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The product is being tested to see if exposure to light causes photoallergic reactions on the skin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xenaderm | Experimental | Subject serves as own control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ointment Vehicle | Other | Subject acts as own control. 20 mg under Finn chambers |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency Distribution of Skin Irritation Scores | Scores based on skin irritation scale of 0 (no reaction) to 7 (large vesiculo-bullous reaction) in whole units. Photoallergic reactions were characterized by irritation scores of 3 or higher. | 48-hours post irradiation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joe Stanfield, PhD | Suncare Research Laboratories | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Suncare Research Laboratories | Winston-Salem | North Carolina | United States |
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Planned: Approximately 60 evaluable subjects. Analyzed: 59 subjects were enrolled in the study, of which 58 were randomized and received test article. 7 subjects were prematurely withdrawn - 1 prior to receiving test articles; 52 subjects completed the study and were evaluable.
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| ID | Title | Description |
|---|---|---|
| FG000 | Xenaderm | Subject serves as own control |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Xenaderm | Subject serves as own control |
| 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 | Frequency Distribution of Skin Irritation Scores | Scores based on skin irritation scale of 0 (no reaction) to 7 (large vesiculo-bullous reaction) in whole units. Photoallergic reactions were characterized by irritation scores of 3 or higher. | Analysis was based on number of subjects who completed the study. | Posted | Number | Scores on a scale | 48-hours post irradiation |
|
|
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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 | Xenaderm | Subject serves as own control |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Burning at test site | General disorders | MedDRA 10.0 | Non-systematic Assessment |
Interpretation of frequency distribution of skin irritation scores was based on long term experience with this type of testing.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Herbert B. Slade MD, FAAAAI | DFB Pharmaceuticals | 817.302.3919 | bert.slade@dfbpharmaceuticals.com |
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| ID | Term |
|---|---|
| D009824 | Ointments |
| C062801 | Granulex |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| Xenaderm |
| Drug |
20 mg under Finn chambers |
|
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 0 |
| 59 |
| 25 |
| Itching at test site | General disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Fever | General disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Tape reaction | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
|
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