N/A
N=124
Safety Study of a Sensitive Sensual Touch and Personal Lubricant
Inadequate Lubrication
Bottom Line
View on ClinicalTrials.gov: NCT01271036 ↗Enrolled (actual)
124
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcome: Primary: Number of Participants With Physical Irritation Scores — 61; 61; 1; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Formula PD-F-7716 (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.
- Primary completion
- Jan 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Physical Irritation Scores |
61; 61; 1; 0; 0; 1 | — |
| SECONDARY Number of Participants Reporting Subjective Irritation - Genital Application 1 |
0; 0; 4; 3; 1; 6 | — |
| SECONDARY Number of Participants Reporting Subjective Irritation - Genital Application 2 |
0; 0; 2; 1; 1; 5 | — |
| SECONDARY Number of Participants Reporting Subjective Irritation - Neck Application 1 |
0; 0; 1; 2; 1; 0 | — |
| SECONDARY Number of Participants Reporting Subjective Irritation - Neck Application 2 |
0; 0; 2; 4; 1; 0 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01271036). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.