Laser Versus Cryotherapy for the Treatment of Recalcitrant Warts

Warts Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05616078
• Other study ID #: 306PLA-004
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2022
• Est. completion date: November 2025

Study information

• Verified date: November 2022
• Source: The 306 Hospital of People's Liberation Army
• Contact: Shichao Lu, MD
• Phone: 8610-010-66356984
• Email: lvshichao[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate whether laser was superior to cryotherapy for recalcitrant warts

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 110
• Est. completion date: November 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Warts

Intervention

Other:
• laser treatment
a maximum of 4 sessions, with an interval of 3 to 4 weeks
• cryotherapy
a maximum of 4 sessions, with an interval of 3 to 4 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The 306 Hospital of People's Liberation Army

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	time to clearance of warts	The time from treatment initiation until clearance of all warts	16 weeks since the initial treatment
Secondary	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
Secondary	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