Allergic Sensitization
Conditions
Brief summary
Patch Testing for device cream on human subjects
Interventions
DEVICELight Therapy Mask Cream
test panel
Sponsors
Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Male or Female * 18+ years * Good health * Signed and datad Informed Consent * Signed and dated HIPAA
Exclusion criteria
* On test at any other research lab or clinic * Known allergy or sensitivity to cosmetics or toiletries * Pre-existing other medical conditions * Treatment with antibiotics, antihistamines, or corticosteroids within 2 weeks of the test * Chronic medication which could affect the outcome of the study * Known pregnant or nursing women * Cancer diagnosis within the past 5 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants That Did Not Have Test Material Induced Clinically Significant Dermal Irritation | approximately 6 weeks | Clinically Significant Dermal Irritation refers to an overall outcome measure in which, after 6 weeks of the test (patching the skin (3 weeks) & then challenging the skin (at week 6)), the test product caused a clinically significant dermal reaction (scores of 2 or greater). Participant scores less than 2 are not considered to be Clinically significant. Scoring System: 0 = No visible reaction ± = Faint, minimal erythema 1. = Erythema 2. = Intense erythema 3. = Intense erythema, induration, vesicles 4. = Severe reaction with erythema, induration, vesicles, pustules (may be weeping) E = Edema DR = Dryness P = Peeling S = Staining * = Hyperpigmentation / Hypopigmentation C = Change of test site N9R = No 9th reading * = No patch application and / or reading TR = Tape Reaction |
Countries
United States
Participant flow
Pre-assignment details
There were 121 subjects enrolled. 3 of those subjects were disconinued prior to being patched due to screen failure. Therefore, 118 subjects started using patches.
Participants by arm
| Arm | Count |
|---|---|
| Test Panel Light Therapy Mask Cream | 110 |
| Total | 110 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 8 |
Baseline characteristics
| Characteristic | Test Panel | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 5 Participants | — |
| Age, Categorical Between 18 and 65 years | 105 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 83 Participants | — |
| Sex: Female, Male Male | 27 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 118 |
| other Total, other adverse events | 0 / 118 |
| serious Total, serious adverse events | 0 / 118 |
Outcome results
Primary
Number of Participants That Did Not Have Test Material Induced Clinically Significant Dermal Irritation
Clinically Significant Dermal Irritation refers to an overall outcome measure in which, after 6 weeks of the test (patching the skin (3 weeks) & then challenging the skin (at week 6)), the test product caused a clinically significant dermal reaction (scores of 2 or greater). Participant scores less than 2 are not considered to be Clinically significant. Scoring System: 0 = No visible reaction ± = Faint, minimal erythema 1. = Erythema 2. = Intense erythema 3. = Intense erythema, induration, vesicles 4. = Severe reaction with erythema, induration, vesicles, pustules (may be weeping) E = Edema DR = Dryness P = Peeling S = Staining * = Hyperpigmentation / Hypopigmentation C = Change of test site N9R = No 9th reading * = No patch application and / or reading TR = Tape Reaction
Time frame: approximately 6 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Test Panel | Number of Participants That Did Not Have Test Material Induced Clinically Significant Dermal Irritation | 110 Participants |