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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Akron General Medical Center
ClinicalTrials.gov Identifier:
NCT00973856
First received: September 8, 2009
Last updated: June 22, 2015
Last verified: June 2015
  Purpose

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


Condition Intervention
Papillomavirus Infections
Warts
Condylomata Acuminata
Epidermodysplasia Verruciformis
Other: PURELL VF481
Other: Placebo Comparator

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Akron General Medical Center:

Primary Outcome Measures:
  • Difference in % clearance between Product A and Product B at each timepoint [ Time Frame: 4, 8, and 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in size of warts treated by each product at each time point. [ Time Frame: 4, 8 and 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: September 2009
Study Completion Date: January 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

Responsible Party: Akron General Medical Center
ClinicalTrials.gov Identifier: NCT00973856     History of Changes
Other Study ID Numbers: 09025
Study First Received: September 8, 2009
Last Updated: June 22, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Epidermodysplasia Verruciformis
Papillomavirus Infections
Warts
DNA Virus Infections
Neoplasms
Skin Diseases
Skin Diseases, Infectious
Skin Diseases, Viral
Tumor Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on July 29, 2015