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

NCT ID: NCT00973856

Last Updated: 2023-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2012-01-31

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

Conditions

Papillomavirus Infections; Warts; Condylomata Acuminata; Epidermodysplasia Verruciformis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

PURELL VF481

Intervention Type: OTHER

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

Placebo Solution

Intervention Type: OTHER

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

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

Group Type: PLACEBO_COMPARATOR

PURELL VF481

Intervention Type: OTHER

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

Placebo Solution

Intervention Type: OTHER

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

Interventions

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

Intervention Type: 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

Intervention Type: OTHER

Other Intervention Names

PURELL VF481 alcohol based hand gel

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cleveland Clinic Akron General

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eliot Mostow, M.D>

Role: PRINCIPAL_INVESTIGATOR

Cleveland Clinic Akron General

Locations

Akron Dermatology

Akron, Ohio, United States

Countries

United States

Related Links

http://www.akrongeneral.org

Akron General Medical Center

Other Identifiers

09025

Identifier Type: -

Identifier Source: org_study_id