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The objective of the study is to compare the healing of wounds induced by cryo-injury when treated with white petrolatum versus an ointment vehicle.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Other | Xenaderm Vehicle |
|
| 2 | Placebo Comparator | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xenaderm Vehicle | Drug | Ointment to be applied three times a day on cryo-surgery wound for 21 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete Wound Closure | Each subject acting as their own control | 21 Days |
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Inclusion Criteria:
Subjects will be considered qualified for enrollment if they:
Exclusion Criteria:
Subjects will be considered NOT qualified for enrollment if they:
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| Name | Affiliation | Role |
|---|---|---|
| Herbert R Slade, MD | Healthpoint | Study Chair |
| D. Innes Cargill, PhD | Healthpoint | Study Director |
| Steven R Feldman, MD, PhD | Wake Forest | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Dermatology, Wake Forrest School of Medicine | Winston-Salem | North Carolina | 27157 | United States |
Each subject acting as their own control
Healthy adult volunteers, 18 years of age and older
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| ID | Title | Description |
|---|---|---|
| FG000 | Vehicle vs. Placebo | Xenaderm Vehicle and White Petrolatum as Placebo Comparator Xenaderm Vehicle : Ointment to be applied three times a day on cryo-surgery wound for 21 days. White Petrolatum : Ointment to be applied three times a day on cryo-surgery wound for 21 days Each subject acting as their own control |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vehicle vs. Placebo | Xenaderm Vehicle and White Petrolatum as Placebo Comparator Xenaderm Vehicle : Ointment to be applied three times a day on cryo-surgery wound for 21 days. White Petrolatum : Ointment to be applied three times a day on cryo-surgery wound for 21 days Each subject acting as their 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 | Complete Wound Closure | Each subject acting as their own control | Posted | Mean | Standard Deviation | days | 21 Days |
|
|
21 days
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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 | Vehicle | Xenaderm Ointment Vehicle : each subject acting as their own control |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment | Most frequently reported adverse events were in the skin and subcutaneous disorders group; most frequently reported were due to reactions to adhesive of the band-aid: erythema, itching, bleeding, burning; all were assessed unrelated to test articles. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jaime Dickerson, PhD | Smith & Nephew Biotherapeutics | 817-302-3914 | jaime.dickerson@smith-nephew.com |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| C062801 | Granulex |
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| Placebo comparator | Other | Ointment to be applied three times a day on cryo-surgery wound for 21 days. |
|
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| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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|
|
| 0 |
| 25 |
| 6 |
| 25 |
| EG001 | Placebo Control | White Petrolatum : each subject acting as their own control | 0 | 25 | 6 | 25 |
|
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