Wart, GenitalPhase 4NCT03625960
Cantharone for the Treatment of Perenial Warts
A Phase 4 study testing Cantharidin and Trichloroacetic Acid in people with Wart, Genital, run by Wayne State University.
Trial summary
Comparison of trichloroacetic acid versus cantharidine for the treatment of perenial warts. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Wart, Genital
- What is being tested?
- Cantharidin and Trichloroacetic Acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2006to 15 Jul 2007
- Phase
- Phase 4
- 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 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Warts on the perenial area
- Less than 4mm across.
Who cannot join
- Pregnancy
- Less than 18 years old
- Lesions larger than 4 millimeters across
- Unclear diagnosis
- Internal warts
- Diabetes
- HIV
- Warts within 2 cm of mucosal areas
About this study
Official title: Trichloroacetic Acid Versus Cantharone for the Treatment of Perenial Warts
Comparison of trichloroacetic acid versus cantharidine for the treatment of perenial warts.
Read the detailed description
Warts are one of the most common sexually transmitted diseases. They are caused by the human papilloma virus (HPV) that causes cervical cancer. Warts can grow, obstruct labor, and spread. Patients presenting to the obgyn clinic with perenial warts were randomized to treatment with trichloroacetic acid (one of the many types of treatments) or to the treatment with cantharidine group. Cantharidine is a vesicant extracted from beetle bugs which painlessly causes a small blister to form and cures the patient from the HPV infection causing the wart . We compared cosmesis, scar formation, pain and number of treatments (visits) as well as effectiveness in both groups.
Objectives
- Determine if cantharone is more effective than trichloroacetic acid (TCA) for removal of warts
- Compare pain levels (pain during application) for each method
- Compare patient satisfaction for each method
- Compare scar formation and cosmesis for each method
- Conditions
- Wart, Genital
- Being tested
- Cantharidin, Trichloroacetic Acid
- Keywords
- warts, trichloroacetic acid
- Medical subject headings
- Condylomata Acuminata, Warts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CantharidinDrug
A thin film of cantharidin is applied to the surface of the wart and to 1 millimeter area surrounding the wart. After the film dries, it is covered with an occlusive dressing for 24 hours. The patient removes the area the next day and thoroughly washes the area with soap and water. Patients return to clinic a week later.
Trichloroacetic AcidDrug
Trichloroacetic acid is applied to the surface of the wart with a wooden applicator and after drying the area is washed with soap and water in an hour.
| Study group | Role | What they receive |
|---|---|---|
| Cantharidine group | Experimental | Application of cantharidine to perenial warts Receives: Drug: Cantharidin |
| trichloroacetic acid group | Active comparator | application of trichloroacetic acid to perenial warts Receives: Drug: Trichloroacetic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain on treatment
Comparison of pain when treatment is applied. The patient is asked on a scale of 0-5 (with 5 being extreme pain, 4 being severe pain, 3 being moderate, 2 being mild, 1 being slight and zero being no pain, how do you rate your pain.
Measured: at 30 minutes time point from application of treatment.
Secondary outcomes (2)
Assessment of a patient's likelihood of using this method again as measured on a survey question
A questionnaire given to the patient at the conclusion of the study and containing the question "on a scale from 1-5 (5 most likely) how likely are you to recommend this method to a friend or using it again yourself".
Measured: 2 weeks from starting therapy
Presence of scarring or skin discoloration
At the time of wart eradication, the treatment area is examined for healing. The clinician rates cosmesis on a scale from 0-5 with 5-skin grows back perfectly, 4-slight discoloration, 3-thickened skin, 1-slight scarring and 0-scarring.
Measured: 2 weeks from starting therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start15 Jun 2006
- Primary completion15 Jun 2007
- Study completion15 Jul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Wart, GenitalStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized to receive either trichloroacetic acid or cantharidine treatment.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco, St Vincent's Hospital
- Responsible party
- Principal investigator, Maurice-Andre Recanati, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03625960
- Sponsor's protocol ID
- 01551
- Status last verified
- Aug 2018
- First submitted
- 2 Aug 2018
- Last updated
- 10 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bakardzhiev I, Kovachev E. [Comparative assessment of the methods of treatment of Condylomata acuminata]. Akush Ginekol (Sofiia). 2011;50(4):45-51. Bulgarian.
PubMed 22479897Kollipara R, Ekhlassi E, Downing C, Guidry J, Lee M, Tyring SK. Advancements in Pharmacotherapy for Noncancerous Manifestations of HPV. J Clin Med. 2015 Apr 24;4(5):832-46. doi: 10.3390/jcm4050832.
PubMed 26239450EPSTEIN WL, KLIGMAN AM. Treatment of warts with cantharidin. AMA Arch Derm. 1958 May;77(5):508-11. doi: 10.1001/archderm.1958.01560050014003. No abstract available.
PubMed 13519856Ramirez-Fort MK, Au SC, Javed SA, Loo DS. Management of cutaneous human papillomavirus infection: pharmacotherapies. Curr Probl Dermatol. 2014;45:175-85. doi: 10.1159/000356069. Epub 2014 Mar 13.
PubMed 24643186
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trichloroacetic Acid Versus Cantharone for the Treatment of Perenial Warts
- ClinicalTrials.gov ID
- NCT03625960
- Acronym / sponsor ID
- 01551
- Conditions
- Wart, Genital
- Keywords
- warts, trichloroacetic acid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Collaborators
- University of California, San Francisco, St Vincent's Hospital
- Study start
- 15 Jun 2006 (actual)
- Primary completion
- 15 Jun 2007 (actual)
- Study completion
- 15 Jul 2007 (actual)
- First posted
- 10 Aug 2018 (actual)
- 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.
Comparison of trichloroacetic acid versus cantharidine for the treatment of perenial warts.
Detailed description
Warts are one of the most common sexually transmitted diseases. They are caused by the human papilloma virus (HPV) that causes cervical cancer. Warts can grow, obstruct labor, and spread. Patients presenting to the obgyn clinic with perenial warts were randomized to treatment with trichloroacetic acid (one of the many types of treatments) or to the treatment with cantharidine group. Cantharidine is a vesicant extracted from beetle bugs which painlessly causes a small blister to form and cures the patient from the HPV infection causing the wart . We compared cosmesis, scar formation, pain and number of treatments (visits) as well as effectiveness in both groups.
Objectives
- Determine if cantharone is more effective than trichloroacetic acid (TCA) for removal of warts
- Compare pain levels (pain during application) for each method
- Compare patient satisfaction for each method
- Compare scar formation and cosmesis for each method
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Patients will be randomized to receive either trichloroacetic acid or cantharidine treatment.
| Arm | Type | Receives |
|---|---|---|
| Cantharidine group | Experimental | Drug: CantharidinApplication of cantharidine to perenial warts |
| trichloroacetic acid group | Active comparator | Drug: Trichloroacetic Acidapplication of trichloroacetic acid to perenial warts |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Warts on the perenial area
- Less than 4mm across.
Key exclusion criteria (8 listed)
- Pregnancy
- Less than 18 years old
- Lesions larger than 4 millimeters across
- Unclear diagnosis
- Internal warts
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 |
|---|---|---|
| CantharidinA thin film of cantharidin is applied to the surface of the wart and to 1 millimeter area surrounding the wart. After the film dries, it is covered with an occlusive dressing for 24 hours. The patient removes the area the next day and thoroughly washes the area with soap and water. Patients return to clinic a week later. | Drug | Cantharidine group |
| Trichloroacetic AcidTrichloroacetic acid is applied to the surface of the wart with a wooden applicator and after drying the area is washed with soap and water in an hour. | Drug | trichloroacetic acid group |
Primary outcome
Pain on treatment
Time frame: at 30 minutes time point from application of treatment.
Comparison of pain when treatment is applied. The patient is asked on a scale of 0-5 (with 5 being extreme pain, 4 being severe pain, 3 being moderate, 2 being mild, 1 being slight and zero being no pain, how do you rate your pain.
2 secondary outcomes
Assessment of a patient's likelihood of using this method again as measured on a survey question
Time frame: 2 weeks from starting therapy
Presence of scarring or skin discoloration
Time frame: 2 weeks from starting therapy
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 10 Aug 2018.
- Background: PubMed 22479897Bakardzhiev I, Kovachev E. [Comparative assessment of the methods of treatment of Condylomata acuminata]. Akush Ginekol (Sofiia). 2011;50(4):45-51. Bulgarian.
- Results publication: PubMed 26239450Kollipara R, Ekhlassi E, Downing C, Guidry J, Lee M, Tyring SK. Advancements in Pharmacotherapy for Noncancerous Manifestations of HPV. J Clin Med. 2015 Apr 24;4(5):832-46. doi: 10.3390/jcm4050832.
- Results publication: PubMed 13519856EPSTEIN WL, KLIGMAN AM. Treatment of warts with cantharidin. AMA Arch Derm. 1958 May;77(5):508-11. doi: 10.1001/archderm.1958.01560050014003. No abstract available.
- Results publication: PubMed 24643186Ramirez-Fort MK, Au SC, Javed SA, Loo DS. Management of cutaneous human papillomavirus infection: pharmacotherapies. Curr Probl Dermatol. 2014;45:175-85. doi: 10.1159/000356069. Epub 2014 Mar 13.
- Individual participant dataSharing planned: No
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Warts
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cantharidin and Trichloroacetic Acid in people with Wart, Genital, run by Wayne State University.
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 2 inclusion and 8 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 10 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Pain on treatment (time frame: at 30 minutes time point from application of treatment.). 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 NCT03625960, which also lists 4 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 10 Aug 2018.