Back to resultsHealing Effects of HP802-247 Versus Antibiotic Ointment in Mohs Micrographic Surgery Patients
Primary Purpose
Non-melanoma Skin Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
HP802-247
Bacitracin Ointment
Sponsored by
About this trial
This is an interventional treatment trial for Non-melanoma Skin Cancer focused on measuring Wound, non-melanoma skin cancer, Mohs micrographic surgery, Head or neck
Eligibility Criteria
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.
Sites / Locations
- Derm Research PLC
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
HP802-247
Bacitracin Ointment
Arm Description
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 antibiotic ointment
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
The Number of Subjects With Complete Wound Closure at Each Evaluation Visit.
Complete wound closure was assessed at each evaluation visit.
Time in Days to Wound Closure
The Kaplan-Meier survival analysis was used to calculate the mean time in days to complete wound closure.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01359735
Brief Title
Healing Effects of HP802-247 Versus Antibiotic Ointment in Mohs Micrographic Surgery Patients
Official Title
A Phase II Randomized, Open-label Study Investigating the Healing Effects of HP802-247 Versus Antibiotic Ointment in Mohs Micrographic Surgery Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Healthpoint
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study compares HP802-247 versus an antibiotic ointment for healing the wound after Mohs surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-melanoma Skin Cancer
Keywords
Wound, non-melanoma skin cancer, Mohs micrographic surgery, Head or neck
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HP802-247
Arm Type
Active Comparator
Arm Description
allogeneic, growth arrested keratinocytes and fibroblasts: final concentration of 5.0 M cells/mL with a ratio of 1:9 keratinocytes:fibroblasts, applied weekly
Arm Title
Bacitracin Ointment
Arm Type
Active Comparator
Arm Description
bacitracin antibiotic ointment
Intervention Type
Biological
Intervention Name(s)
HP802-247
Intervention Description
High dose HP 802-247, applied at each visit (Week 1-13) or until healed
Intervention Type
Biological
Intervention Name(s)
Bacitracin Ointment
Intervention Description
One dose of Bacitracin ointment consists of 50 units/1 gram. This will be applied daily for 12 weeks (or until healed).
Primary Outcome Measure Information:
Title
The Primary Efficacy Measure Was the Investigator's Global Assessment of Healing (IGAH).
Description
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
Secondary Outcome Measure Information:
Title
The Number of Subjects With Complete Wound Closure at Each Evaluation Visit.
Description
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
Title
Time in Days to Wound Closure
Description
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
Title
Investigator Reported Signs and Symptoms
Description
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.
Title
Subject Reported Signs and Symptoms
Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Herbert B Slade, MD
Organizational Affiliation
Healthpoint
Official's Role
Study Chair
Facility Information:
Facility Name
Derm Research PLC
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Healing Effects of HP802-247 Versus Antibiotic Ointment in Mohs Micrographic Surgery Patients
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