Efficacy of Laser Versus Cryotherapy in the Treatment of Warts

NCT01808443 | Completed DMC

• 1 other identifier: 306PLA-001
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Warts

Keywords

cryotherapy; laser; cutaneous warts

Outcome Measures

Primary Outcomes (1)

• cure rate

  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

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

Secondary Outcomes (8)

• effective rate

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

• recurrence rate

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

• average cure days

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

• side effects

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

• pain intensity

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

Study Arms (2)

Cryotherapy

ACTIVE COMPARATOR

Cryotherapy, at most 4 times

Other: Cryotherapy

laser

EXPERIMENTAL

laser, at most 4 times

Other: laser

Interventions

Cryotherapy OTHER

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

Cryotherapy

laser OTHER

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

laser

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The 306 Hospital of People's Liberation Army: lead
• Peking University: collaborator

Study Sites (1)

The 306 Hospital of PLA

Beijing, 100101, China

Location

MeSH Terms

Conditions

Warts

Interventions

Cryotherapy; Lasers

Condition Hierarchy (Ancestors)

Papillomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Tumor Virus Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Shichao Lu, MD

  Dermatology Deparment of the 306 Hospital of PLA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: March 7, 2013
• First Posted: March 11, 2013
• Study Start: March 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2016
• Last Updated: November 6, 2019

Record last verified: 2019-11

Locations

CN (1)