Inadequate Lubrication
Conditions
Keywords
Lubricating Agents, Personal Lubricant
Brief 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.
Interventions
DEVICEFormula PD-F-7716
Apply a dime-size amount on each application site as instructed during the 1-week study period
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 for at least 6 months * Subjects comfortable discussing sensitive topics such as personal hygiene, menstruation and sexuality * At least one partner in the couple has sensitive skin per protocol-defined criteria * 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 within timelines dictated by protocol * Participants with relationships or employment outside protocol-defined parameters
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Physical Irritation Scores | One week | Severity of physical irritation scored by the Investigator 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 study, this any score represents a change from baseline and the trial is considered baseline-controlled. The number of participants with physical irritation scores after one week was recorded (along with categorical severity). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Subjective Irritation - Genital Application 1 | One week | Participants were asked to rate specific sensations they experienced during each application at each site (genital and neck) on a five-point categorical severity scale from mild to excruciating. The sensations included itching, burning, stinging, tingling, warming, and cooling. The number of participants with subjective irritation scores after one week was recorded. |
| Number of Participants Reporting Subjective Irritation - Genital Application 2 | One week | Participants were asked to rate specific sensations they experienced during each application at each site (genital and neck) on a five-point categorical severity scale from mild to excruciating. The sensations included itching, burning, stinging, tingling, warming, and cooling. The number of participants with subjective irritation scores after one week was recorded. |
| Number of Participants Reporting Subjective Irritation - Neck Application 1 | One week | Participants were asked to rate specific sensations they experienced during each application at each site (genital and neck) on a five-point categorical severity scale from mild to excruciating. The sensations included itching, burning, stinging, tingling, warming, and cooling. The number of participants with subjective irritation scores after one week was recorded. |
| Number of Participants Reporting Subjective Irritation - Neck Application 2 | One week | Participants were asked to rate specific sensations they experienced during each application at each site (genital and neck) on a five-point categorical severity scale from mild to excruciating. The sensations included itching, burning, stinging, tingling, warming, and cooling. The number of participants with subjective irritation scores after one week was recorded. |
Countries
United States
Participant flow
Pre-assignment details
Only one IP was used per couple in this single-arm study. At baseline (visit 1), all qualified subjects received the IP for use per protocol.
Participants by arm
| Arm | Count |
|---|---|
| Male Male Participants | 62 |
| Female Female Participants | 62 |
| Total | 124 |
Baseline characteristics
| Characteristic | Female | Total | Male |
|---|---|---|---|
| Age, Continuous | 42.0 years STANDARD_DEVIATION 12.7 | 42.8 years STANDARD_DEVIATION 13.3 | 43.6 years STANDARD_DEVIATION 13.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 62 Participants | 124 Participants | 62 Participants |
| Menopausal Status Postmenopausal | 16 Participants | 16 Participants | NA Participants |
| Menopausal Status Premenopausal | 46 Participants | 46 Participants | NA Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 13 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 53 Participants | 104 Participants | 51 Participants |
| Region of Enrollment United States | 62 participants | 124 participants | 62 participants |
| Sex: Female, Male Female | 62 Participants | 62 Participants | 0 Participants |
| Sex: Female, Male Male | 0 Participants | 62 Participants | 62 Participants |
| Total Couples with Sensitive Skin Couple with Both Partners with Sensitive Skin | 13 participants | 26 participants | 13 participants |
| Total Couples with Sensitive Skin Couple with Female Partner with Sensitive Skin | 46 participants | 46 participants | 0 participants |
| Total Couples with Sensitive Skin Couple with Male Partner with Sensitive Skin | 0 participants | 3 participants | 3 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 7 / 62 | 17 / 62 |
| serious Total, serious adverse events | 0 / 62 | 0 / 62 |
Outcome results
Primary
Number of Participants With Physical Irritation Scores
Severity of physical irritation scored by the Investigator 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 study, this any score represents a change from baseline and the trial is considered baseline-controlled. The number of participants with physical irritation scores after one week was recorded (along with categorical severity).
Time frame: One week
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Male | Number of Participants With Physical Irritation Scores | No Irritation, Either Region | 61 Participants |
| Male | Number of Participants With Physical Irritation Scores | Mild Irritation, Neck Region | 1 Participants |
| Male | Number of Participants With Physical Irritation Scores | Mild Irritation, Genital Region | 0 Participants |
| Female | Number of Participants With Physical Irritation Scores | No Irritation, Either Region | 61 Participants |
| Female | Number of Participants With Physical Irritation Scores | Mild Irritation, Neck Region | 0 Participants |
| Female | Number of Participants With Physical Irritation Scores | Mild Irritation, Genital Region | 1 Participants |
Secondary
Number of Participants Reporting Subjective Irritation - Genital Application 1
Participants were asked to rate specific sensations they experienced during each application at each site (genital and neck) on a five-point categorical severity scale from mild to excruciating. The sensations included itching, burning, stinging, tingling, warming, and cooling. The number of participants with subjective irritation scores after one week was recorded.
Time frame: One week
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Male | Number of Participants Reporting Subjective Irritation - Genital Application 1 | Burning | 1 Participants |
| Male | Number of Participants Reporting Subjective Irritation - Genital Application 1 | Tingling | 7 Participants |
| Male | Number of Participants Reporting Subjective Irritation - Genital Application 1 | Itching | 4 Participants |
| Male | Number of Participants Reporting Subjective Irritation - Genital Application 1 | Warming | 15 Participants |
| Male | Number of Participants Reporting Subjective Irritation - Genital Application 1 | Stinging | 1 Participants |
| Male | Number of Participants Reporting Subjective Irritation - Genital Application 1 | Cooling | 12 Participants |
| Male | Number of Participants Reporting Subjective Irritation - Genital Application 1 | Baseline | 0 Participants |
| Female | Number of Participants Reporting Subjective Irritation - Genital Application 1 | Cooling | 13 Participants |
| Female | Number of Participants Reporting Subjective Irritation - Genital Application 1 | Baseline | 0 Participants |
| Female | Number of Participants Reporting Subjective Irritation - Genital Application 1 | Itching | 3 Participants |
| Female | Number of Participants Reporting Subjective Irritation - Genital Application 1 | Burning | 6 Participants |
| Female | Number of Participants Reporting Subjective Irritation - Genital Application 1 | Stinging | 2 Participants |
| Female | Number of Participants Reporting Subjective Irritation - Genital Application 1 | Tingling | 13 Participants |
| Female | Number of Participants Reporting Subjective Irritation - Genital Application 1 | Warming | 22 Participants |
Secondary
Number of Participants Reporting Subjective Irritation - Genital Application 2
Participants were asked to rate specific sensations they experienced during each application at each site (genital and neck) on a five-point categorical severity scale from mild to excruciating. The sensations included itching, burning, stinging, tingling, warming, and cooling. The number of participants with subjective irritation scores after one week was recorded.
Time frame: One week
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Male | Number of Participants Reporting Subjective Irritation - Genital Application 2 | Burning | 1 Participants |
| Male | Number of Participants Reporting Subjective Irritation - Genital Application 2 | Tingling | 5 Participants |
| Male | Number of Participants Reporting Subjective Irritation - Genital Application 2 | Itching | 2 Participants |
| Male | Number of Participants Reporting Subjective Irritation - Genital Application 2 | Warming | 17 Participants |
| Male | Number of Participants Reporting Subjective Irritation - Genital Application 2 | Stinging | 1 Participants |
| Male | Number of Participants Reporting Subjective Irritation - Genital Application 2 | Cooling | 12 Participants |
| Male | Number of Participants Reporting Subjective Irritation - Genital Application 2 | Baseline | 0 Participants |
| Female | Number of Participants Reporting Subjective Irritation - Genital Application 2 | Cooling | 10 Participants |
| Female | Number of Participants Reporting Subjective Irritation - Genital Application 2 | Baseline | 0 Participants |
| Female | Number of Participants Reporting Subjective Irritation - Genital Application 2 | Itching | 1 Participants |
| Female | Number of Participants Reporting Subjective Irritation - Genital Application 2 | Burning | 5 Participants |
| Female | Number of Participants Reporting Subjective Irritation - Genital Application 2 | Stinging | 1 Participants |
| Female | Number of Participants Reporting Subjective Irritation - Genital Application 2 | Tingling | 10 Participants |
| Female | Number of Participants Reporting Subjective Irritation - Genital Application 2 | Warming | 18 Participants |
Secondary
Number of Participants Reporting Subjective Irritation - Neck Application 1
Participants were asked to rate specific sensations they experienced during each application at each site (genital and neck) on a five-point categorical severity scale from mild to excruciating. The sensations included itching, burning, stinging, tingling, warming, and cooling. The number of participants with subjective irritation scores after one week was recorded.
Time frame: One week
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Male | Number of Participants Reporting Subjective Irritation - Neck Application 1 | Burning | 1 Participants |
| Male | Number of Participants Reporting Subjective Irritation - Neck Application 1 | Tingling | 4 Participants |
| Male | Number of Participants Reporting Subjective Irritation - Neck Application 1 | Itching | 1 Participants |
| Male | Number of Participants Reporting Subjective Irritation - Neck Application 1 | Warming | 10 Participants |
| Male | Number of Participants Reporting Subjective Irritation - Neck Application 1 | Stinging | 2 Participants |
| Male | Number of Participants Reporting Subjective Irritation - Neck Application 1 | Cooling | 14 Participants |
| Male | Number of Participants Reporting Subjective Irritation - Neck Application 1 | Baseline | 0 Participants |
| Female | Number of Participants Reporting Subjective Irritation - Neck Application 1 | Cooling | 15 Participants |
| Female | Number of Participants Reporting Subjective Irritation - Neck Application 1 | Baseline | 0 Participants |
| Female | Number of Participants Reporting Subjective Irritation - Neck Application 1 | Itching | 2 Participants |
| Female | Number of Participants Reporting Subjective Irritation - Neck Application 1 | Burning | 0 Participants |
| Female | Number of Participants Reporting Subjective Irritation - Neck Application 1 | Stinging | 1 Participants |
| Female | Number of Participants Reporting Subjective Irritation - Neck Application 1 | Tingling | 8 Participants |
| Female | Number of Participants Reporting Subjective Irritation - Neck Application 1 | Warming | 13 Participants |
Secondary
Number of Participants Reporting Subjective Irritation - Neck Application 2
Participants were asked to rate specific sensations they experienced during each application at each site (genital and neck) on a five-point categorical severity scale from mild to excruciating. The sensations included itching, burning, stinging, tingling, warming, and cooling. The number of participants with subjective irritation scores after one week was recorded.
Time frame: One week
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Male | Number of Participants Reporting Subjective Irritation - Neck Application 2 | Warming | 10 Participants |
| Male | Number of Participants Reporting Subjective Irritation - Neck Application 2 | Baseline | 0 Participants |
| Male | Number of Participants Reporting Subjective Irritation - Neck Application 2 | Itching | 2 Participants |
| Male | Number of Participants Reporting Subjective Irritation - Neck Application 2 | Burning | 1 Participants |
| Male | Number of Participants Reporting Subjective Irritation - Neck Application 2 | Stinging | 1 Participants |
| Male | Number of Participants Reporting Subjective Irritation - Neck Application 2 | Tingling | 1 Participants |
| Male | Number of Participants Reporting Subjective Irritation - Neck Application 2 | Cooling | 16 Participants |
| Female | Number of Participants Reporting Subjective Irritation - Neck Application 2 | Warming | 12 Participants |
| Female | Number of Participants Reporting Subjective Irritation - Neck Application 2 | Stinging | 0 Participants |
| Female | Number of Participants Reporting Subjective Irritation - Neck Application 2 | Baseline | 0 Participants |
| Female | Number of Participants Reporting Subjective Irritation - Neck Application 2 | Cooling | 15 Participants |
| Female | Number of Participants Reporting Subjective Irritation - Neck Application 2 | Itching | 4 Participants |
| Female | Number of Participants Reporting Subjective Irritation - Neck Application 2 | Tingling | 9 Participants |
| Female | Number of Participants Reporting Subjective Irritation - Neck Application 2 | Burning | 0 Participants |