A Phase 4 interventional study of Veregen only and Cryotherapy and Veregen in Verruca, Warts, sponsored by University of Texas Southwestern Medical Center. Completed at 1 site in United States. Open to participants aged 6 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-08.
Sponsored by University of Texas Southwestern Medical Center · Phase 4, Interventional, and Treatment
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.
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.
180 studies on the registry are indexed under Warts; 28 are open to participants now.
This study's enrollment of 28 is below the median of 70 across 159 interventional studies indexed under Warts.
Browse Warts studies →University of Texas Southwestern Medical Center is the lead sponsor of 990 studies on the registry; 201 are open to participants now.
Of its 135 completed or terminated interventional studies of FDA-regulated products, 100 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Procedure: Cryotherapy and Veregen
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.
Drug: Veregen only
Topical application of Veregen 15% ointment on affected areas twice daily
Cryotherapy followed by topical application of Veregen 15% ointment on affected areas twice daily
Size of Verrucae (Warts)
Diameter of verrucae (warts) at week 12
Time frame: 12 weeks
Pediatric Dermatology Medical Clinic
| Milestone | Cryotherapy + Veregen | Veregen Only |
|---|---|---|
| Started | 14 | 14 |
| Completed | 9 | 9 |
| Not completed | 5 | 5 |
| Withdrew: Lost to follow-up | 5 | 5 |
Diameter of verrucae (warts) at week 12
| millimeters | Cryotherapy + Veregen | Veregen Only |
|---|---|---|
| Size of Verrucae (Warts) | 2.333 ± 3.3541 | 3.889 ± 3.9826 |
Collected over 12 weeks. Non-serious events are listed at a 4% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cryotherapy + Veregen | 0/14 (0%) | 0/14 (0%) | 1/14 (7.1%) |
| Veregen Only | 0/14 (0%) | 0/14 (0%) | 1/14 (7.1%) |
| Event | Cryotherapy + Veregen | Veregen Only |
|---|---|---|
| Minor irritationSkin and subcutaneous tissue disorders | 1/14 | 1/14 |
| Age, Categorical(Participants) | Cryotherapy + Veregen | Veregen Only | Total |
|---|---|---|---|
| <=18 years | 14 | 14 | 28 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Cryotherapy + Veregen | Veregen Only | Total |
|---|---|---|---|
| Mean | 9.1 ± 3.14 | 10.1 ± 2.47 | 9.6 ± 2.79 |
| Sex: Female, Male(Participants) | Cryotherapy + Veregen | Veregen Only | Total |
|---|---|---|---|
| Female | 3 | 5 | 8 |
| Male | 6 | 4 | 10 |
| Race and Ethnicity Not Collected(Participants) | Cryotherapy + Veregen | Veregen Only | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Cryotherapy + Veregen | Veregen Only | Total |
|---|---|---|---|
| United States | 14 | 14 | 28 |
| Diameter of verrucae at presentation(mm) | Cryotherapy + Veregen | Veregen Only | Total |
|---|---|---|---|
| Mean | 6.444 ± 1.9437 | 6.222 ± 1.922 | 6.3 ± 1.88 |
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Texas Southwestern Medical Center