Lubricating Agents
Conditions
Keywords
Personal Lubricant
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.
Interventions
DEVICEFormula PD-F-7619
Off-White to Beige Lotion
Sponsors
Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Male Male Participants | 35 |
| Female Female Participants | 35 |
| Total | 70 |
Baseline characteristics
| Characteristic | Male | Female | Total |
|---|---|---|---|
| Age, Continuous | 51.2 years STANDARD_DEVIATION 12.8 | 49.3 years STANDARD_DEVIATION 12.8 | 50.25 years STANDARD_DEVIATION 12.8 |
| Female Sub-Typing - Menopausal State Postmenopausal | NA Participants | 17 Participants | 17 Participants |
| Female Sub-Typing - Menopausal State Premenopausal | NA Participants | 18 Participants | 18 Participants |
| Gender Female | 0 Participants | 35 Participants | 35 Participants |
| Gender Male | 35 Participants | 0 Participants | 35 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African-American | 13 Participants | 9 Participants | 22 Participants |
| Race/Ethnicity, Customized Other [unknown] | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 21 Participants | 25 Participants | 46 Participants |
| Region of Enrollment United States | 35 participants | 35 participants | 70 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 35 | 2 / 35 |
| serious Total, serious adverse events | 0 / 35 | 0 / 35 |
Outcome results
Primary
Number of Subjects With Irritation Score of 0 at 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.
Time frame: Baseline and One Week
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Male | Number of Subjects With Irritation Score of 0 at Baseline and One Week | Visit 1 - Baseline | 35 Participants |
| Male | Number of Subjects With Irritation Score of 0 at Baseline and One Week | Visit 2 - One Week | 35 Participants |
| Female | Number of Subjects With Irritation Score of 0 at Baseline and One Week | Visit 1 - Baseline | 35 Participants |
| Female | Number of Subjects With Irritation Score of 0 at Baseline and One Week | Visit 2 - One Week | 35 Participants |