Inadequate LubricationNCT01271036
Safety Study of a Sensitive Sensual Touch and Personal Lubricant
A study testing Formula PD-F-7716 in people with Inadequate Lubrication, run by Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inadequate Lubrication
- What is being tested?
- Formula PD-F-7716
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Jan 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Thomas J Stephens & Associates, Inc.
Colorado Springs, Colorado, 80915
About this study
Official title: A Single-Center, Medically Supervised, Safety Evaluation Study of a Sensitive Sensual Touch and Personal Lubricant Product in Couples
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.
Read the 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
- Being tested
- Formula PD-F-7716
- Keywords
- Lubricating Agents, Personal Lubricant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Formula PD-F-7716Device
Also called KY BRAND TOUCH® 2-in-1, Sensitive Massage Lotion and Personal Lubricant
Apply a dime-size amount on each application site as instructed during the 1-week study period
| Study group | Role | What they receive |
|---|---|---|
| Formula PD-F-7716 | Experimental | Apply a dime-size amount on each application site as instructed during the 1-week study period Receives: Device: Formula PD-F-7716 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: One week
Secondary outcomes (4)
Number of Participants Reporting Subjective Irritation - Genital Application 1
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.
Measured: One week
Number of Participants Reporting Subjective Irritation - Genital Application 2
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.
Measured: One week
Number of Participants Reporting Subjective Irritation - Neck Application 1
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.
Measured: One week
Number of Participants Reporting Subjective Irritation - Neck Application 2
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.
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2011 (estimated)
- Study startDec 2010
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Inadequate LubricationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sherryl Frisch, Study director, Johnson & Johnson Consumer and Personal Products Worldwide
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01271036
- Sponsor's protocol ID
- KOYNAP0010
- Status last verified
- Sep 2013
- First submitted
- 4 Jan 2011
- Last updated
- 4 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Medically Supervised, Safety Evaluation Study of a Sensitive Sensual Touch and Personal Lubricant Product in Couples
- ClinicalTrials.gov ID
- NCT01271036
- Acronym / sponsor ID
- KOYNAP0010
- Conditions
- Inadequate Lubrication
- Keywords
- Lubricating Agents, Personal Lubricant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 6 Jan 2011 (estimated)
- Results
- Posted 4 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Formula PD-F-7716 | Experimental | Device: Formula PD-F-7716Apply a dime-size amount on each application site as instructed during the 1-week study period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Formula PD-F-7716Also: KY BRAND TOUCH® 2-in-1, Sensitive Massage Lotion and Personal LubricantApply a dime-size amount on each application site as instructed during the 1-week study period | Device | Formula PD-F-7716 |
Primary outcome
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).
4 secondary outcomes
Number of Participants Reporting Subjective Irritation - Genital Application 1
Time frame: One week
Number of Participants Reporting Subjective Irritation - Genital Application 2
Time frame: One week
Number of Participants Reporting Subjective Irritation - Neck Application 1
Time frame: One week
Number of Participants Reporting Subjective Irritation - Neck Application 2
Time frame: One week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sherryl Frisch study director
Johnson & Johnson Consumer and Personal Products Worldwide
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Formula PD-F-7716 in people with Inadequate Lubrication, run by Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Physical Irritation Scores (time frame: One week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2014.