NCT01783353

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2013

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

January 30, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 4, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

November 14, 2013

Status Verified

November 1, 2013

Enrollment Period

8 months

First QC Date

January 30, 2013

Last Update Submit

November 13, 2013

Conditions

Recalcitrant Cutaneous Warts

Keywords

Recalcitrant cutaneous wartsverruca

Outcome Measures

Primary Outcomes (1)

  • Efficacy based on the resolution rate (i.e. the percentage of baseline warts that resolve completely) on Days 30 and 60

    60 days

Secondary Outcomes (3)

  • Types of adverse events

    60 days

  • Severity of adverse events

    60 days

  • Recurrence

    120 days

Study Arms (2)

Corn starch pill

PLACEBO COMPARATOR

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

Dietary Supplement: Corn starch pill

Zinc gluconate

EXPERIMENTAL

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

Dietary Supplement: Zinc gluconate

Interventions

Zinc gluconateDIETARY_SUPPLEMENT
Zinc gluconate
Corn starch pillDIETARY_SUPPLEMENT
Corn starch pill

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Current or history of mental illness
  • Current or history of malignancy
  • Severe immunodeficiency states
  • Pregnant or lactating
  • Documented adverse effects to oral or topical zinc exposure
  • Oral intake of zinc supplements in the past 12 months or less
  • Oral Intake of H2 antagonists in the past 4 weeks or less
  • Oral intake of immunosuppressives in the past 4 weeks or less
  • Concurrent usage of other treatment modalities
  • Current anogenital warts

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Philippine General Hospital

Manila, NCR, 1000, Philippines

Location

MeSH Terms

Conditions

Warts

Interventions

gluconic acidStarch

Condition Hierarchy (Ancestors)

Papillomavirus InfectionsDNA Virus InfectionsVirus DiseasesInfectionsSkin Diseases, ViralTumor Virus InfectionsSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

GlucansBiopolymersPolymersMacromolecular SubstancesDietary CarbohydratesCarbohydratesPolysaccharides

Study Officials

  • Rochelle L. Castillo, M.D.

    Philippine General Hospital Section of Dermatology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

January 30, 2013

First Posted

February 4, 2013

Study Start

January 1, 2013

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

November 14, 2013

Record last verified: 2013-11

Locations

PH(1)