Safety Study of a Sensitive Sensual Touch and Personal Lubricant

Not Applicable

Completed

Conditions: Inadequate Lubrication

Interventions: Device: Formula PD-F-7716

Registration Number: NCT01271036

Lead Sponsor: Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 124

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Formula PD-F-7716	Formula PD-F-7716	Apply a dime-size amount on each application site as instructed during the 1-week study period

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.