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


N/A
18 Years
65 Years
Open (Enrolling)
Both
Papillomavirus Infections, Warts, Condylomata Acuminata, Epidermodysplasia Verruciformis

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Trial Information

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


- 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


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

Type of Study:

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

Outcome Measure:

Difference in % clearance between Product A and Product B at each timepoint

Outcome Time Frame:

4, 8, and 12 weeks

Safety Issue:

No

Principal Investigator

Eliot Mostow, M.D>

Investigator Role:

Principal Investigator

Investigator Affiliation:

Akron General Medical Center

Authority:

United States: Institutional Review Board

Study ID:

09025

NCT ID:

NCT00973856

Start Date:

September 2009

Completion Date:

December 2010

Related Keywords:

  • Papillomavirus Infections
  • Warts
  • Condylomata Acuminata
  • Epidermodysplasia Verruciformis
  • Condylomata Acuminata
  • Epidermodysplasia Verruciformis
  • Warts
  • Papillomavirus Infections

Name

Location

Akron DermatologyAkron, Ohio  44307