Safety Study of a Sensitive Sensual Touch and Personal Lubricant

NCT01271036 | Completed Results

• 1 other identifier: KOYNAP0010
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Inadequate Lubrication

Keywords

Lubricating Agents; Personal Lubricant

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of Participants Reporting Subjective Irritation - Genital Application 1

  One week

• Number of Participants Reporting Subjective Irritation - Genital Application 2

  One week

• Number of Participants Reporting Subjective Irritation - Neck Application 1

  One week

• Number of Participants Reporting Subjective Irritation - Neck Application 2

  One week

Study Arms (1)

Formula PD-F-7716

EXPERIMENTAL

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

Device: Formula PD-F-7716

Interventions

Formula PD-F-7716 DEVICE

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

Also known as: KY BRAND TOUCH® 2-in-1, Sensitive Massage Lotion and Personal Lubricant

Formula PD-F-7716

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Thomas J Stephens & Associates, Inc.

Colorado Springs, Colorado, 80915, United States

Location

Results Point of Contact

• Title: Joyce Hauze, Sr. Specialist
• Organization: Johnson & Johnson Consumer and Personal Products Worldwide

jhauze@its.jnj.com

928-277-0715

Study Officials

• Sherryl Frisch

  Johnson & Johnson Consumer and Personal Products Worldwide

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2011
• First Posted: January 6, 2011
• Study Start: December 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: March 4, 2014
• Results First Posted: March 4, 2014

Record last verified: 2013-09

Locations

US (1)