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Safety Study of a Sensitive Sensual Touch and Personal Lubricant

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01271036
Recruitment Status : Completed
First Posted : January 6, 2011
Results First Posted : March 4, 2014
Last Update Posted : March 4, 2014
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc. )

Study Description
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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.

Condition or disease Intervention/treatment Phase
Inadequate Lubrication Device: Formula PD-F-7716 Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A Single-Center, Medically Supervised, Safety Evaluation Study of a Sensitive Sensual Touch and Personal Lubricant Product in Couples
Study Start Date : December 2010
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Physical Irritation Scores [ Time Frame: 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 :
  1. Number of Participants Reporting Subjective Irritation - Genital Application 1 [ Time Frame: 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.

  2. Number of Participants Reporting Subjective Irritation - Genital Application 2 [ Time Frame: 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.

  3. Number of Participants Reporting Subjective Irritation - Neck Application 1 [ Time Frame: 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.

  4. Number of Participants Reporting Subjective Irritation - Neck Application 2 [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01271036


Locations
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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
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Study Director: Sherryl Frisch Johnson & Johnson Consumer and Personal Products Worldwide
More Information
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Responsible Party: Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.
ClinicalTrials.gov Identifier: NCT01271036    
Other Study ID Numbers: KOYNAP0010
First Posted: January 6, 2011    Key Record Dates
Results First Posted: March 4, 2014
Last Update Posted: March 4, 2014
Last Verified: September 2013
Keywords provided by Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc. ):
Lubricating Agents
Personal Lubricant
Additional relevant MeSH terms:
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Hypersensitivity
Immune System Diseases