Recalcitrant Cutaneous WartsPhase 2/3NCT01783353
Oral Zinc Gluconate as Treatment for Recalcitrant Cutaneous Warts: A Randomized, Double-blind, Placebo-controlled Trial
A Phase 2/3 study testing Zinc gluconate and Corn starch pill in people with Recalcitrant Cutaneous Warts, run by Philippine Dermatological Society at 1 site in Philippines.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Recalcitrant Cutaneous Warts
- What is being tested?
- Zinc gluconate and Corn starch pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 sitePhilippines
- Study dates
- Jan 2013to Sep 2013
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or non-pregnant female
- Age 19 years and older
- With ≥ one (1) recalcitrant common, mosaic, palmar, plantar, or periungual wart/s
- Consent given
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Recalcitrant Cutaneous Warts
- Being tested
- Zinc gluconate, Corn starch pill
- Keywords
- Recalcitrant cutaneous warts, verruca
- Medical subject headings
- Warts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zinc gluconateDietary supplement
Corn starch pillDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Corn starch pill | Placebo comparator | Two (2) corn starch pills will be taken three (3) times a day for 60 days. Receives: 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. Receives: Dietary Supplement: Zinc gluconate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy based on the resolution rate (i.e. the percentage of baseline warts that resolve completely) on Days 30 and 60
Measured: 60 days
Secondary outcomes (3)
Types of adverse events
Types and severity of adverse events will be noted on Day 30 (+5 days) and Day 60 (+5 days) by the primary investigator by verbally asking the subjects and by physically examining them
Measured: 60 days
Severity of adverse events
Types and severity of adverse events will be noted on Day 30 (+5 days) and Day 60 (+5 days) by the primary investigator by verbally asking the subjects and by physically examining them. Severity will be based on the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events by the National Institute Of Allergy And Infectious Diseases. For abnormalities not found in the DAIDS Toxicity Tables, the following scale will be used to estimate grade:
- Grade 1, Mild: No limitation in activity; no medical intervention/therapy required
- Grade 2, Moderate: Mild to moderate limitation in activity; no or minimal medical intervention required
- Grade 3, Severe: Marked limitation in activity; medical intervention required; hospitalization possible
- Grade 4, Life-Threatening: Extreme limitation in activity; significant medical intervention required; hospitalization or hospice care probable
Measured: 60 days
Recurrence
The recurrence rate in patients who achieve complete response to zinc will be assessed at Day 120 or two months after discontinuation of zinc intake.
Measured: 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2013 (estimated)
- Study startJan 2013
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recalcitrant Cutaneous WartsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philippine Dermatological Society
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Rochelle L. Castillo, Philippine Dermatological Society
- Investigators
- Rochelle L. Castillo, M.D., Principal investigator, Philippine General Hospital Section of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01783353
- Sponsor's protocol ID
- PDS_PGH_2013_001
- Status last verified
- Nov 2013
- First submitted
- 30 Jan 2013
- Last updated
- 14 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Zinc Gluconate as Treatment for Recalcitrant Cutaneous Warts: A Randomized, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT01783353
- Acronym / sponsor ID
- PDS_PGH_2013_001
- Conditions
- Recalcitrant Cutaneous Warts
- Keywords
- Recalcitrant cutaneous warts, verruca
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Philippine Dermatological SocietyResearch network
- Study start
- Jan 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 4 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Corn starch pill | Placebo comparator | Dietary Supplement: Corn starch pillTwo (2) corn starch pills will be taken three (3) times a day for 60 days. |
| Zinc gluconate | Experimental | Dietary Supplement: Zinc gluconateTwo (2) zinc gluconate 50 mg capsules will be taken three (3) times a day for 60 days. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or non-pregnant female
- Age 19 years and older
- With ≥ one (1) recalcitrant common, mosaic, palmar, plantar, or periungual wart/s
- Consent given
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zinc gluconate | Dietary supplement | Zinc gluconate |
| Corn starch pill | Dietary supplement | Corn starch pill |
Primary outcome
Efficacy based on the resolution rate (i.e. the percentage of baseline warts that resolve completely) on Days 30 and 60
Time frame: 60 days
3 secondary outcomes
Types of adverse events
Time frame: 60 days
Severity of adverse events
Time frame: 60 days
Recurrence
Time frame: 120 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rochelle L. Castillo, M.D. principal investigator
Philippine General Hospital Section of Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Zinc gluconate and Corn starch pill in people with Recalcitrant Cutaneous Warts, run by Philippine Dermatological Society at 1 site in Philippines.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy based on the resolution rate (i.e. the percentage of baseline warts that resolve completely) on Days 30 and 60 (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2013.