NCT03625960

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2006

Shorter than P25 for phase_4

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

June 15, 2006

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2007

Completed
11.1 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 10, 2018

Completed
Last Updated

August 10, 2018

Status Verified

August 1, 2018

Enrollment Period

1 year

First QC Date

August 2, 2018

Last Update Submit

August 7, 2018

Conditions

Wart, Genital

Keywords

wartstrichloroacetic acid

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    2 weeks from starting therapy

  • Presence of scarring or skin discoloration

    2 weeks from starting therapy

Study Arms (2)

Cantharidine group

EXPERIMENTAL

Application of cantharidine to perenial warts

Drug: Cantharidin

trichloroacetic acid group

ACTIVE COMPARATOR

application of trichloroacetic acid to perenial warts

Drug: Trichloroacetic Acid

Interventions

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.

Cantharidine group
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.

trichloroacetic acid group

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThis is a study on perenial genital warts, near the vulvovaginal area. Only women have vulvovaginas.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

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

    PMID: 22479897BACKGROUND

  • 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.

    PMID: 26239450RESULT

  • 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.

    PMID: 13519856RESULT

  • 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.

    PMID: 24643186RESULT

MeSH Terms

Conditions

Condylomata AcuminataWarts

Interventions

CantharidinTrichloroacetic Acid

Condition Hierarchy (Ancestors)

Papillomavirus InfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesSkin Diseases, ViralTumor Virus InfectionsGenital DiseasesUrogenital DiseasesSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsChloroacetatesAcetatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydrocarbons, ChlorinatedHydrocarbons, HalogenatedHydrocarbons

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Patients will be randomized to receive treatment with trichloroacetic acid or cantharidine.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients will be randomized to receive either trichloroacetic acid or cantharidine treatment.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Clinical Educator

Study Record Dates

First Submitted

August 2, 2018

First Posted

August 10, 2018

Study Start

June 15, 2006

Primary Completion

June 15, 2007

Study Completion

July 15, 2007

Last Updated

August 10, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share