Cantharone for the Treatment of Perenial Warts

NCT ID: NCT03625960

Last Updated: 2018-08-10

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-15

Study Completion Date

2007-07-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Comparison of trichloroacetic acid versus cantharidine for the treatment of perenial warts.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

1. Determine if cantharone is more effective than trichloroacetic acid (TCA) for removal of warts
2. Compare pain levels (pain during application) for each method
3. Compare patient satisfaction for each method
4. Compare scar formation and cosmesis for each method

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Wart, Genital

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients will be randomized to receive either trichloroacetic acid or cantharidine treatment.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators
Patients will be randomized to receive treatment with trichloroacetic acid or cantharidine.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cantharidine group

Application of cantharidine to perenial warts

Group Type EXPERIMENTAL

Cantharidin

Intervention Type DRUG

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 acid group

application of trichloroacetic acid to perenial warts

Group Type ACTIVE_COMPARATOR

Trichloroacetic Acid

Intervention Type DRUG

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cantharidin

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.

Intervention Type DRUG

Trichloroacetic Acid

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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Warts on the perenial area
* Less than 4mm across.

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of California, San Francisco

OTHER

Sponsor Role collaborator

St Vincent's Hospital

OTHER

Sponsor Role collaborator

Wayne State University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Maurice-Andre Recanati

Assistant Professor, Clinical Educator

Responsibility Role PRINCIPAL_INVESTIGATOR

References

Explore related publications, articles, or registry entries linked to this study.

Bakardzhiev I, Kovachev E. [Comparative assessment of the methods of treatment of Condylomata acuminata]. Akush Ginekol (Sofiia). 2011;50(4):45-51. Bulgarian.

Reference Type BACKGROUND
PMID: 22479897 (View on PubMed)

Kollipara 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.

Reference Type RESULT
PMID: 26239450 (View on PubMed)

EPSTEIN 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.

Reference Type RESULT
PMID: 13519856 (View on PubMed)

Ramirez-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.

Reference Type RESULT
PMID: 24643186 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

01551

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Candin for the Treatment of Common Warts
NCT05889845 COMPLETED PHASE3
ALC-919 For The Treatment Of Common Warts
NCT02483455 COMPLETED PHASE2