Trial Outcomes & Findings for Evaluation of the Effectiveness of an Alcohol Based Hand Gel for the Reduction of Warts on the Hands (NCT NCT00973856)

Results Overview

Data is not available due to study closure and data destruction

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

5 participants

Primary outcome timeframe

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

Results posted on

2023-01-31

Participant Flow

There were no pre-assignment details. Once consented, pts were enrolled into both study arms.

Unit of analysis: warts,not pts assigned to intervention

Participant milestones

Participant milestones
Measure	PURELL VF481 Left Hand/ Placebo Right Hand 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 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	Placebo Solution Left Hand/ PURELL VF481 Right Hand 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 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 Comparator: 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
Overall Study STARTED	3 5	2 5
Overall Study COMPLETED	3 5	2 5
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PURELL VF481 Left Hand/ Placebo Right Hand n=5 warts 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 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	Placebo Solution Left Hand/ PURELL VF481 Right Hand n=5 warts 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 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 Comparator: 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	Total n=10 warts Total of all reporting groups
Age, Categorical <=18 years	0 warts n=5 warts	0 warts n=5 warts	0 warts n=10 warts
Age, Categorical Between 18 and 65 years	5 warts n=5 warts	5 warts n=5 warts	10 warts n=10 warts
Age, Categorical >=65 years	0 warts n=5 warts	0 warts n=5 warts	0 warts n=10 warts
Sex/Gender, Customized Sex/Gender unspecified	5 warts n=5 warts	5 warts n=5 warts	10 warts n=10 warts
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	5 participants n=5 warts	5 participants n=5 warts	10 participants n=10 warts

PRIMARY outcome

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

Population: Data is not available due to study closure and data destruction

Data is not available due to study closure and data destruction

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Population: Data is not available due to study closure and data destruction

Data is not available due to study closure and data destruction

Outcome measures

Outcome data not reported

Adverse Events

Purell VF481

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Eliot Mostow, MD

Cleveland Clinic Akron General

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place