Laser Versus Cryotherapy for the Treatment of Recalcitrant Warts

Not Applicable

Not yet recruiting

• Conditions: Warts
• Interventions: Other: cryotherapy; Other: laser treatment

• Registration Number: NCT05616078
• Lead Sponsor: The 306 Hospital of People's Liberation Army

Brief Summary

To evaluate whether laser was superior to cryotherapy for recalcitrant warts

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 Timeline

• Status Verified: 2022-11
• Study Start: 2022-11
• Study First Submitted: 2022-11-01
• Study First Submitted QC: 2022-11-07
• Last Update Submitted: 2022-11-07
• Study First Posted: 2022-11-15
• Last Update Posted: 2022-11-15
• Primary Completion: 2025-11
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 110

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cryotherapy	cryotherapy	cryotherapy with liquid nitrogen
laser treatment	laser treatment	LP-Nd:YAG laser treatment

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
time to clearance of warts	16 weeks since the initial treatment	The time from treatment initiation until clearance of all warts
patient satisfaction with the treatment	16 weeks since the initial treatment	Patient satisfaction was rated on a 5-point scale (from very happy to very unhappy)
treatment-related adverse events	16 weeks since the initial treatment	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