Laser Versus Cryotherapy for the Treatment of Recalcitrant Warts

NCT ID: NCT05616078

Last Updated: 2022-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-30

Study Completion Date

2025-11-30

Brief Summary

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To evaluate whether laser was superior to cryotherapy for recalcitrant warts

Detailed Description

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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.

Conditions

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Warts

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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laser treatment

LP-Nd:YAG laser treatment

Group Type EXPERIMENTAL

laser treatment

Intervention Type OTHER

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

cryotherapy

cryotherapy with liquid nitrogen

Group Type ACTIVE_COMPARATOR

cryotherapy

Intervention Type OTHER

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

Interventions

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laser treatment

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

Intervention Type OTHER

cryotherapy

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The 306 Hospital of People's Liberation Army

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shichao Lu, MD

Role: PRINCIPAL_INVESTIGATOR

The 306 Hospital of People's Liberation Army

Central Contacts

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Shichao Lu, MD

Role: CONTACT

8610-010-66356984

Other Identifiers

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306PLA-004

Identifier Type: -

Identifier Source: org_study_id

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