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This study compares HP802-247 versus an antibiotic ointment for healing the wound after Mohs surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HP802-247 | Active Comparator | allogeneic, growth arrested keratinocytes and fibroblasts: final concentration of 5.0 M cells/mL with a ratio of 1:9 keratinocytes:fibroblasts, applied weekly |
|
| Bacitracin Ointment | Active Comparator | bacitracin antibiotic ointment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HP802-247 | Biological | High dose HP 802-247, applied at each visit (Week 1-13) or until healed |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Primary Efficacy Measure Was the Investigator's Global Assessment of Healing (IGAH). | The IGAH is a four-point scale based on the following assessment scores: 0 = not effective, 1 = slightly effective, 2 = moderately effective, 3 = very effective. The descriptive statistics for both a continuous variable and a categorical variable were summarized for IGAH by treatment week and treatment endpoint. The Wilcoxon rank-sum test was used to test the difference in IGAH score between HP802-247 and bacitracin ointment for each treatment week and treatment endpoint. Since this was a small and exploratory study, the P-value of a 1-sided test was reported. | 13 weeks- The IGAH was measured at study Weeks 4 and 13 |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Subjects With Complete Wound Closure at Each Evaluation Visit. | Complete wound closure was assessed at each evaluation visit. | Over 12 weeks or until wound closure, which ever occurred first. Following completion of treatment subjects were followed for a further 4 weeks |
| Time in Days to Wound Closure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Herbert B Slade, MD | Healthpoint | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Derm Research PLC | Louisville | Kentucky | 40217 | United States |
Subjects who met inclusion criteria returned for visit1 on the day of surgery and entered the study following. Subjects randomly assigned to HP802-247 or Bacitracin for post-surgical treatment, which lasted for up to 12 weeks or wound closure, which ever occurred first. Following completion of treatment subjects were followed for 4 weeks
Subjects were enrolled at a single US investigational site, between June 22, 2011and November 16, 2011
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| ID | Title | Description |
|---|---|---|
| FG000 | HP802-247 | allogeneic, growth arrested keratinocytes and fibroblasts: final concentration of 5.0 M cells/mL with a ratio of 1:9 keratinocytes:fibroblasts, applied weekly HP802-247: High dose HP 802-247, applied at each visit (Week 1-13) or until healed |
| FG001 | Bacitracin Ointment | bacitracin antibiotic ointment Bacitracin Ointment: One dose of Bacitracin ointment consists of 50 units/1 gram. This will be applied daily for 12 weeks (or until healed). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | HP802-247 | allogeneic, growth arrested keratinocytes and fibroblasts: final concentration of 5.0 M cells/mL with a ratio of 1:9 keratinocytes:fibroblasts, applied weekly HP802-247: High dose HP 802-247, applied at each visit (Week 1-13) or until healed |
| BG001 | Bacitracin Ointment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | The Primary Efficacy Measure Was the Investigator's Global Assessment of Healing (IGAH). | The IGAH is a four-point scale based on the following assessment scores: 0 = not effective, 1 = slightly effective, 2 = moderately effective, 3 = very effective. The descriptive statistics for both a continuous variable and a categorical variable were summarized for IGAH by treatment week and treatment endpoint. The Wilcoxon rank-sum test was used to test the difference in IGAH score between HP802-247 and bacitracin ointment for each treatment week and treatment endpoint. Since this was a small and exploratory study, the P-value of a 1-sided test was reported. | The ITT population - all subjects who underwent MMS. | Posted | Mean | Standard Deviation | units on a scale | 13 weeks- The IGAH was measured at study Weeks 4 and 13 |
|
Safety reporting occurred over the eight weeks of the study.
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
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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 | HP802-247 | allogeneic, growth arrested keratinocytes and fibroblasts: final concentration of 5.0 M cells/mL with a ratio of 1:9 keratinocytes:fibroblasts, applied weekly HP802-247: High dose HP 802-247, applied at each visit (Week 1-13) or until healed |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA v 12.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jaime E Dickerson, PhD | Smith & Nephew | 1-817-302-3914 | Jaime.Dickerson@smith-nephew.com |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| Bacitracin Ointment | Biological | One dose of Bacitracin ointment consists of 50 units/1 gram. This will be applied daily for 12 weeks (or until healed). |
|
The Kaplan-Meier survival analysis was used to calculate the mean time in days to complete wound closure. |
| Over the 12 week treatment period |
| Investigator Reported Signs and Symptoms | Investigator reported signs and/or symptoms, based on the following 12 items, each scored as none (=0), mild (=1), moderate (=2), or severe (=3): Erythema, Erosion, Ulceration, Swelling, Scarring, Infection, Crusting, Necrosis, Peeling, Contact Dermatitis, Hyper/Hypopigmentation. Item scores were averaged. | At each evaluation visit: Weeks 3 and 12 post-surgery. |
| Subject Reported Signs and Symptoms | Subjects reported signs or symptoms, based on the following 6 items, each scored as none (=0), mild (=1), moderate (=2), or severe (=3): irritation, itchiness, burning, tenderness, pain, and stinging. Item scores were averaged. | At each evaluation visit: Weeks 3, and 12 post-surgery. |
bacitracin antibiotic ointment Bacitracin Ointment: One dose of Bacitracin ointment consists of 50 units/1 gram. This will be applied daily for 12 weeks (or until healed). |
| BG002 | Total | Total of all reporting groups |
| years |
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| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Bacitracin Ointment | bacitracin antibiotic ointment Bacitracin Ointment: One dose of Bacitracin ointment consists of 50 units/1 gram. This will be applied daily for 12 weeks (or until healed). |
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|
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| Secondary | The Number of Subjects With Complete Wound Closure at Each Evaluation Visit. | Complete wound closure was assessed at each evaluation visit. | The ITT population - all subjects who underwent MMS. Fisher's exact test was used to examine the difference in proportion of subjects with complete wound closure at each of the corresponding time points between the two treatment groups, and the P-value of a 1-sided test was reported. | Posted | Number | participants | Over 12 weeks or until wound closure, which ever occurred first. Following completion of treatment subjects were followed for a further 4 weeks |
|
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|
|
| Secondary | Time in Days to Wound Closure | The Kaplan-Meier survival analysis was used to calculate the mean time in days to complete wound closure. | The ITT population - all subjects who underwent MMS. The Log-rank test was used to test for an inter-group difference. | Posted | Mean | Standard Deviation | Days | Over the 12 week treatment period |
|
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|
|
| Secondary | Investigator Reported Signs and Symptoms | Investigator reported signs and/or symptoms, based on the following 12 items, each scored as none (=0), mild (=1), moderate (=2), or severe (=3): Erythema, Erosion, Ulceration, Swelling, Scarring, Infection, Crusting, Necrosis, Peeling, Contact Dermatitis, Hyper/Hypopigmentation. Item scores were averaged. | The ITT population-all subjects who underwent MMS. Both total score and individual item score of the two signs and symptoms rating scales summarized descriptively at Weeks 4, 7, and 13 as well as at the treatment endpoint and compared using a two-sample t-test. the P-value of a 1-sided test was reported. | Posted | Mean | Standard Deviation | units on a scale | At each evaluation visit: Weeks 3 and 12 post-surgery. |
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|
| Secondary | Subject Reported Signs and Symptoms | Subjects reported signs or symptoms, based on the following 6 items, each scored as none (=0), mild (=1), moderate (=2), or severe (=3): irritation, itchiness, burning, tenderness, pain, and stinging. Item scores were averaged. | The ITT population - all subjects who underwent MMS. Both the total score and individual item score of the two signs and symptoms rating scales were summarized descriptively at Weeks 4, 7, and 13 as well as at the treatment endpoint and compared using a two-sample t-test, and the P-value of a 1-sided test was reported. | Posted | Mean | Standard Deviation | units on a scale | At each evaluation visit: Weeks 3, and 12 post-surgery. |
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| 0 |
| 4 |
| 2 |
| 4 |
| EG001 | Bacitracin Ointment | bacitracin antibiotic ointment Bacitracin Ointment: One dose of Bacitracin ointment consists of 50 units/1 gram. This will be applied daily for 12 weeks (or until healed). | 0 | 4 | 3 | 4 |
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA v 12.0 | Systematic Assessment |
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| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v 12.0 | Systematic Assessment |
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| Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v 12.0 | Systematic Assessment |
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| Seborrhoeic keratosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v 12.0 | Systematic Assessment |
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| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v 12.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA v 12.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA v 12.0 | Systematic Assessment |
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| Week 03 |
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| Week 04 |
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| Week 13 |
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| Week 17/Exit |
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12 Weeks |
| 2-Sided |
| Superiority or Other |
Week 12 Post-surgery |
| 2-Sided |
| Superiority or Other |