Verruca, Warts Clinical Trial
Official title:
Investigating Veregen ™ 15% Ointment Treatment For Non-facial Verrucae in Pediatric Patients: A Pilot Study
| NCT number | NCT02622568 |
| Other study ID # | 092014-012 |
| Secondary ID | |
| Status | Recruiting |
| Phase | Phase 4 |
| First received | December 2, 2015 |
| Last updated | December 3, 2015 |
| Start date | July 2015 |
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.
| Status | Recruiting |
| Enrollment | 30 |
| Est. completion date | |
| Est. primary completion date | July 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 6 Years to 16 Years |
| Eligibility |
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 |
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | UTSW Department of Dermatology | Dallas | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| University of Texas Southwestern Medical Center |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Wart size reduction | 12 weeks | No |