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

C

Cleveland Clinic Akron General

Status

Completed

Conditions

Condylomata Acuminata
Epidermodysplasia Verruciformis
Papillomavirus Infections
Warts

Treatments

Other: Placebo Solution
Other: PURELL VF481

Study type

Interventional

Funder types

Other

Identifiers

NCT00973856
09025

Details and patient eligibility

About

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

Full 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

Enrollment

5 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

5 participants in 2 patient groups, including a placebo group

PURELL Left Hand/ Placebo Right Hand
Experimental group
Description:
One product will be assigned to each hand to minimize treatment confusion for the participants. PURELL VF481 Left Hand/ Placebo Right Hand
Treatment:
Other: PURELL VF481
Other: Placebo Solution
Placebo Solution Left Hand/ PURELL Right hand
Placebo Comparator group
Description:
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
Treatment:
Other: PURELL VF481
Other: Placebo Solution

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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