Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
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

Tracking Information
First Submitted Date  ICMJE September 8, 2009
First Posted Date  ICMJE September 9, 2009
Results First Submitted Date  ICMJE July 5, 2017
Results First Posted Date  ICMJE July 2, 2019
Last Update Posted Date July 2, 2019
Study Start Date  ICMJE September 2009
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2019)
Difference in % Reduction in Wart Size Between Product A and Product B at Each Timepoint [ Time Frame: Baseline, 4, 8, and 12 weeks, change at 12 weeks reported ]
Data is not available due to study closure and data destruction
Original Primary Outcome Measures  ICMJE
 (submitted: September 8, 2009)
Difference in % clearance between Product A and Product B at each timepoint [ Time Frame: 4, 8, and 12 weeks ]
Change History Complete list of historical versions of study NCT00973856 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 1, 2019)
Change in Size of Warts Treated by Each Product at Each Time Point. [ Time Frame: Baseline, 4, 8 and 12 weeks, change at 12 weeks reported ]
Data is not available due to study closure and data destruction
Original Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2009)
Change in Size of Warts Treated by Each Product at Each Time Point. [ Time Frame: 4, 8 and 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Effectiveness of an Alcohol Based Hand Gel for the Reduction of Warts on the Hands
Official Title  ICMJE Evaluation of the Effectiveness of an Alcohol Based Hand Gel for the Reduction of Warts on the Hands
Brief Summary The objective is to conduct a pilot study to determine the effectiveness of PURELL VF481 to treat warts located on the hands.
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. 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Papillomavirus Infections
  • Warts
  • Condylomata Acuminata
  • Epidermodysplasia Verruciformis
Intervention  ICMJE
  • 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
  • Other: 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
Study Arms  ICMJE
  • Experimental: PURELL Left Hand/ Placebo Right Hand

    One product will be assigned to each hand to minimize treatment confusion for the participants.

    PURELL VF481 Left Hand/ Placebo Right Hand

    Interventions:
    • Other: PURELL VF481
    • Other: Placebo Solution
  • Placebo Comparator: Placebo Solution Left Hand/ PURELL Right hand

    One (1) product will be assigned to each hand to minimize treatment confusion for the participants PURELL VF481 Right Hand/ Placebo Left Hand

    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

    Interventions:
    • Other: PURELL VF481
    • Other: Placebo Solution
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 22, 2015)
5
Original Estimated Enrollment  ICMJE
 (submitted: September 8, 2009)
20
Actual Study Completion Date  ICMJE January 2012
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00973856
Other Study ID Numbers  ICMJE 09025
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Akron General Medical Center
Study Sponsor  ICMJE Akron General Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eliot Mostow, M.D> Akron General Medical Center
PRS Account Akron General Medical Center
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP