Phase 4 N=28 Randomized Treatment

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

Verruca, Warts

Bottom Line

View on ClinicalTrials.gov: NCT02622568 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2017

Primary outcome: Primary: Size of Verrucae (Warts) — 2.333; 3.889 millimeters — p=0.383

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Veregen only (Drug); Cryotherapy and Veregen (Procedure)
Age: Pediatric · 6+ yrs
Sex: All
Sponsor: University of Texas Southwestern Medical Center
Primary completion: Jun 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Size of Verrucae (Warts)	2.333; 3.889	0.383

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02622568). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.