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The product is being tested to see if exposure to light causes toxic reactions on the skin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Drug |
|
| B | Placebo Comparator | Placebo comparator |
|
| C | No Intervention | Subjects serve as own controls. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xenaderm | Drug | 20mg under Finn chambers |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Skin Reaction Score | Scores for phototoxic skin irritation were used to evaluate safety. In this study, irritation was graded using a scale that ranged from 0 (no reaction) to 7 (large vesiculo-bullous reaction) in whole units. | 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Innes Cargill, PhD | Healthpoint, Ltd. | Study Director |
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This phase 1 study was conducted at one investigational site (Research Laboratory) located in the US, and conducted on healthy adult subjects of either gender, and skin-type I, II, or III, who were 18 years of age and older, from 19-Feb-2008 to 29-Feb-2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Xenaderm Ointment - Subjects Acted as Own Comparator | Two 20 mg samples of Xenaderm Ointment and two 20 mg samples of Vehicle were applied in Finn Chambers to four test sites of the left side of each subject's back; a fifth test site was covered with an empty Finn Chamber as a control site |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Xenaderm vs. Vehicle - Subjects Acted as Own Comparator | Subjects received duplicate 20 mg applications of Xenaderm Ointment and Xenaderm vehicle contained in Finn Chambers, to the left sides of their backs |
| 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 | Skin Reaction Score | Scores for phototoxic skin irritation were used to evaluate safety. In this study, irritation was graded using a scale that ranged from 0 (no reaction) to 7 (large vesiculo-bullous reaction) in whole units. | Intent-to-Treat (ITT) | Posted | Mean | Standard Deviation | units on a scale | 48 hours |
|
All subjects were exposed to Xenaderm Ointment and Xenaderm vehicle at Day 1. The exposures were occluded under Finn Chambers for 24 hours.
Tabulations of adverse events were used to qualitatively summarize the events by description, severity, and causality. The tabulations were reviewed for evidence of safety trends unrelated to the phototoxicity assessments.
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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 Ointment - Subjects Acted as Own Comparator | Two 20 mg samples of Xenaderm Ointment and two 20 mg samples of Vehicle were applied in Finn Chambers to four test sites of the left side of each subject's back; a fifth test site was covered with an empty Finn Chamber as a control site |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin Irritation | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment | Tape Irritation |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jaime E Dickerson, Jr, PhD | Smith & Nephew Biotherapeutics | 817-302-3914 | jaime.dickerson@smith-nephew.com |
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| ID | Term |
|---|---|
| D017484 | Dermatitis, Phototoxic |
| ID | Term |
|---|---|
| D017453 | Dermatitis, Irritant |
| D003877 | Dermatitis, Contact |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C062801 | Granulex |
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| Drug |
20mg under Finn chambers |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Control - Irradiated | test site was covered with an empty Finn Chamber as a control site - then irradiated |
| OG003 | Xenaderm Ointment - Non-irradiated | 20 mg samples of Xenaderm Ointment applied in a Finn Chambers to test site the left side of each subject's back - not irradiated |
| OG004 | Xenaderm Vehicle - Non-irradiated | 20 mg samples of Xenaderm Vehicle applied in a Finn Chambers to test site the left side of each subject's back - not irradiated |
|
|
| 0 |
| 36 |
| 3 |
| 36 |
|
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| D017437 |
| Skin and Connective Tissue Diseases |
| D010787 | Photosensitivity Disorders |
| D017443 | Skin Diseases, Eczematous |