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

Not Applicable

Completed

• Conditions: Lubricating Agents
• Interventions: Device: Formula PD-F-7619

• Registration Number: NCT01189617
• Lead Sponsor: Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.

Brief 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.

Study Timeline

• Study Start: 2010-06
• Primary Completion: 2010-06
• Study Completion: 2010-08
• Study First Submitted: 2010-08-25
• Study First Submitted QC: 2010-08-25
• Study First Posted: 2010-08-26
• Results First Submitted: 2013-04-26
• Results First Submitted QC: 2013-12-09
• Results First Posted: 2014-01-10
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-11
• Last Update Posted: 2017-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Normal, healthy adults in a stable, monogamous, ongoing heterosexual relationship with current partner within protocol-specified parameters
• Subjects comfortable discussing sensitive topics such as personal hygiene, menstruation and sexuality
• Able to read and understand English
• Voluntarily signs an Informed Consent document after the trial has been explained
• Willing to follow all study procedures, including birth control requirements

Exclusion Criteria

• Any medical or mental health history or condition, or use of any product, drug or medication that per protocol (or in the opinion of the Investigator) might compromise the participant's safety or the analysis of results
• Participation as a research subject in a different trial within timelines dictated by protocol
• Participants with relationships or employment outside protocol-defined parameters

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Formula PD-F-7619	Formula PD-F-7619	At least twice per week for one week, massage about a dime-sized amount of the PD-F-7619 personal lubricant product to the application site as directed.

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Irritation Score of "0" at Baseline and One Week	Baseline and One Week	Severity of irritation on a scale from 0 (No Irritation) to 6 (Presence of Lesions). Since a score of 0 is required at baseline for inclusion in the trial, this score represents a change from baseline and the trial is considered baseline-controlled.

Trial Locations

Locations (1)

Concentrics Research; 🇺🇸 Indianapolis, Indiana, United States