Verruca VulgarisNCT01084824
A Trial Examining the Treatment of Common Warts With Combination Liquid Nitrogen (LN2) and Cantharidin
A study testing Liquid nitrogen and cantharidin in people with Verruca Vulgaris, run by North Idaho Dermatology at 1 site in United States.
Trial summary
The purpose of the study was to see if liquid nitrogen, a commonly used treatment for warts, is more effective if it is used alone, or if it is more effective if combined with cantharidin, a topical treatment also commonly used for warts (verruca vulgaris). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Verruca Vulgaris
- What is being tested?
- Liquid nitrogen and cantharidin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Sep 2008
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- common warts on non-genital, non-facial skin
- otherwise healthy
- between 18-65 and able to give informed consent
- capable of tolerating treatment
Who cannot join
- Ill-health
- Poor tolerance or sensitivity to treatments in study
- <18 years old; >65 years old
- verruca plana or condyloma acuminata
- immunosuppression or immune dysfunction
- significant peripheral vascular disease
Show all 9Show fewer
- significant sensitivity to cold
- epidermodysplasia verruciformis
- mosaiform warts or periungual warts
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Clinical Trial Examining the Efficacy of Treatment of Cutaneous Verruca Vulgaris in Adult Patients With Combined Liquid Nitrogen Cryotherapy and Topically Applied Cantharidin
The purpose of the study was to see if liquid nitrogen, a commonly used treatment for warts, is more effective if it is used alone, or if it is more effective if combined with cantharidin, a topical treatment also commonly used for warts (verruca vulgaris).
- Conditions
- Verruca Vulgaris
- Being tested
- Liquid nitrogen and cantharidin, Liquid nitrogen and topical placebo
- Keywords
- Warts, Verruca vulgaris, Liquid Nitrogen, Cantharidin, combination treatment
- Medical subject headings
- Warts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liquid nitrogen and cantharidinDrug
Liquid nitrogen applied to wart(s), then cantharidin 1% topical applied afterward.
Liquid nitrogen and topical placeboDrug
Liquid nitrogen applied to wart(s), then placebo vehicle applied thereafter.
| Study group | Role | What they receive |
|---|---|---|
| Liquid nitrogen and canthardin | Active comparator | Liquid nitrogen applied to wart(s), then cantharidin 1% topical applied afterwards. Receives: Drug: Liquid nitrogen and cantharidin |
| Liquid nitrogen and placebo | Placebo comparator | Liquid nitrogen applied to wart(s) then placebo vehicle afterwards. Receives: Drug: Liquid nitrogen and topical placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of common warts cleared
Percentage of treated warts cleared with treatment, as measured with dermatoscopic examination, after 12 weeks.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2010 (estimated)
- Study startJun 2007
- Primary completionJun 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Verruca VulgarisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Idaho Dermatology
- Sponsor type
- University, hospital or other
- Investigators
- Richard A Flygare, PhD, Principal investigator, TUI University; North Idaho Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01084824
- Sponsor's protocol ID
- NID-001
- Status last verified
- Mar 2010
- First submitted
- 10 Mar 2010
- Last updated
- 11 Mar 2010
- Results posted
- No
Publications
Berth-Jones J, Bourke J, Eglitis H, Harper C, Kirk P, Pavord S, Rajapakse R, Weston P, Wiggins T, Hutchinson PE. Value of a second freeze-thaw cycle in cryotherapy of common warts. Br J Dermatol. 1994 Dec;131(6):883-6. doi: 10.1111/j.1365-2133.1994.tb08594.x.
PubMed 7857844Guidelines of care for cryosurgery. American Academy of Dermatology Committee on Guidelines of Care. J Am Acad Dermatol. 1994 Oct;31(4):648-53. No abstract available.
PubMed 8089292Moed L, Shwayder TA, Chang MW. Cantharidin revisited: a blistering defense of an ancient medicine. Arch Dermatol. 2001 Oct;137(10):1357-60. doi: 10.1001/archderm.137.10.1357.
PubMed 11594862
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial Examining the Efficacy of Treatment of Cutaneous Verruca Vulgaris in Adult Patients With Combined Liquid Nitrogen Cryotherapy and Topically Applied Cantharidin
- ClinicalTrials.gov ID
- NCT01084824
- Acronym / sponsor ID
- NID-001
- Conditions
- Verruca Vulgaris
- Keywords
- Warts, Verruca vulgaris, Liquid Nitrogen, Cantharidin, combination treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- North Idaho DermatologyUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 11 Mar 2010 (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.
The purpose of the study was to see if liquid nitrogen, a commonly used treatment for warts, is more effective if it is used alone, or if it is more effective if combined with cantharidin, a topical treatment also commonly used for warts (verruca vulgaris).
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 |
|---|---|---|
| Liquid nitrogen and canthardin | Active comparator | Drug: Liquid nitrogen and cantharidinLiquid nitrogen applied to wart(s), then cantharidin 1% topical applied afterwards. |
| Liquid nitrogen and placebo | Placebo comparator | Drug: Liquid nitrogen and topical placeboLiquid nitrogen applied to wart(s) then placebo vehicle afterwards. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- common warts on non-genital, non-facial skin
- otherwise healthy
- between 18-65 and able to give informed consent
- capable of tolerating treatment
Key exclusion criteria (9 listed)
- Ill-health
- Poor tolerance or sensitivity to treatments in study
- <18 years old; >65 years old
- verruca plana or condyloma acuminata
- immunosuppression or immune dysfunction
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 |
|---|---|---|
| Liquid nitrogen and cantharidinLiquid nitrogen applied to wart(s), then cantharidin 1% topical applied afterward. | Drug | Liquid nitrogen and canthardin |
| Liquid nitrogen and topical placeboLiquid nitrogen applied to wart(s), then placebo vehicle applied thereafter. | Drug | Liquid nitrogen and placebo |
Primary outcome
Percentage of common warts cleared
Time frame: 12 weeks
Percentage of treated warts cleared with treatment, as measured with dermatoscopic examination, after 12 weeks.
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 11 Mar 2010.
- Background: PubMed 7857844Berth-Jones J, Bourke J, Eglitis H, Harper C, Kirk P, Pavord S, Rajapakse R, Weston P, Wiggins T, Hutchinson PE. Value of a second freeze-thaw cycle in cryotherapy of common warts. Br J Dermatol. 1994 Dec;131(6):883-6. doi: 10.1111/j.1365-2133.1994.tb08594.x.
- Background: PubMed 8089292Guidelines of care for cryosurgery. American Academy of Dermatology Committee on Guidelines of Care. J Am Acad Dermatol. 1994 Oct;31(4):648-53. No abstract available.
- Background: PubMed 11594862Moed L, Shwayder TA, Chang MW. Cantharidin revisited: a blistering defense of an ancient medicine. Arch Dermatol. 2001 Oct;137(10):1357-60. doi: 10.1001/archderm.137.10.1357.
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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.
Richard A Flygare, PhD principal investigator
TUI University; North Idaho Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liquid nitrogen and cantharidin in people with Verruca Vulgaris, run by North Idaho Dermatology at 1 site in United States.
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 9 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 11 Mar 2010. 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 United States. 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.
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?
Percentage of common warts cleared (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01084824, which also lists 3 linked publications.
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 11 Mar 2010.