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

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ClinicalTrials.gov Identifier: NCT00973856
Recruitment Status : Completed
First Posted : September 9, 2009
Last Update Posted : June 23, 2015
Sponsor:
Information provided by (Responsible Party):
Akron General Medical Center

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

Condition or disease Intervention/treatment Phase
Papillomavirus Infections Warts Condylomata Acuminata Epidermodysplasia Verruciformis Other: PURELL VF481 Other: Placebo Comparator Not Applicable

Detailed 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 (2, 4, or 6), when possible 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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Effectiveness of an Alcohol Based Hand Gel for the Reduction of Warts on the Hands
Study Start Date : September 2009
Actual Primary Completion Date : December 2011
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Warts

Arm Intervention/treatment
Experimental: PURELL VF481
Warts are equally distributed between products so that an equal number of warts treated on each person (2, 4, or 6), when possible one (1) product will be assigned to each hand to minimize treatment confusion for the participants
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
Other Name: PURELL VF481 alcohol based hand gel

Placebo Comparator: Placebo Solution

Warts are equally distributed between products so that an equal number of warts treated on each person (2, 4, or 6), when possible 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

Other: 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




Primary Outcome Measures :
  1. Difference in % clearance between Product A and Product B at each timepoint [ Time Frame: 4, 8, and 12 weeks ]

Secondary Outcome Measures :
  1. Change in size of warts treated by each product at each time point. [ Time Frame: 4, 8 and 12 weeks ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00973856


Locations
United States, Ohio
Akron Dermatology
Akron, Ohio, United States, 44307
Sponsors and Collaborators
Akron General Medical Center
Investigators
Principal Investigator: Eliot Mostow, M.D> Akron General Medical Center

Additional Information:
Responsible Party: Akron General Medical Center
ClinicalTrials.gov Identifier: NCT00973856     History of Changes
Other Study ID Numbers: 09025
First Posted: September 9, 2009    Key Record Dates
Last Update Posted: June 23, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Warts
Papillomavirus Infections
Epidermodysplasia Verruciformis
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs