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

January 11, 2017 updated by: Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46240
        • Concentrics Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: Formula PD-F-7619
Off-White to Beige Lotion
Other Names:
  • All-In-One Caressing Crème & Personal Lubricant
  • K-Y Touch Massage Warming 2-in-1 Personal Lubricant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects With Irritation Score of "0" at Baseline and One Week
Time Frame: 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.
Baseline and One Week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.

Investigators

  • Study Director: Sherryl Frisch, Johnson & Johnson Consumer and Personal Products Worldwide
  • Study Director: Melissa Israel, Johnson & Johnson Consumer and Personal Products Worldwide

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

August 25, 2010

First Submitted That Met QC Criteria

August 25, 2010

First Posted (Estimate)

August 26, 2010

Study Record Updates

Last Update Posted (Actual)

February 27, 2017

Last Update Submitted That Met QC Criteria

January 11, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KOYNAP0011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lubricating Agents

Clinical Trials on Formula PD-F-7619

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Venezuela

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe