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NCT00116662 Clinical Trial

An up to Twelve Week Safety and Efficacy Study With a Topical Gel to Treat Common Warts in Pediatric Subjects

Warts Clinical Trial

Official title:
A Single-Blind, Dose-Escalating Study to Assess Efficacy and Safety of Resiquimod Gel Applied 3 Times Per Week for up to 12 Weeks for the Treatment of Common Warts in Pediatric Subjects

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00116662
Other study ID # 1534-RESI
Secondary ID
Status Completed
Phase Phase 2
First received June 30, 2005
Last updated February 16, 2007
Start date March 2005

Study information
Verified date November 2006
Source Graceway Pharmaceuticals, LLC
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The primary purpose of this study is to evaluate the effectiveness in pediatric subjects of three different strengths of resiquimod gel applied to common wart(s) three times a week for up to twelve weeks.

A second purpose is to evaluate the safety of the drug.

Recruitment information / eligibility
Status Completed
Enrollment 84
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 3 Years to 11 Years
Eligibility Inclusion Criteria:

- Diagnosis of common wart(s)

- Ages between 3 to 11

Exclusion Criteria:

- Other types of wart(s), ie. plantar

- Currently participating in another clinical study

- Chronic viral hepatitis B or C

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Resiquimod

Locations
Country Name City State
United States Massachusetts Boston Massachusetts
United States Illinois Buffalo Grove Illinois
United States Vermont Burlington Vermont
United States Arkansas Fayetteville Arkansas
United States Indiana Lafayette Indiana
United States Utah Layton Utah
United States Arkansas Little Rock Arkansas
United States Georgia Newnan Georgia
United States Missouri St. Louis Missouri
United States Kansas Wichita Kansas

Sponsors (1)
Lead Sponsor Collaborator
Graceway Pharmaceuticals, LLC

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Clearance of treated common wart(s)
Secondary Partial clearance of treated common wart(s)
Secondary Wart recurrence
See also
  Status Clinical Trial Phase
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Withdrawn NCT00546611 - The Purpose of This Study is to Determine Whether Topical Application of PEP005 is Safe for the Treatment of Common Wart(s) Phase 1
Completed NCT00117871 - Study With a Topical Gel to Treat Common Warts in Adults Phase 2
Completed NCT04278573 - Intralesional Vitamin D Injection for Treatment of Common Warts Phase 2
Completed NCT02231879 - Plerixafor Versus G-CSF in the Treatment of People With WHIM Syndrome Phase 2/Phase 3
Completed NCT06309420 - Clinical Trial to Evaluate Efficacy and Safety of a Cryogenic Medical Device for Treatment of Common and Plantar Warts N/A
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Completed NCT04781244 - Cost-effectiveness of EndWarts® FREEZE - an Alternative Home Cryotherapy Device for Wart Treatment N/A
Completed NCT01101750 - Does the HPV Vaccine Cause the Same Response in Adolescent Kidney and Liver Transplant Patients as in Healthy Controls? Phase 4
Completed NCT03487549 - Cantharidin and Occlusion in Verruca Epithelium Phase 2
Recruiting NCT05625633 - Human Papillomavirus (HPV) Vaccination vs. Placebo for the Treatment of Refractory Cutaneous Warts Phase 2/Phase 3
Completed NCT02393417 - Safety and Efficacy of Varying Regimens of CANDIN for Treatment of Common Warts (Verruca Vulgaris) Phase 2
Completed NCT01808443 - Efficacy of Laser Versus Cryotherapy in the Treatment of Warts N/A
Completed NCT00116675 - Four Week Safety and Efficacy Study With a Topical Gel to Treat Common Warts in Pediatric Subjects Phase 2
Completed NCT00114920 - Twelve Week Safety and Efficacy Study With a Topical Gel to Treat Common Warts in Adults Phase 2