Clinical trial NCT01271036: Safety Study of a Sensitive Sensual Touch and Personal Lubricant
Official title: A Single-Center, Medically Supervised, Safety Evaluation Study of a Sensitive Sensual Touch and Personal Lubricant Product in Couples
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inadequate Lubrication
Keywords: Lubricating Agents
Personal Lubricant
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2011-01-06
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

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.

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

Primary outcomes:
measure: Number of Participants With Physical Irritation Scores
timeFrame: One week
Secondary outcomes:
measure: Number of Participants Reporting Subjective Irritation - Genital Application 1
timeFrame: One week
measure: Number of Participants Reporting Subjective Irritation - Genital Application 2
timeFrame: One week
measure: Number of Participants Reporting Subjective Irritation - Neck Application 1
timeFrame: One week
measure: Number of Participants Reporting Subjective Irritation - Neck Application 2
timeFrame: One week
Other outcomes:
Locations:
city: Colorado Springs
country: United States
facility: Thomas J Stephens & Associates, Inc.
state: Colorado
Study officials:
affiliation: Johnson & Johnson Consumer and Personal Products Worldwide
name: Sherryl Frisch
role: STUDY_DIRECTOR
References: