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

NCT00973856 | Completed Results

• 1 other identifier: 09025
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Papillomavirus Infections; Warts; Condylomata Acuminata; Epidermodysplasia Verruciformis

Outcome Measures

Primary Outcomes (1)

• Difference in % Reduction in Wart Size Between Product A and Product B at Each Timepoint

  Data is not available due to study closure and data destruction

  Baseline, 4, 8, and 12 weeks, change at 12 weeks reported

Secondary Outcomes (1)

• Change in Size of Warts Treated by Each Product at Each Time Point.

  Baseline, 4, 8 and 12 weeks, change at 12 weeks reported

Study Arms (2)

PURELL Left Hand/ Placebo Right Hand

EXPERIMENTAL

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

Other: PURELL VF481; Other: Placebo Solution

Placebo Solution Left Hand/ PURELL Right hand

PLACEBO COMPARATOR

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

Other: PURELL VF481; Other: Placebo Solution

Interventions

PURELL VF481 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

Also known as: PURELL VF481 alcohol based hand gel

PURELL Left Hand/ Placebo Right Hand; Placebo Solution Left Hand/ PURELL Right hand

Placebo Solution 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

PURELL Left Hand/ Placebo Right Hand; Placebo Solution Left Hand/ PURELL Right hand

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with 2+ warts being seen at a Dermatologist's office
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cleveland Clinic Akron General: lead

Study Sites (1)

Akron Dermatology

Akron, Ohio, 44307, United States

Location

Related Links

• Akron General Medical Center

MeSH Terms

Conditions

Papillomavirus Infections; Warts; Condylomata Acuminata; Epidermodysplasia Verruciformis

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Diseases, Viral; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Results Point of Contact

• Title: Eliot Mostow, MD
• Organization: Cleveland Clinic Akron General

emostow@akronderm.com

Study Officials

• Eliot Mostow, M.D>

  Cleveland Clinic Akron General

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2009
• First Posted: September 9, 2009
• Study Start: September 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: January 1, 2012
• Last Updated: January 31, 2023
• Results First Posted: July 2, 2019

Record last verified: 2023-01

Locations

US (1)