Healing Effects of HP802-247 Versus Antibiotic Ointment in Mohs Micrographic Surgery Patients

Study Overview
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Brief Summary
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This study compares HP802-247 versus an antibiotic ointment for healing the wound after Mohs surgery.

Official Title
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A Phase II Randomized, Open-label Study Investigating the Healing Effects of HP802-247 Versus Antibiotic Ointment in Mohs Micrographic Surgery Patients

Conditions
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Non-melanoma Skin Cancer

Intervention / Treatment
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* Biological: HP802-247
* Biological: Bacitracin Ointment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HP802-247<br>allogeneic, growth arrested keratinocytes and fibroblasts: final concentration of 5.0 M cells/mL with a ratio of 1:9 keratinocytes:fibroblasts, applied weekly | Biological: HP802-247<br>* High dose HP 802-247, applied at each visit (Week 1-13) or until healed<br>|
| Active Comparator: Bacitracin Ointment<br>bacitracin antibiotic ointment | Biological: Bacitracin Ointment<br>* One dose of Bacitracin ointment consists of 50 units/1 gram. This will be applied daily for 12 weeks (or until healed).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wound, non-melanoma skin cancer, Mohs micrographic surgery, Head or neck