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Oral Zinc Gluconate as Treatment for Recalcitrant Cutaneous Warts: A Randomized, Double-blind, Placebo-controlled Trial

NCT ID: NCT01783353

Last Updated: 2013-11-14

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

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2013-09-30

Brief Summary

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Up to one-third of common warts can remain recalcitrant, an occurrence that has been attributed to impaired cell-mediated immunity. At present, no guidelines exist for the management of recalcitrant cutaneous warts. Zinc, a well-established immunomodulatory agent, has shown promise in this regard. Previous studies documenting the efficacy of oral zinc used zinc sulfate given at a maximum dose of 600 mg/day, equivalent to 140 mg of elemental zinc, which is over three times the recommended upper limit of 40 mg of elemental zinc per day. This raises concerns over safety and tolerability. In the Philippines, oral zinc is more widely available in chelated forms such as zinc gluconate, which have the benefit of improved absorption compared to non-chelated compounds such as zinc sulfate. This study will seek to determine if zinc gluconate 300 mg/day, equivalent to 40 mg of elemental zinc, will be efficacious in treating recalcitrant cutaneous warts. This lowered dose may have the added benefits of increased safety, tolerability, and cost-effectiveness.

Detailed Description

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Conditions

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Recalcitrant Cutaneous Warts

Keywords

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Recalcitrant cutaneous warts verruca

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Corn starch pill

Two (2) corn starch pills will be taken three (3) times a day for 60 days.

Group Type PLACEBO_COMPARATOR

Corn starch pill

Intervention Type DIETARY_SUPPLEMENT

Zinc gluconate

Two (2) zinc gluconate 50 mg capsules will be taken three (3) times a day for 60 days.

Group Type EXPERIMENTAL

Zinc gluconate

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Zinc gluconate

Intervention Type DIETARY_SUPPLEMENT

Corn starch pill

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

1. Male or non-pregnant female
2. Age 19 years and older
3. With ≥ one (1) recalcitrant common, mosaic, palmar, plantar, or periungual wart/s
4. Consent given

Exclusion Criteria

1. Current or history of mental illness
2. Current or history of malignancy
3. Severe immunodeficiency states
4. Pregnant or lactating
5. Documented adverse effects to oral or topical zinc exposure
6. Oral intake of zinc supplements in the past 12 months or less
7. Oral Intake of H2 antagonists in the past 4 weeks or less
8. Oral intake of immunosuppressives in the past 4 weeks or less
9. Concurrent usage of other treatment modalities
10. Current anogenital warts
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Philippine Dermatological Society

NETWORK

Sponsor Role lead

Responsible Party

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Rochelle L. Castillo

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rochelle L. Castillo, M.D.

Role: PRINCIPAL_INVESTIGATOR

Philippine General Hospital Section of Dermatology

Locations

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Philippine General Hospital

Manila, NCR, Philippines

Site Status

Countries

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Philippines

Other Identifiers

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PDS_PGH_2013_001

Identifier Type: -

Identifier Source: org_study_id