Salicylic Acid Versus Cryotherapy for the Treatment of HPV1-induced Plantar Warts

NCT05617950 | Unknown

• 1 other identifier: 306PLA-005
• Study Type: interventional
• Target: 174
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate whether salicylic acid was superior to cryotherapy for plantar warts

Conditions

Warts

Outcome Measures

Primary Outcomes (1)

• cure rate at 12 weeks

  A patient was considered to be cured if all warts were no longer visible and could not be palpated anymore.

  12 weeks since the initial treatment

Secondary Outcomes (3)

• time to clearance of warts

  12 weeks since the initial treatment

• patient satisfaction with the treatment

  12 weeks since the initial treatment

• treatment-related adverse events

  12 weeks since the initial treatment

Study Arms (2)

salicylic acid

EXPERIMENTAL

30% salicylic acid

Other: salicylic acid

cryotherapy

ACTIVE COMPARATOR

liquid nitrogen

Other: cryotherapy

Interventions

salicylic acid OTHER

Salicylic acid is applied once daily by the patients (or parents) for a maximum of 12 weeks.

salicylic acid

cryotherapy OTHER

Cryotherapy is delivered by a technician up to a maximum of four treatments 3 weeks apart.

cryotherapy

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with HPV1-induced plantar warts.
• Total number of warts is ≤5.
• Aged 12 years or older.

You may not qualify if:

• Patients are currently participating in another trial for the treatment of plantar 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 salicylic acid or cryotherapy.

Sponsors & Collaborators

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

MeSH Terms

Conditions

Warts

Interventions

Salicylic Acid; 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)

Salicylates; Hydroxybenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Therapeutics

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 16, 2022
• Study Start: November 1, 2022
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: November 16, 2022

Record last verified: 2022-11