Safety Study of a Sensitive Sensual Touch and Personal Lubricant

NCT ID: NCT01271036

Last Updated: 2014-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2011-01-31

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.

Conditions

Inadequate Lubrication

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Formula PD-F-7716

Apply a dime-size amount on each application site as instructed during the 1-week study period

Group Type: EXPERIMENTAL

Formula PD-F-7716

Intervention Type: DEVICE

Apply a dime-size amount on each application site as instructed during the 1-week study period

Interventions

Formula PD-F-7716

Apply a dime-size amount on each application site as instructed during the 1-week study period

Intervention Type: DEVICE

Other Intervention Names

KY BRAND TOUCH® 2-in-1; Sensitive Massage Lotion and Personal Lubricant

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sherryl Frisch

Role: STUDY_DIRECTOR

Johnson & Johnson Consumer and Personal Products Worldwide

Locations

Thomas J Stephens & Associates, Inc.

Colorado Springs, Colorado, United States

Countries

United States

Other Identifiers

KOYNAP0010

Identifier Type: -

Identifier Source: org_study_id