Safety Study of a Sensitive Sensual Touch and Personal Lubricant

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Single-Center, Medically Supervised, Safety Evaluation Study of a Sensitive Sensual Touch and Personal Lubricant Product in Couples

Conditions
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Inadequate Lubrication

Intervention / Treatment
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* Device: Formula PD-F-7716


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Formula PD-F-7716<br>Apply a dime-size amount on each application site as instructed during the 1-week study period | Device: Formula PD-F-7716<br>* Apply a dime-size amount on each application site as instructed during the 1-week study period<br>* Other names: Sensitive Massage Lotion and Personal Lubricant;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lubricating Agents, Personal Lubricant