description:

Cutaneous warts were a common skin diseases caused by human papilloma virus (HPV) infection. Although warts may spontaneously resolve, many patients seek for treatment for various reasons. There are many kinds of treatments for cutaneous warts, including salicylic acid, cryotherapy, laser, etc. A recent high quality RCT confirmed that the cure rate of topical salicylic acid and frozen has no difference at six months, but the efficacy of laser versus cryotherapy on the treatment of warts remains unclear. Therefore, we designed a randomized controlled trial to test the efficacy of laser versus cryotherapy on the treatment of warts.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients have cutaneous warts, including common warts(d≥1cm or n≥5 ), plantar warts, periungual warts, mosaic warts, which are suitable for cryotherapy and laser treatment .
  • patients aged eighting years and over, who have junior school degree or above

Exclusion Criteria:

  • Patients who have more than 20 warts
  • Patients who are currently participating in another trial for the treatment of their warts
  • Patients who took immunosuppressant drugs such as oral corticosteroids within the past three months.
  • Patients who are pregnant or ready for pregnancies or breast-feeding.
  • Patients who have impaired healing eg due to diabetes, vascular disease, vitamin A deficiency, hyperthyroidism and hypothyroidism.
  • Patients who have autoimmune diseases, eg SLE, dermatomyositis, scleroderma and other diseases .
  • Patients who have cold intolerance, eg cold urticaria, cryoglobulinaemia, cold agglutinin syndrome, Raynaud's syndrome.
  • Patients who have local injections intolerance.
  • Patients who have local hypoesthesia .
  • Patients who can not tolerate cryotherapy or laser treatment for their own reasons.
  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: NCT01808443

Contacts
Contact: Shichao Lu, M.D. 8610-010-66356984 lvshichao@sina.com

Locations
China
The 306 Hospital of PLA Not yet recruiting
Beijing, China, 100101
Contact: Shichao Lu, M.D.         
Sponsors and Collaborators
The 306 Hospital of People's Liberation Army
Peking University
Investigators
Principal Investigator: Shichao Lu, MD Dermatology Deparment of the 306 Hospital of PLA
  More Information

No publications provided

Responsible Party: Shichao Lu, M.D., The 306 Hospital of People's Liberation Army
ClinicalTrials.gov Identifier: NCT01808443     History of Changes
Other Study ID Numbers: 306PLA-001
Study First Received: March 7, 2013
Last Updated: March 8, 2013
Health Authority: China: Ethics Committee

Keywords provided by The 306 Hospital of People's Liberation Army:
cryotherapy
laser
cutaneous warts

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 28, 2014