Laser Versus Cryotherapy for the Treatment of Recalcitrant Warts

Sponsor
The 306 Hospital of People's Liberation Army (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05616078
Collaborator
(none)
110
2
36

Study Details

Study Description

Brief Summary

To evaluate whether laser was superior to cryotherapy for recalcitrant warts

Condition or Disease Intervention/Treatment Phase
  • Other: laser treatment
  • Other: cryotherapy
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
110 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Laser Versus Cryotherapy for the Treatment of Recalcitrant Warts: a Randomised Controlled Trial
Anticipated Study Start Date :
Nov 1, 2022
Anticipated Primary Completion Date :
Nov 1, 2025
Anticipated Study Completion Date :
Nov 1, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. time to clearance of warts [16 weeks since the initial treatment]

    The time from treatment initiation until clearance of all warts

  2. 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)

  3. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • The 306 Hospital of People's Liberation Army

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The 306 Hospital of People's Liberation Army
ClinicalTrials.gov Identifier:
NCT05616078
Other Study ID Numbers:
  • 306PLA-004
First Posted:
Nov 15, 2022
Last Update Posted:
Nov 15, 2022
Last Verified:
Nov 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 15, 2022