Safety Study of a Sensitive Sensual Touch and Personal Lubricant

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc. )
ClinicalTrials.gov Identifier:
NCT01271036
First received: January 4, 2011
Last updated: January 30, 2014
Last verified: September 2013
  Purpose

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.


Condition Intervention
Inadequate Lubrication
Device: Formula PD-F-7716

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Single-Center, Medically Supervised, Safety Evaluation Study of a Sensitive Sensual Touch and Personal Lubricant Product in Couples

Further study details as provided by Johnson & Johnson Consumer and Personal Products Worldwide:

Primary Outcome Measures:
  • Number of Participants With Physical Irritation Scores [ Time Frame: One week ] [ Designated as safety issue: No ]
    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:
  • Number of Participants Reporting Subjective Irritation - Genital Application 1 [ Time Frame: One week ] [ Designated as safety issue: No ]
    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 [ Time Frame: One week ] [ Designated as safety issue: No ]
    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 [ Time Frame: One week ] [ Designated as safety issue: No ]
    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 [ Time Frame: One week ] [ Designated as safety issue: No ]
    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.


Enrollment: 124
Study Start Date: December 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01271036

Locations
United States, Colorado
Thomas J Stephens & Associates, Inc.
Colorado Springs, Colorado, United States, 80915
Sponsors and Collaborators
Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.
Investigators
Study Director: Sherryl Frisch Johnson & Johnson Consumer and Personal Products Worldwide
  More Information

No publications provided

Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc. )
ClinicalTrials.gov Identifier: NCT01271036     History of Changes
Other Study ID Numbers: KOYNAP0010
Study First Received: January 4, 2011
Results First Received: April 26, 2013
Last Updated: January 30, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Consumer and Personal Products Worldwide:
Lubricating Agents
Personal Lubricant

ClinicalTrials.gov processed this record on August 27, 2014