Dermal Irritation
Conditions
Brief summary
to determine the ability of the test article to cause irritation to the skin of humans under controlled patch test conditions
Interventions
silicone base with sensate
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
* male or female, 18-70 years of age, in general good health * normal skin * 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 * of any skin type or race providing the skin pigmentation will allow discernment of erythema * agree to complete a medical history and concomitant medication form * read, understand and sign 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 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 * have a known sensitivity to cosmetics, skin care test articles, or topical drugs as related to the test article being evaluated * are females who are pregnant or breastfeeding or become pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Subjects That Showed Erythema Based on 5 Point Scoring Scale | 14 days |
| Number of Subjects That Showed Edema Based on the 5 Point Scoring Scale | 14 days |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Healthy Subject Healthy subjects exposed to Trojan Chameleon Personal Lubricant applied by occlusive patch
Trojan Chameleon Personal Lubricant: silicone base with sensate | 34 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 9 |
Baseline characteristics
| Characteristic | Healthy Subject | — |
|---|---|---|
| Age, Customized 18-69 | 34 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 28 Participants | — |
| Sex: Female, Male Male | 6 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 34 |
| serious Total, serious adverse events | 0 / 34 |
Outcome results
Primary
Number of Subjects That Showed Edema Based on the 5 Point Scoring Scale
Time frame: 14 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Healthy Subject | Number of Subjects That Showed Edema Based on the 5 Point Scoring Scale | 0 Participants |
Primary
Number of Subjects That Showed Erythema Based on 5 Point Scoring Scale
Time frame: 14 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Healthy Subject | Number of Subjects That Showed Erythema Based on 5 Point Scoring Scale | 0 Participants |