Safety Study of a Sensitive Sensual Tou… | Clinical Trial

Key information

Conditions

Inadequate Lubrication

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Thomas J Stephens & Associates, Inc.

Colorado Springs, Colorado, 80915, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Formula PD-F-7716

Device

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

Primary outcomes

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 outcomes

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.
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.
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.
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.

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

A Single-Center, Medically Supervised, Safety Evaluation Study of a Sensitive Sensual Touch and Personal Lubricant Product in Couples

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: Jan 6, 2011
Registry last updated: Mar 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.