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

NCT02622568 | Completed Phase 4 Results

• 1 other identifier: 092014-012
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Verruca, Warts

Outcome Measures

Primary Outcomes (1)

• Size of Verrucae (Warts)

  Diameter of verrucae (warts) at week 12

  12 weeks

Study Arms (2)

Cryotherapy and Veregen

ACTIVE COMPARATOR

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 only

EXPERIMENTAL

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

Interventions

Veregen only DRUG

Topical application of Veregen 15% ointment on affected areas twice daily

Veregen only

Cryotherapy and Veregen PROCEDURE

Cryotherapy followed by topical application of Veregen 15% ointment on affected areas twice daily

Cryotherapy and Veregen

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UTSW Department of Dermatology

Dallas, Texas, 75390-9069, United States

Location

MeSH Terms

Conditions

Warts

Interventions

Cryotherapy; green tea extract polyphenone E

Condition Hierarchy (Ancestors)

Papillomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Tumor Virus Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Limitations and Caveats

Attrition rate acceptable for pilot study. Some participants were lost at the first measurement follow-up, others at the second (6 and 12 weeks respectively).

Results Point of Contact

• Title: Dr. Nnenna Agim
• Organization: University of Texas Southwestern

Nnenna.Agim@childrens.com

2144561631

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigating Veregen ™ 15% Ointment Treatment For Non-facial Verrucae in Pediatric Patients: A Pilot Study

Study Record Dates

• First Submitted: December 2, 2015
• First Posted: December 4, 2015
• Study Start: July 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: September 8, 2017
• Results First Posted: September 8, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)