Safety Study for an All-in-One Body 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 an all-in-one body and personal lubricant product during in-home use.

Detailed Description
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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.

Official Title
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A Single-center, Medically Supervised, Safety Evaluation Study of an All-in-One Body and Lubricant Product

Conditions
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Lubricating Agents

Intervention / Treatment
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* Device: Formula PD-F-7619


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 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

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-7619<br>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. | Device: Formula PD-F-7619<br>* Off-White to Beige Lotion<br>* Other names: K-Y Touch Massage Warming 2-in-1 Personal Lubricant;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

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