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Trial record 25 of 126 for:    "Viral Infectious Disease" | "Ethanol"

Evaluation of the Effectiveness of an Alcohol Based Hand Gel for the Reduction of Warts on the Hands

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00973856
Recruitment Status : Completed
First Posted : September 9, 2009
Results First Posted : July 2, 2019
Last Update Posted : July 2, 2019
Sponsor:
Information provided by (Responsible Party):
Akron General Medical Center

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Papillomavirus Infections
Warts
Condylomata Acuminata
Epidermodysplasia Verruciformis
Interventions Other: PURELL VF481
Other: Placebo Solution
Enrollment 5
Recruitment Details  
Pre-assignment Details There were no pre-assignment details. Once consented, pts were enrolled into both study arms.
Arm/Group Title PURELL VF481 Left Hand/ Placebo Right Hand Placebo Solution Left Hand/ PURELL VF481 Right Hand
Hide Arm/Group Description

Warts are equally distributed between products so that an equal number of warts treated on each person. One (1) product will be assigned to each hand to minimize treatment confusion for the participants

PURELL VF481: One (1) pump of test product (approximately 1.5ml) is applied to a wooden applicator and gently rubbed into the wart, then covered with a latex free adhesive bandage (it is not necessary to wait until dry) each night before bed

Warts are equally distributed between products so that an equal number of warts treated on each person One (1) product will be assigned to each hand to minimize treatment confusion for the participants

One (1) pump of test product (approximately 1.5ml) is applied to a wooden applicator and gently rubbed into the wart, then covered with a latex free adhesive bandage (it is not necessary to wait until dry) each night before bed

Placebo Comparator: One (1) pump of product (approximately 1.5ml) is applied to a wooden applicator and gently rubbed into the wart, then covered with a latex free adhesive bandage (it is not necessary to wait until dry) each night before bed

Period Title: Overall Study
Number of participants Number of units (warts,not pts assigned to intervention) Number of participants Number of units (warts,not pts assigned to intervention)
Started 3 5 2 5
Completed 3 5 2 5
Not Completed 0 0 0 0
Arm/Group Title PURELL VF481 Left Hand/ Placebo Right Hand Placebo Solution Left Hand/ PURELL VF481 Right Hand Total
Hide Arm/Group Description

Warts are equally distributed between products so that an equal number of warts treated on each person. One (1) product will be assigned to each hand to minimize treatment confusion for the participants

PURELL VF481: One (1) pump of test product (approximately 1.5ml) is applied to a wooden applicator and gently rubbed into the wart, then covered with a latex free adhesive bandage (it is not necessary to wait until dry) each night before bed

Warts are equally distributed between products so that an equal number of warts treated on each person. One (1) product will be assigned to each hand to minimize treatment confusion for the participants

One (1) pump of test product (approximately 1.5ml) is applied to a wooden applicator and gently rubbed into the wart, then covered with a latex free adhesive bandage (it is not necessary to wait until dry) each night before bed

Placebo Comparator: One (1) pump of product (approximately 1.5ml) is applied to a wooden applicator and gently rubbed into the wart, then covered with a latex free adhesive bandage (it is not necessary to wait until dry) each night before bed

Total of all reporting groups
Overall Number of Baseline Participants 3 2 5
Overall Number of Units Analyzed
Type of Units Analyzed: Warts
5 5 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Count of Units
Unit of measure:  Warts
Number Analyzed 5 warts 5 warts 10 warts
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
5
 100.0%
5
 100.0%
10
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex/Gender, Customized  
Count of Units
Unit of measure:  Warts
Sex/Gender unspecified Number Analyzed 5 warts 5 warts 10 warts
5
 100.0%
5
 100.0%
10
 100.0%
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 5 warts 5 warts 10 warts
5 5 10
1.Primary Outcome
Title Difference in % Reduction in Wart Size Between Product A and Product B at Each Timepoint
Hide Description Data is not available due to study closure and data destruction
Time Frame Baseline, 4, 8, and 12 weeks, change at 12 weeks reported
Hide Outcome Measure Data
Hide Analysis Population Description
Data is not available due to study closure and data destruction
Arm/Group Title Purell VF481
Hide Arm/Group Description:
Active Ingredient: 70% ethanol
Overall Number of Participants Analyzed 0
Overall Number of Units Analyzed
Type of Units Analyzed: Wart reduction %
0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Change in Size of Warts Treated by Each Product at Each Time Point.
Hide Description Data is not available due to study closure and data destruction
Time Frame Baseline, 4, 8 and 12 weeks, change at 12 weeks reported
Outcome Measure Data Not Reported
Time Frame 2 years
Adverse Event Reporting Description Same definition
 
Arm/Group Title Purell VF481 Placebo
Hide Arm/Group Description Active Ingredient: 70% ethanol 15% alcohol formulation that aesthetically resembles VF481
All-Cause Mortality
Purell VF481 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   0/5 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Purell VF481 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   0/5 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Purell VF481 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   0/5 (0.00%) 
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: Eliot Mostow, MD
Organization: Cleveland Clinic Akron General
EMail: emostow@akronderm.com
Layout table for additonal information
Responsible Party: Akron General Medical Center
ClinicalTrials.gov Identifier: NCT00973856     History of Changes
Other Study ID Numbers: 09025
First Submitted: September 8, 2009
First Posted: September 9, 2009
Results First Submitted: July 5, 2017
Results First Posted: July 2, 2019
Last Update Posted: July 2, 2019