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

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

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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