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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Formula PD-F-7716 | Experimental | Apply a dime-size amount on each application site as instructed during the 1-week study period |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Formula PD-F-7716 | Device | Apply a dime-size amount on each application site as instructed during the 1-week study period |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | One week |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas J Stephens & Associates, Inc. | Colorado Springs | Colorado | 80915 | United States |
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Males | Male Participants (K-Y Brand TOUCH 2-in-1) |
| FG001 | Female | Female Participants (K-Y Brand TOUCH 2-in-1) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Full Analysis Set
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| ID | Title | Description |
|---|---|---|
| BG000 | Male | Male Participants |
| BG001 | Female | Female Participants |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
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| 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 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). | Full Analysis Set | Posted | Number | Participants | One week |
|
1 Week (+30 days for Serious Adverse Events, and beyond if assessed as possibly treatment related)
Adverse Events were collected from all study subjects via subjective questionnaire and physical examination. Participants are counted one time for each adverse event they experienced.
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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 (e.g., burning, stinging) | General disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joyce Hauze, Sr. Specialist | Johnson & Johnson Consumer and Personal Products Worldwide | 928-277-0715 | jhauze@its.jnj.com |
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| One week |
| 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. | One week |
| 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. | One week |
| 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. | One week |
| Total |
Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Menopausal Status | Number | Participants |
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| Total Couples with Sensitive Skin | Number | participants |
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|
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| 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. | Full Analysis Set | Posted | Number | Participants | One week |
|
|
|
| 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. | Full Analysis Set | Posted | Number | Participants | One week |
|
|
|
| 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. | Full Analysis Set | Posted | Number | Participants | One week |
|
|
|
| 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. | Full Analysis Set | Posted | Number | Participants | One week |
|
|
|
| 0 |
| 62 |
| 7 |
| 62 |
| EG001 | Female | Female Participants | 0 | 62 | 17 | 62 |
| Application Site Pruritus (e.g., itching) | General disorders | MedDRA | Systematic Assessment |
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| Application Site Erythema | General disorders | MedDRA | Systematic Assessment |
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| Application Site Excoriation | General disorders | MedDRA | Systematic Assessment |
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| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Ankle Fracture | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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Study is considered a work made for hire and the Sponsor retains all rights to publish results.
| Burning |
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| Stinging |
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| Tingling |
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| Warming |
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| Cooling |
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| Burning |
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| Stinging |
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| Tingling |
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| Warming |
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| Cooling |
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| Burning |
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| Stinging |
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| Tingling |
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| Warming |
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| Cooling |
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| Burning |
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| Stinging |
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| Tingling |
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| Warming |
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| Cooling |
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