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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Formula PD-F-7619 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Formula PD-F-7619 | Device | Off-White to Beige Lotion |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and One Week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sherryl Frisch | Johnson & Johnson Consumer and Personal Products Worldwide | Study Director |
| Melissa Israel | Johnson & Johnson Consumer and Personal Products Worldwide | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Concentrics Research | Indianapolis | Indiana | 46240 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Male | Male Participants |
| FG001 | Female | Female Participants |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Full Analysis Set
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| ID | Title | Description |
|---|---|---|
| BG000 | Male | Male Participants |
| BG001 | Female | Female Participants |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Full Analysis Set | Posted | Number | Participants | Baseline and One Week |
|
1 Week (+30 days for Serious Adverse Events, and beyond if assessed as possibly treatment related)
Subjects reported adverse events on questionnaires, and site staff recorded changes in medical status/history since study start. Itching, burning and stinging counted as adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Male | Male Participants |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application Site Pain (burning, stinging) | General disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joyce Hauze, Sr. Specialist | Johnson & Johsnon Consumer and Personal Products Worldwide | 9285-277-0715 | jhauze@its.jnj.com |
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| Total |
Total of all reporting groups |
| years |
|
| Gender | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
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| Region of Enrollment | Number | participants |
|
| Female Sub-Typing - Menopausal State | Number | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 35 |
| 2 |
| 35 |
| EG001 | Female | Female Participants | 0 | 35 | 2 | 35 |
| Application Site Erythema (redness) | General disorders | MedDRA | Systematic Assessment |
|
Study is considered a work made for hire and the Sponsor retains all rights to publish results.