Verruca, Warts
Conditions
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.
Interventions
DRUGVeregen only
Topical application of Veregen 15% ointment on affected areas twice daily
PROCEDURECryotherapy and Veregen
Cryotherapy followed by topical application of Veregen 15% ointment on affected areas twice daily
Sponsors
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 16 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Size of Verrucae (Warts) | 12 weeks | Diameter of verrucae (warts) at week 12 |
Countries
United States
Participant flow
Recruitment details
Pediatric Dermatology Medical Clinic
Participants by arm
| Arm | Count |
|---|---|
| Cryotherapy + 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. Veregen ™ 15% ointment will be prescribed and initiated immediately following the day of first clinic visit. Veregen ™ 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. The first day of treatment will begin on the day of first clinic visit (0 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 or Sinecatechins + cryotherapy | 14 |
| Veregen Only Veregen ™ 15% ointment will be prescribed and initiated immediately following the day of first clinic visit. Veregen ™ 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. The first day of treatment will begin on the day of first clinic visit (0 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 or Sinecatechins | 14 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 5 |
Baseline characteristics
| Characteristic | Cryotherapy + Veregen | Veregen Only | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 14 Participants | 14 Participants | 28 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 9.1 years STANDARD_DEVIATION 3.14 | 10.1 years STANDARD_DEVIATION 2.47 | 9.6 years STANDARD_DEVIATION 2.79 |
| Diameter of verrucae at presentation | 6.444 mm STANDARD_DEVIATION 1.9437 | 6.222 mm STANDARD_DEVIATION 1.922 | 6.3 mm STANDARD_DEVIATION 1.88 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 14 participants | 14 participants | 28 participants |
| Sex: Female, Male Female | 3 Participants | 5 Participants | 8 Participants |
| Sex: Female, Male Male | 6 Participants | 4 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 14 |
| other Total, other adverse events | 1 / 14 | 1 / 14 |
| serious Total, serious adverse events | 0 / 14 | 0 / 14 |
Outcome results
Primary
Size of Verrucae (Warts)
Diameter of verrucae (warts) at week 12
Time frame: 12 weeks
Population: Only participants completing study are included in analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cryotherapy + Veregen | Size of Verrucae (Warts) | 2.333 millimeters | Standard Deviation 3.3541 |
| Veregen Only | Size of Verrucae (Warts) | 3.889 millimeters | Standard Deviation 3.9826 |
p-value: 0.383t-test, 2 sided
p-value: 0.81t-test, 2 sided