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

Phase 4

Completed

• Conditions: Verruca, Warts
• Interventions: Procedure: Cryotherapy and Veregen; Drug: Veregen only

• Registration Number: NCT02622568
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief Summary

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-12-02
• Study First Submitted QC: 2015-12-03
• Study First Posted: 2015-12-04
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Results First Submitted: 2017-05-16
• Status Verified: 2017-08
• Results First Submitted QC: 2017-08-07
• Last Update Submitted: 2017-08-07
• Results First Posted: 2017-09-08
• Last Update Posted: 2017-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cryotherapy and Veregen	Cryotherapy and Veregen	Cryotherapy will be performed on the day of first clinic visit according to current standard of care in Children's Medical Center pediatric outpatient dermatology clinic, which consists of two freeze/thaw cycles for maximum of 10 seconds each. Sinecathecins 15% ointment will be prescribed and initiated immediately following the day of first clinic visit. Sinecathecins 15% ointment will be applied to verrucous lesions twice daily. Follow-up clinical visits will be required at 0 weeks, 6 weeks, and 12 weeks. Clinical photos will be taken at each visit. Verrucae will be measured at each visit using a standard ruler. Outcome measures will be numerical reduction in diameter of verruca.
Veregen only	Veregen only	Veregen ™or sinecathecins 15% ointment will be prescribed and initiated immediately following the day of first clinic visit. Veregen ™ or sinecathecins 15% ointment will be applied to verrucous lesions twice daily per current Children's Medical Center protocol. Follow-up clinical visits will be required at 0 weeks, 6 weeks, and 12 weeks. Clinical photos will be taken at each visit. Verrucae will be measured at each visit using a standard ruler. Outcome measures will be numerical reduction in diameter of verruca.

Primary Outcome Measures

Name	Time	Method
Size of Verrucae (Warts)	12 weeks	Diameter of verrucae (warts) at week 12

Trial Locations

Locations (1)

UTSW Department of Dermatology; 🇺🇸 Dallas, Texas, United States