Safety Study of a Sensitive Sensual Touch and Personal Lubricant

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

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.

Study Overview

• Status: Completed
• Conditions: Inadequate Lubrication
• Intervention / Treatment: Device: Formula PD-F-7716

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.

• Study Type: Interventional
• Enrollment (Actual): 124
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Colorado Springs, Colorado, United States, 80915
      • Thomas J Stephens & Associates, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Formula PD-F-7716; Apply a dime-size amount on each application site as instructed during the 1-week study period	Device: Formula PD-F-7716; Apply a dime-size amount on each application site as instructed during the 1-week study period; Other Names: KY BRAND TOUCH® 2-in-1; Sensitive Massage Lotion and Personal Lubricant

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.
• Investigators: Study Director: Sherryl Frisch, Johnson & Johnson Consumer and Personal Products Worldwide

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: January 4, 2011
• First Submitted That Met QC Criteria: January 5, 2011
• First Posted (Estimate): January 6, 2011

Study Record Updates

• Last Update Posted (Estimate): March 4, 2014
• Last Update Submitted That Met QC Criteria: January 30, 2014
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: Personal Lubricant; Lubricating Agents
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: KOYNAP0010