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Completed

NCT Number: NCT02622568

Investigating Veregen ™ 15% Ointment Treatment For Non-facial Verrucae in Pediatric Patients: A Pilot Study

The purpose of this study is to investigate topical treatment with Veregen™ 15% ointment as a single therapeutic agent and compare it to combination therapy with Veregen ™ 15% ointment and a single destructive treatment by cryotherapy for non-facial verruca vulgaris in the pediatric population. This novel treatment modality may be useful in the pediatric dermatology community offering a less invasive, painless option for treatment of non-facial verruca vulgaris.

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Key information

Age range

6 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UTSW Department of Dermatology

Dallas, Texas, 75390-9069, United States

About this study

The purpose of this study is to investigate topical treatment with Veregen™ 15% ointment as a single therapeutic agent and compare it to combination therapy with Veregen ™ 15% ointment and a single destructive treatment by cryotherapy for non-facial verruca vulgaris in the pediatric population. The investigators will compare the single and combination treatment modalities over identical time points in patients with non-facial verruca vulgaris. One of the current options for care for non-facial verruca includes cryotherapy, which is a painful and destructive method performed in the pediatric dermatology clinic. This study aims to establish the safety, non-invasivenature, efficiency, and efficacy of Veregen ™ 15% ointment as monotherapyfor non-facial verruca vulgaris in the pediatric population. The investigators hypothesize that Veregen ™ 15% ointment monotherapy will non-invasively treat non-facial verruca vulgaris with similar efficacy as combination therapy with a single cryotherapy treatment followed by topical application of Veregen ™ ointment. This novel treatment modality will be useful in the pediatric dermatology community offering a less invasive, painless option for treatment of non-facial verruca vulgaris.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female of any ethnic background
  • Age between 6 years old and 16 years old
  • A clinical diagnosis of non-facial verruca vulgaris
  • Able to adhere to study visit schedule, Veregen ™ treatment requirements, and baseline cryotherapy treatment in half of patients
  • Verruca size greater than 5 mm

Exclusion criteria

  • Medically unstable patients
  • Patients with immunosuppression
  • Families who decline participation
  • Verruca may not have been treated in preceding 4 weeks prior to enrollment
  • Verruca may not be located on the face or genitalia
  • Verruca size less than 5 mm

Treatment and study plan

Veregen only

Drug

Topical application of Veregen 15% ointment on affected areas twice daily

Cryotherapy and Veregen

Procedure

Cryotherapy followed by topical application of Veregen 15% ointment on affected areas twice daily

Primary outcomes

  1. Size of Verrucae (Warts)

    Time frame: 12 weeks

    Diameter of verrucae (warts) at week 12

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 4, 2015
Registry last updated
Sep 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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