Safety Study of a Sensitive Sensual Touch and Personal Lubricant

McNeil-PPC

Status: Completed

Conditions: Inadequate Lubrication

Treatments: Device: Formula PD-F-7716

Study type: Interventional

Funder types: Industry

Identifiers

NCT01271036

KOYNAP0010

Details and patient eligibility

About

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.

Full 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.

Enrollment: 124 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

124 participants in 1 patient group

Formula PD-F-7716

Experimental group

Description:

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

Treatment:

Device: Formula PD-F-7716