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

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ClinicalTrials.gov Identifier: NCT02622568
Recruitment Status : Completed
First Posted : December 4, 2015
Results First Posted : September 8, 2017
Last Update Posted : September 8, 2017
Sponsor:
Information provided by (Responsible Party):
Nnenna Agim, University of Texas Southwestern Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Verruca, Warts
Interventions Drug: Veregen only
Procedure: Cryotherapy and Veregen
Enrollment 28
Recruitment Details Pediatric Dermatology Medical Clinic
Pre-assignment Details  
Arm/Group Title Cryotherapy + Veregen Veregen Only
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 14 14
Completed 9 9
Not Completed 5 5
Reason Not Completed
Lost to Follow-up             5             5
Arm/Group Title Cryotherapy + Veregen Veregen Only Total
Hide Arm/Group Description

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

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

Total of all reporting groups
Overall Number of Baseline Participants 14 14 28
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 14 participants 28 participants
<=18 years
14
 100.0%
14
 100.0%
28
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 14 participants 28 participants
9.1  (3.14) 10.1  (2.47) 9.6  (2.79)
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 9 participants 18 participants
Female
3
  33.3%
5
  55.6%
8
  44.4%
Male
6
  66.7%
4
  44.4%
10
  55.6%
[1]
Measure Analysis Population Description: Analysis limited to participants that completed the study
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants 14 participants 28 participants
14 14 28
Diameter of verrucae at presentation   [1] 
Mean (Standard Deviation)
Unit of measure:  Mm
Number Analyzed 9 participants 9 participants 18 participants
6.444  (1.9437) 6.222  (1.922) 6.3  (1.88)
[1]
Measure Analysis Population Description: Only participants completing study are included in analysis.
1.Primary Outcome
Title Size of Verrucae (Warts)
Hide Description Diameter of verrucae (warts) at week 12
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants completing study are included in analysis.
Arm/Group Title Cryotherapy + Veregen Veregen Only
Hide Arm/Group Description:

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 following cryotherapy

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

Overall Number of Participants Analyzed 9 9
Mean (Standard Deviation)
Unit of Measure: millimeters
2.333  (3.3541) 3.889  (3.9826)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cryotherapy + Veregen, Veregen Only
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments Veregen alone has efficacy compared to Veregen + cryotherapy
Statistical Test of Hypothesis P-Value 0.383
Comments Comparison at week 12
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.556
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cryotherapy + Veregen, Veregen Only
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments Comparison at week 0
Statistical Test of Hypothesis P-Value 0.81
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.222
Estimation Comments [Not Specified]
Time Frame 12 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cryotherapy + Veregen Veregen Only
Hide Arm/Group Description

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

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

All-Cause Mortality
Cryotherapy + Veregen Veregen Only
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)      0/14 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Cryotherapy + Veregen Veregen Only
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/14 (0.00%)      0/14 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
Cryotherapy + Veregen Veregen Only
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/14 (7.14%)      1/14 (7.14%)    
Skin and subcutaneous tissue disorders     
Minor irritation * [1]  1/14 (7.14%)  1 1/14 (7.14%)  1
*
Indicates events were collected by non-systematic assessment
[1]
transient itching and redness
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).
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Nnenna Agim
Organization: University of Texas Southwestern
Phone: 2144561631
EMail: Nnenna.Agim@childrens.com
Layout table for additonal information
Responsible Party: Nnenna Agim, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02622568     History of Changes
Other Study ID Numbers: 092014-012
First Submitted: December 2, 2015
First Posted: December 4, 2015
Results First Submitted: May 16, 2017
Results First Posted: September 8, 2017
Last Update Posted: September 8, 2017