NCT01271036

Safety Study of a Sensitive Sensual Touch and Personal Lubricant

A Single-Center, Medically Supervised, Safety Evaluation Study of a Sensitive Sensual Touch and Personal Lubricant Product in Couples

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 124 (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 a personal lubricant during in-home use for subjects who perceive themselves as having sensitive skin.

Detailed description

This is a single-center, medically supervised, single-arm study to evaluate the safety of an all over 2-in-1 sensual touch lotion and personal lubricant product in home-use conditions via clinical assessment. The study will consist of two visits. Subjects who meet the entrance criteria will receive investigational product (IP) and four subjective questionnaires for at-home completion. The subjects will be required to use the IP at least two times on each application site, 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 all unused IP and questionnaires will be returned and a final clinical assessment will be performed.

Conditions

• Inadequate Lubrication

Interventions

Type	Name	Description
DEVICE	Formula PD-F-7716	Apply a dime-size amount on each application site as instructed during the 1-week study period

Timeline

• Start date: 2010-12-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2011-01-06
• Last updated: 2014-03-04
• Results posted: 2014-03-04

Locations

1 site across 1 country: United States