Laser Versus Cryotherapy for the Treatment of Recalcitrant Warts

NCT05616078 | Unknown

• 1 other identifier: 306PLA-004
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate whether laser was superior to cryotherapy for recalcitrant warts

Conditions

Warts

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• time to clearance of warts

  16 weeks since the initial treatment

• patient satisfaction with the treatment

  16 weeks since the initial treatment

• treatment-related adverse events

  16 weeks since the initial treatment

Study Arms (2)

laser treatment

EXPERIMENTAL

LP-Nd:YAG laser treatment

Other: laser treatment

cryotherapy

ACTIVE COMPARATOR

cryotherapy with liquid nitrogen

Other: cryotherapy

Interventions

laser treatment OTHER

a maximum of 4 sessions, with an interval of 3 to 4 weeks

laser treatment

cryotherapy OTHER

a maximum of 4 sessions, with an interval of 3 to 4 weeks

cryotherapy

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

MeSH Terms

Conditions

Warts

Interventions

Laser Therapy; Cryotherapy

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; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Shichao Lu, MD

  The 306 Hospital of People's Liberation Army

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shichao Lu, MD

CONTACT

8610-010-66356984; lvshichao@sina.com

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: SPONSOR

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: November 15, 2022
• Study Start: November 1, 2022
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: November 15, 2022

Record last verified: 2022-11