Laser Versus Cryotherapy for the Treatment of Recalcitrant Warts

Laser Versus Cryotherapy for the Treatment of Recalcitrant Warts: a Randomised Controlled Trial

To evaluate whether laser was superior to cryotherapy for recalcitrant warts

Study Overview

• Status: Not yet recruiting
• Conditions: Warts
• Intervention / Treatment: Other: laser treatment; Other: cryotherapy

Detailed Description

Patients with recalcitrant warts were randomized equally to receive laser or cryotherapy every 3 to 4 weeks, for a maximum of 4 sessions.The primary outcomes were the cure rate at 16 weeks; secondary outcomes included time to clearance of warts, patient satisfaction with the treatment and treatment-related adverse effects.

• Study Type: Interventional
• Enrollment (Anticipated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shichao Lu, MD; Phone Number: 8610-010-66356984; Email: lvshichao@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with HPV2/27/57-induced recalcitrant warts, including periungualor mosaic warts, common or plantar warts with a duration of longer than 1 year, and common or plantar warts previously received no more than two sessions of cryotherapy
• Total number of warts is ≤10 .
• Aged 18 years or older.

Exclusion Criteria:

• Patients are currently participating in another trial for the treatment of cutaneous warts.
• Patients have taken immunosuppressant drugs (such as oral corticosteroids) during the past three months.
• Patients have impaired healing eg due to diabetes, vitamin A deficiency, hyperthyroidism and hypothyroidism.
• Patients have autoimmune diseases (such as systemic lupus erythematosus, dermatomyositis, scleroderma or other diseases).
• Patients are pregnant or ready for pregnancies or breast-feeding.
• Patients have cold intolerance (such as cold urticaria, cryoglobulinaemia, cold agglutinin syndrome or Raynaud's syndrome).
• Patients have local pain intolerance.
• Patients have local hypoesthesia.
• Patients are unable to tolerate laser or cryotherapy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: laser treatment; LP-Nd:YAG laser treatment	Other: laser treatment; a maximum of 4 sessions, with an interval of 3 to 4 weeks
Active Comparator: cryotherapy; cryotherapy with liquid nitrogen	Other: cryotherapy; a maximum of 4 sessions, with an interval of 3 to 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cure rate at 16 weeks	A patient was considered to be cured if all warts were no longer visible and could not be palpated anymore.	16 weeks since the initial treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time to clearance of warts	The time from treatment initiation until clearance of all warts	16 weeks since the initial treatment
patient satisfaction with the treatment	Patient satisfaction was rated on a 5-point scale (from very happy to very unhappy)	16 weeks since the initial treatment
treatment-related adverse events	Some adverse effects, including pain, swelling, blisters, hemorrhagic bullae, bruising, and skin breakdown, were recorded by the patients, whereas others, including secondary bacterial infection, hyperpigmentation, hypopigmentation, and scarring were evaluated by a dermatologist	16 weeks since the initial treatment

Collaborators and Investigators

• Sponsor: The 306 Hospital of People's Liberation Army
• Investigators: Principal Investigator: Shichao Lu, MD, The 306 Hospital of People's Liberation Army

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2022
• Primary Completion (Anticipated): November 1, 2025
• Study Completion (Anticipated): November 1, 2025

Study Registration Dates

• First Submitted: November 1, 2022
• First Submitted That Met QC Criteria: November 7, 2022
• First Posted (Actual): November 15, 2022

Study Record Updates

• Last Update Posted (Actual): November 15, 2022
• Last Update Submitted That Met QC Criteria: November 7, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Virus Diseases; Infections; DNA Virus Infections; Skin Diseases, Infectious; Papillomavirus Infections; Skin Diseases, Viral; Tumor Virus Infections; Warts
• Other Study ID Numbers: 306PLA-004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No