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Patch Testing for device cream on human subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Panel | Experimental | Light Therapy Mask Cream |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Light Therapy Mask Cream | Device | test panel |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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
| approximately 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harrison Research Laboratories | Union | New Jersey | 07083 | United States |
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Panel | Light Therapy Mask Cream |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Only subjects that completed the study per protocol were included in the analysis
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| ID | Title | Description |
|---|---|---|
| BG000 | Test Panel | Light Therapy Mask Cream |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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
| Posted | Count of Participants | Participants | approximately 6 weeks |
|
6 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Test Panel | Light Therapy Mask Cream | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Heather Smith | Johnson & Johnson Consumer Inc. | 908-874-1235 | HSmith21@its.jnj.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 30, 2017 | Jan 30, 2019 | Prot_000.pdf |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
Light Therapy Mask Cream
|
|
| 118 |
| 0 |
| 118 |
| 0 |
| 118 |
The Principal Investigator (PI) will provide Sponsor with at least sixty (60) days to review any Publication. No Publication that incorporates Sponsor Confidential Information will be submitted for publication without Sponsor's prior written consent. If requested in writing, the PI withholds such Publication for up to an additional sixty (60) days to allow for filing of a patent application.