Non-melanoma Skin Cancer
Conditions
Keywords
Wound, non-melanoma skin cancer, Mohs micrographic surgery, Head or neck
Brief summary
This study compares HP802-247 versus an antibiotic ointment for healing the wound after Mohs surgery.
Interventions
BIOLOGICALHP802-247
High dose HP 802-247, applied at each visit (Week 1-13) or until healed
BIOLOGICALBacitracin Ointment
One dose of Bacitracin ointment consists of 50 units/1 gram. This will be applied daily for 12 weeks (or until healed).
Sponsors
Healthpoint
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Provide informed consent. * Age ≥ 18 years and of either sex. * Type I, II, or III skin as assessed by the Fitzpatrick Scale. * Willing to comply with protocol instructions, including allowing all study assessments. * Scheduled to have head or neck non-melanoma skin cancers removed by Mohs micrographic surgery with final wound size of 8 mm to 20 mm in diameter or with 8 mm to 20 mm long axis if not circular. * Acceptable state of health and nutrition, in the opinion of the Investigator.
Exclusion criteria
* History of anaphylaxis, serum sickness, or erythema multiforme reaction to aprotinin, bovine serum albumin or bovine serum proteins, penicillin, streptomycin, or amphotericin B. * Therapy with blood-thinning agents including aspirin within 14 days of the Baseline Visit (these may be resumed post-surgery). * Subjects with platelet or coagulation disorders. * Therapy with another investigational agent within thirty (30) days of Screening, or during the study. * Current systemic therapy with cytotoxic drugs. * Current therapy with chronic (\> 10 days) oral corticosteroids. * In the opinion of the Investigator the subject has a current life expectancy of less than 1 year.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Primary Efficacy Measure Was the Investigator's Global Assessment of Healing (IGAH). | 13 weeks- The IGAH was measured at study Weeks 4 and 13 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Subjects With Complete Wound Closure 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 | Complete wound closure was assessed at each evaluation visit. |
| Time in Days to Wound Closure | Over the 12 week treatment period | The Kaplan-Meier survival analysis was used to calculate the mean time in days to complete wound closure. |
| Investigator Reported Signs and Symptoms | At each evaluation visit: Weeks 3 and 12 post-surgery. | 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. |
| Subject Reported Signs and Symptoms | At each evaluation visit: Weeks 3, and 12 post-surgery. | 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. |
Countries
United States
Participant flow
Recruitment details
Subjects were enrolled at a single US investigational site, between June 22, 2011and November 16, 2011
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| 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 | 4 |
| 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). | 4 |
| Total | 8 |
Baseline characteristics
| Characteristic | HP802-247 | Bacitracin Ointment | Total |
|---|---|---|---|
| Age, Continuous | 74 years STANDARD_DEVIATION 11.6 | 66.8 years STANDARD_DEVIATION 10.7 | 70.4 years STANDARD_DEVIATION 11 |
| Age, Customized 50-69 yrs | 2 participants | 2 participants | 4 participants |
| Age, Customized 70+ yrs | 2 participants | 2 participants | 4 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 4 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 4 Participants | 8 Participants |
| Sex: Female, Male Female | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Male | 3 Participants | 4 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 4 | 3 / 4 |
| serious Total, serious adverse events | 0 / 4 | 0 / 4 |
Outcome results
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.
Time frame: 13 weeks- The IGAH was measured at study Weeks 4 and 13
Population: The ITT population - all subjects who underwent MMS.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HP802-247 | The Primary Efficacy Measure Was the Investigator's Global Assessment of Healing (IGAH). | Week 04 | 2.75 units on a scale | Standard Deviation 0.5 |
| HP802-247 | The Primary Efficacy Measure Was the Investigator's Global Assessment of Healing (IGAH). | Week 13 | 3.00 units on a scale | Standard Deviation 0 |
| Bacitracin Ointment | The Primary Efficacy Measure Was the Investigator's Global Assessment of Healing (IGAH). | Week 04 | 2.25 units on a scale | Standard Deviation 0.96 |
| Bacitracin Ointment | The Primary Efficacy Measure Was the Investigator's Global Assessment of Healing (IGAH). | Week 13 | 3.00 units on a scale | Standard Deviation 0 |
p-value: 0.263Wilcoxon (Mann-Whitney)
p-value: 0.5Wilcoxon (Mann-Whitney)
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.
Time frame: At each evaluation visit: Weeks 3 and 12 post-surgery.
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HP802-247 | Investigator Reported Signs and Symptoms | 3 Weeks Post Surgery | 1.75 units on a scale | Standard Deviation 0.96 |
| HP802-247 | Investigator Reported Signs and Symptoms | 12 Weeks Post Surgery | 1.00 units on a scale | Standard Deviation 0.82 |
| Bacitracin Ointment | Investigator Reported Signs and Symptoms | 3 Weeks Post Surgery | 3 units on a scale | Standard Deviation 1.83 |
| Bacitracin Ointment | Investigator Reported Signs and Symptoms | 12 Weeks Post Surgery | 1.00 units on a scale | Standard Deviation 0.82 |
p-value: 0.1354t-test, 1 sided
p-value: 0.5t-test, 1 sided
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.
Time frame: At each evaluation visit: Weeks 3, and 12 post-surgery.
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HP802-247 | Subject Reported Signs and Symptoms | Week 3 Post-surgery | 0 units on a scale | Standard Deviation 0 |
| HP802-247 | Subject Reported Signs and Symptoms | Week 12 Post-surgery | 0.25 units on a scale | Standard Deviation 0.5 |
| Bacitracin Ointment | Subject Reported Signs and Symptoms | Week 3 Post-surgery | 0.75 units on a scale | Standard Deviation 0.96 |
| Bacitracin Ointment | Subject Reported Signs and Symptoms | Week 12 Post-surgery | 0 units on a scale | Standard Deviation 0 |
p-value: 0.0841t-test, 1 sided
p-value: 0.178t-test, 1 sided
Secondary
The Number of Subjects With Complete Wound Closure at Each Evaluation Visit.
Complete wound closure was assessed at each evaluation visit.
Time frame: Over 12 weeks or until wound closure, which ever occurred first. Following completion of treatment subjects were followed for a further 4 weeks
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HP802-247 | The Number of Subjects With Complete Wound Closure at Each Evaluation Visit. | Week 01 | 0 participants |
| HP802-247 | The Number of Subjects With Complete Wound Closure at Each Evaluation Visit. | Week 02 | 0 participants |
| HP802-247 | The Number of Subjects With Complete Wound Closure at Each Evaluation Visit. | Week 03 | 0 participants |
| HP802-247 | The Number of Subjects With Complete Wound Closure at Each Evaluation Visit. | Week 04 | 3 participants |
| HP802-247 | The Number of Subjects With Complete Wound Closure at Each Evaluation Visit. | Week 13 | 4 participants |
| HP802-247 | The Number of Subjects With Complete Wound Closure at Each Evaluation Visit. | Week 17/Exit | 4 participants |
| Bacitracin Ointment | The Number of Subjects With Complete Wound Closure at Each Evaluation Visit. | Week 13 | 4 participants |
| Bacitracin Ointment | The Number of Subjects With Complete Wound Closure at Each Evaluation Visit. | Week 01 | 0 participants |
| Bacitracin Ointment | The Number of Subjects With Complete Wound Closure at Each Evaluation Visit. | Week 04 | 2 participants |
| Bacitracin Ointment | The Number of Subjects With Complete Wound Closure at Each Evaluation Visit. | Week 02 | 0 participants |
| Bacitracin Ointment | The Number of Subjects With Complete Wound Closure at Each Evaluation Visit. | Week 17/Exit | 4 participants |
| Bacitracin Ointment | The Number of Subjects With Complete Wound Closure at Each Evaluation Visit. | Week 03 | 0 participants |
p-value: 0.5Fisher Exact
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.
Time frame: Over the 12 week treatment period
Population: The ITT population - all subjects who underwent MMS. The Log-rank test was used to test for an inter-group difference.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HP802-247 | Time in Days to Wound Closure | 24.8 Days | Standard Deviation 2.1 |
| Bacitracin Ointment | Time in Days to Wound Closure | 28.0 Days | Standard Deviation 3.5 |
p-value: 0.0594Log Rank