NCT01189617

Safety Study for an All-in-One Body and Personal Lubricant

A Single-center, Medically Supervised, Safety Evaluation Study of an All-in-One Body and Lubricant Product

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a one-week study designed to test the safety of an all-in-one body and personal lubricant product during in-home use.

Detailed description

This is a single-center, medically supervised, single-arm study to evaluate the safety of an all over body and personal lubricant product in home-use conditions via clinical assessment. The study will consist of 2 visits. Subjects who meet the entrance criteria will receive investigational product (IP) and 2 subjective questionnaires for at-home completion. The subjects will be required to use the IP at least 2 times, as instructed over the 1-week home-use period. At the end of the study (visit 2) subjects will return to the study site, at which time the unused IP and questionnaires will be returned and a final clinical assessment will be performed.

Conditions

• Lubricating Agents

Interventions

Type	Name	Description
DEVICE	Formula PD-F-7619	Off-White to Beige Lotion

Timeline

• Start date: 2010-06-01
• Primary completion: 2010-06-01
• Completion: 2010-08-01
• First posted: 2010-08-26
• Last updated: 2017-02-27
• Results posted: 2014-01-10

Locations

1 site across 1 country: United States