Edema, Erythema
Conditions
Brief summary
The purpose of this test is to evaluate the sensitizing potential of a personal lubricant, as a result of repeated occlusive patch. The intervention will be applied for a total of 9 induction applications, followed by an approximately 2 week rest period, then followed by a 24-72 hour Challenge applications.
Interventions
DEVICEChameleon Personal Lubricant
Sponsors
Church & Dwight Company, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Masking description
All participants receive the same interventions
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
Yes
Inclusion criteria
* good health as determined from screener * signed and dated informed consent * signed and dated HIPAA Form
Exclusion criteria
* subjects on test at any other research laboratory or clinic * known allergy or sensitivity to cosmetics and toiletries, including sunscreens, adhesives and/or topical drugs * pre-existing dermatologic conditions which have been diagnosed by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study * pre-existing other medical conditions (e.g. adult asthma, diabetes). * treatment with antibiotics, antihistamines or corticosteroids within two weeks prior to initiation of the test * chronic medication which could affect the results of the study (e.g., insulin, corticosteroids, antihistimines, steroidal or non-steroidal anti-inflammatory drugs \[except for therapeutic maintenance dosage of aspirin\], antibiotics, steroid inhalers, etc.) * known pregnant or nursing women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Patients That Showed Sensitization Reaction to the Test Material at Challenge | 24, 48 and 72 hours after patch application |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Healthy Subject Healthy subjects exposed to Trojan Chameleon personal lubricant via occlusive patch
Trojan Chameleon Personal Lubricant | 222 |
| Total | 222 |
Baseline characteristics
| Characteristic | Healthy Subject | — |
|---|---|---|
| Age, Customized 18-69 years | 222 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 150 Participants | — |
| Sex: Female, Male Male | 72 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 222 |
| serious Total, serious adverse events | 0 / 222 |
Outcome results
Primary
Number of Patients That Showed Sensitization Reaction to the Test Material at Challenge
Time frame: 24, 48 and 72 hours after patch application
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Healthy Subject | Number of Patients That Showed Sensitization Reaction to the Test Material at Challenge | 0 Participants |