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

Papillomavirus Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00973856
• Other study ID #: 09025
• Status: Completed
• Phase: N/A
• Start date: September 2009
• Est. completion date: January 2012

Study information

• Verified date: January 2023
• Source: Akron General Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective is to conduct a pilot study to determine the effectiveness of PURELL VF481 to treat warts located on the hands.

Description:

• At least 5, but not more than 20 participants will be enrolled in the study.

• Each wart is randomly assigned a test product prior to the start of the study

• 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

• The test product will be applied to a wooden applicator and gently rubbed into the wart, then covered with a latex free adhesive bandage.

• Subjects will log date and time of application and anything notable (such as changes in wart appearance or missed dose) in a log book.

• Measurement of wart (longest diameter) and photos taken at each visit by trained office medical assistants, LPNs, PA-C or MD.

• Time points for office visitation: Baseline (0 weeks), 4 weeks, 8 weeks, 12 weeks

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: January 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients with 2+ warts being seen at a Dermatologist's office

• 2 or more warts on the hands that are located at least 1 cm apart or on separate fingers

• Warts must have been present for at least 2 months

• Wart size must be between 2 mm-15 mm in diameter

• Participants must be in good general health

• Participants must be able to speak and read in English.

• Participant must be able to read and sign participant instruction sheet, and informed consent and authorization.

• Subjects must be able to understand and execute the instructions presented in pictorial form.

Exclusion Criteria:

• Pregnancy (Patients will be asked to verify using criteria of contraception, menstrual cycle, and pregnancy test, if necessary).

• Treatment of warts with other methods such as salicylic acid, etc., in the past 14 days.

• Known allergies to common topical antimicrobials or the individual ingredients in either test product.

• Participation in a clinical study in the past 7 days or participation in another clinical study

• Unwillingness to perform requirements of the study

• Any medical condition that should preclude participation in the study, at the discretion of the physician

• Missed = 6 of the treatments in a 4 week study period

Related Conditions & MeSH terms

• Condylomata Acuminata
• Epidermodysplasia Verruciformis
• Papillomavirus Infections
• Warts

Intervention

Other:
• 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
• Placebo Solution
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

Locations

Country	Name	City	State
United States	Akron Dermatology	Akron	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Akron General Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in % Reduction in Wart Size Between Product A and Product B at Each Timepoint	Data is not available due to study closure and data destruction	Baseline, 4, 8, and 12 weeks, change at 12 weeks reported
Secondary	Change in Size of Warts Treated by Each Product at Each Time Point.	Data is not available due to study closure and data destruction	Baseline, 4, 8 and 12 weeks, change at 12 weeks reported

External Links

•   Akron General Medical Center