Edema, Erythema
Conditions
Brief summary
Determine the ability of the study material (personal lubricant) to cause sensitization by repeated topical application to the skin of humans under controlled patch test conditions.
Interventions
DEVICEExperimental: Novel lubricant Miami Fragrance
DEVICEExperimental: Novel lubricant Miami no Fragrance
DEVICEKY Liquid lubricant
DEVICEAstroglide Gel lubricant
Sponsors
Church & Dwight Company, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* In general good health * Free of any systemic or dermatologic disorder which, in the opinion of the investigative personnel, will interfere with the study results or increase the risk of adverse events * Are of any skin type or race, providing the skin pigmentation will allow discernment of erythema * Complete a medical screening procedure * Read, understand, and sign an informed consent agreement
Exclusion criteria
* Have any visible skin disease at the study site which, in the opinion of the investigative personnel, will interfere with the evaluation * Are receiving systemic or topical drugs or medication which, in the opinion of the investigative personnel, will interfere with the study results * Have psoriasis and/or active atopic dermatitis/eczema. * Are females who are pregnant, planning on getting pregnant during the study, or breast-feeding * Have a known sensitivity for cosmetics, skin care products, topical drugs, or any other type of the products, as related to the material being evaluated
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability | 24, 48, and 72 hours after patch application |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| HRIPT Novel lubricant Miami w/ fragrance Novel lubricant Miami w/o fragrance 510(k) cleared and currently marketed personal lubricant 510(k) cleared and currently marketed personal lubricant | 201 |
| Total | 201 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 7 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | HRIPT |
|---|---|
| Age, Customized 18-70 | 201 participants |
| Sex: Female, Male Female | 161 Participants |
| Sex: Female, Male Male | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 209 |
| serious Total, serious adverse events | 0 / 209 |
Outcome results
Primary
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time frame: 24, 48, and 72 hours after patch application
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Human Repeat Insult Patch Test | Number of Participants With Adverse Events as a Measure of Safety and Tolerability | 0 participants |