Cumulative Irritation
Conditions
Keywords
Patch Test
Brief summary
The objective of this study is to determine the ability of the study material to cause irritation to the skin of humans under controlled patch test conditions. Substances that come into contact with human skin need to be evaluated for their propensity to irritate and/or sensitize. This testing is a modified primary irritancy patch test that can detect weak irritants that require multiple applications to cause a skin reaction.
Interventions
DEVICENovel lubricant Miami w/ fragrance
0.2 ml aliquot on occlusive patch
DEVICENovel lubricant Miami no fragrance
0.2 ml aliquot on occlusive patch
DEVICEKY Liquid lubricant
0.2 ml aliquot on occlusive patch
DEVICEAstroglide Gel lubricant
0.2 ml aliquot on occlusive patch
DEVICEWet Platinum lubricant
0.2 ml aliquot on occlusive patch
Sponsors
Church & Dwight Company, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Are a male or female, 18 years of age or older, in general good health; * Have normal skin; * Are 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; and * Read, understand, and sign an informed consent.
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 systematic 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; and/or * Have a known sensitivity to cosmetics, skin care products, or topical drugs as related to the material being evaluated.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects That Showed no Significant Irritation | 14 days | Score of less than or equal to 1.2 on the Cumulative Irritation Test scale (0-5). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Healthy Subject Occlusive patches applied each day for 14 days for each intervention (Experimental: Novel lubricant Miami w/ fragrance, Experimental: Novel lubricant Miami no fragrance, KY Liquid lubricant, Astroglide Gel lubricant, Wet Platinum lubricant). | 41 |
| Total | 41 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Healthy Subject |
|---|---|
| Age, Customized 20-72 | 41 participants |
| Sex: Female, Male Female | 31 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 41 |
| serious Total, serious adverse events | 0 / 41 |
Outcome results
Primary
Number of Subjects That Showed no Significant Irritation
Score of less than or equal to 1.2 on the Cumulative Irritation Test scale (0-5).
Time frame: 14 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Healthy Subject | Number of Subjects That Showed no Significant Irritation | 0 participants |