Expired Study
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Dallas, Texas 75390


Purpose:

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.


Study 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. 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.


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


Study is Available At:


Original ID:

092014-012


NCT ID:

NCT02622568


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 4


Genders:

N/A


Minimum Age:

6 Years


Maximum Age:

16 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Texas Southwestern Medical Center


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

28


Enrollment Type:

Actual


Study Dates

Start Date:July 2015
Completion Date:June 2016
Completion Type:Actual
Primary Completion Date:June 2016
Primary Completion Type:Actual
Verification Date:August 2017
Last Changed Date:August 7, 2017
First Received Date:December 2, 2015
First Results Date:May 16, 2017

Study Outcomes

Outcome Type:Primary Outcome
Measure:Size of Verrucae (Warts)
Time Frame:12 weeks
Safety Issues:False
Description:Diameter of verrucae (warts) at week 12

Study Interventions

Intervention Type:Drug
Name:Veregen only
Description:Topical application of Veregen 15% ointment on affected areas twice daily
Arm Name:Veregen only
Intervention Type:Procedure
Name:Cryotherapy and Veregen
Description:Cryotherapy followed by topical application of Veregen 15% ointment on affected areas twice daily
Arm Name:Cryotherapy and Veregen

Study Arms

Study Arm Type:Experimental
Arm Name:Veregen only
Description: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 dia
Study Arm Type:Active Comparator
Arm Name:Cryotherapy and Veregen
Description: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, an

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Texas Southwestern Medical Center

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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