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| ID | Type | Description | Link |
|---|---|---|---|
| 31335 | Other Identifier | WakeForest |
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The purpose of this research study is to evaluate the use of Biafine Cream on wounds created by removal of actinic keratosis using cryotherapy in a clinical setting.
Subjects were randomized to apply Biafine® to wounds on one forearm and polysporin (standard of care) to wounds on the other. Medications were applied three times a day for 4 weeks to the areas that have been treated with cryotherapy at the baseline visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biafin on left arm | Experimental | Subjects were randomized to apply Biafine® to wounds on the left forearm and polysporin (standard of care) to wounds on the right forearm. Medications were applied three times a day for 4 weeks to the areas that have been treated with liquid nitrogen at the baseline visit. |
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| Biafin on right arm | Experimental | Subjects were randomized to apply Biafine to wounds on the right forearm and Polysporin to wounds on the left forearm. Medications were applied three times a day for 4 weeks to the areas that have been treated with liquid nitrogen at the baseline visit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biafine | Drug | Apply to wounds 3 times daily for 4 weeks: ingredients: purified water, liquid paraffin, glycol monostearate, stearic acid, propylene glycol, paraffin wax, squalene, avocado oil, trolamine sodium alginate, cetyl palmitate, methylparaben, sorbic acid, propyl paraben and fragrance. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Severity Score | The change in the Mean Severity Score from Baseline to Week 4 (or end of treatment) as measured by the Mean Combined Severity Scores for Erythema, Scab, and Thickness on a scale of 0-4 with 0=None 1=slight 2=mild 3= moderate 4= severe | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steve Feldman, MD, PhD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences Dermatology | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Biafin on Left | Subjects were randomized to apply Biafine® to wounds on the left forearm and polysporin (standard of care) to wounds on the right forearm. Medications were applied three times a day for 4 weeks to the areas that have been treated with liquid nitrogen at the baseline visit. Biafine: Apply to wounds 3 times daily for 4 weeks: ingredients: purified water, liquid paraffin, glycol monostearate, stearic acid, propylene glycol, paraffin wax, squalene, avocado oil, trolamine sodium alginate, cetyl palmitate, methylparaben, sorbic acid, propyl paraben and fragrance. Polysporin: over the counter Polysporin ointment 3 times daily for 4 weeks to wounds |
| FG001 | Biafin on Right | Subjects were randomized to apply Biafine® to wounds on the right forearm and polysporin (standard of care) to wounds on the left forearm. Medications were applied three times a day for 4 weeks to the areas that have been treated with liquid nitrogen at the baseline visit. Biafine: Apply to wounds 3 times daily for 4 weeks: ingredients: purified water, liquid paraffin, glycol monostearate, stearic acid, propylene glycol, paraffin wax, squalene, avocado oil, trolamine sodium alginate, cetyl palmitate, methylparaben, sorbic acid, propyl paraben and fragrance. Polysporin: over the counter Polysporin ointment 3 times daily for 4 weeks to wounds |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Biafin on Left | Subjects were randomized to apply Biafine® to wounds on the left forearm and polysporin (standard of care) to wounds on the right forearm. Medications were applied three times a day for 4 weeks to the areas that have been treated with liquid nitrogen at the baseline visit. Biafine: Apply to wounds 3 times daily for 4 weeks: ingredients: purified water, liquid paraffin, glycol monostearate, stearic acid, propylene glycol, paraffin wax, squalene, avocado oil, trolamine sodium alginate, cetyl palmitate, methylparaben, sorbic acid, propyl paraben and fragrance. Polysporin: over the counter Polysporin ointment 3 times daily for 4 weeks to wounds |
| 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 | Mean Severity Score | The change in the Mean Severity Score from Baseline to Week 4 (or end of treatment) as measured by the Mean Combined Severity Scores for Erythema, Scab, and Thickness on a scale of 0-4 with 0=None 1=slight 2=mild 3= moderate 4= severe | Posted | Mean | Standard Deviation | units on a scale | 4 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 | Biafin Treatment Group | Experimental: Biafine Treatment Group This group includes the forearm of the subjects that was randomized to apply Biafine® to wounds (either the left forearm or right forearm). Biafine was applied three times a day for 4 weeks to the areas that have been treated with liquid nitrogen at the baseline visit. Drug: Biafine Apply to wounds 3 times daily for 4 weeks: ingredients: purified water, liquid paraffin, glycol monostearate, stearic acid, propylene glycol, paraffin wax, squalene, avocado oil, trolamine sodium alginate, cetyl palmitate, methylparaben, sorbic acid, propyl paraben and fragrance. Other Names: • Biafine |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steve Feldman MD | Wake Forest University Health Sciences | 336-716-3775 | sfeldman@wakehealth.edu |
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| ID | Term |
|---|---|
| D055623 | Keratosis, Actinic |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C423724 | Biafine |
| C069612 | bacitracin, polymyxin B drug combination |
| D001414 | Bacitracin |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
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| Polysporin | Drug | over the counter Polysporin ointment 3 times daily for 4 weeks to wounds |
|
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| BG001 | Biafin on Right | Subjects were randomized to apply Biafine® to wounds on the right forearm and polysporin (standard of care) to wounds on the left forearm. Medications were applied three times a day for 4 weeks to the areas that have been treated with liquid nitrogen at the baseline visit. Biafine: Apply to wounds 3 times daily for 4 weeks: ingredients: purified water, liquid paraffin, glycol monostearate, stearic acid, propylene glycol, paraffin wax, squalene, avocado oil, trolamine sodium alginate, cetyl palmitate, methylparaben, sorbic acid, propyl paraben and fragrance. Polysporin: over the counter Polysporin ointment 3 times daily for 4 weeks to wounds |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Polysporin Treatment Group | This group includes the forearm of the subjects that was randomized to apply Polysporin (standard of care) to wounds (either the left forearm or right forearm). Polysporin was applied three times a day for 4 weeks to the areas that have been treated with liquid nitrogen at the baseline visit. Drug: Polysporin over the counter Polysporin ointment 3 times daily for 4 weeks to wounds Other Names: • Bacitracin |
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|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Polysporin Treatment Group | Active Comparator: Polysporin Treatment Group This group includes the forearm of the subjects that was randomized to apply Polysporin (standard of care) to wounds (either the left forearm or right forearm). Polysporin was applied three times a day for 4 weeks to the areas that have been treated with liquid nitrogen at the baseline visit. Drug: Polysporin over the counter Polysporin ointment 3 times daily for 4 weeks to wounds Other Names: • Bacitracin | 0 | 20 | 0 | 20 | 0 | 20 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D000602 |
| Amino Acids, Peptides, and Proteins |