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Completed

NCT Number: NCT01808443

Efficacy of Laser Versus Cryotherapy in the Treatment of Warts

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The 306 Hospital of PLA

Beijing, 100101, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cryotherapy

Other

up to a maximum of four treatments every 21-28 days

laser

Other

up to a maximum of four treatments every 21-28 days

Primary outcomes

  1. cure rate

    Time frame: Cure rate will be calculated at 16 weeks and 6 months from the first treatment

    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 outcomes

  1. effective rate

    Time frame: Effective rate will be calculated at 16 weeks from the first treatment

    Effective assessment is performed by a senior dermatologist.

  2. recurrence rate

    Time frame: Recurrence rate will be calculated at 12 months from the first treatment

    A wart was considered recurrence if there are abnormalities or palpated foreign body in the original place.

  3. average cure days

    Time frame: Average cure days will be calculated at 6 months from the first treatment

    Cure days was defined as the period from the first treatment until the date of clearance.

  4. side effects

    Time frame: Side effects will be assessed within 3-4 weeks after each treatment

    including pain, swelling, blisters, blood blisters, bruising, bleeding,scarring, hypopigmentation, hyperpigmentation.

  5. pain intensity

    Time frame: Pain intensity will be assessed within 3-4 weeks after each treatment

    on a scale of 0-10, where 0 is no pain and 10 is extremely painful

  6. patient satisfaction

    Time frame: Patient satisfactionwill be assessed within 3-4 weeks after each treatment

    on a five-point scale, from 'very satisfied' to 'very satisfied'

  7. treatment costs

    Time frame: Treatment costs will be recorded within 10 minutes after each treatment

    record the cost after each treatment

  8. 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

    take a small amount of cutaneous warts lesions and extract HPV DNA before treatment

Sponsors and collaborators

Lead sponsor

The 306 Hospital of People's Liberation Army

Other

Collaborators

  • Peking University

Registry information

Official study title

Cryotherapy Versus Laser for the Treatment of Nongenital Cutaneous Warts: A Randomized Controlled Clinical Trial

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Mar 11, 2013
Registry last updated
Nov 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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