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

NCT ID: NCT02622568

Last Updated: 2017-09-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2016-06-30

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.

Conditions

Verruca, Warts

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Veregen only

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

Cryotherapy and Veregen

Intervention Type: PROCEDURE

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

Interventions

Veregen only

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

Intervention Type: DRUG

Cryotherapy and Veregen

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Nnenna Agim

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

UTSW Department of Dermatology

Dallas, Texas, United States

Countries

United States

Other Identifiers

092014-012

Identifier Type: -

Identifier Source: org_study_id