Phase 2
N=8
Healing Effects of HP802-247 Versus Antibiotic Ointment in Mohs Micrographic Surgery Patients
Non-melanoma Skin Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01359735 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcome: Primary: The Primary Efficacy Measure Was the Investigator's Global Assessment of Healing (IGAH). — 2.75; 2.25; 3.00; 3.00 units on a scale — p=0.263
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- HP802-247 (Biological); Bacitracin Ointment (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Healthpoint
- Primary completion
- Nov 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Primary Efficacy Measure Was the Investigator's Global Assessment of Healing (IGAH). |
2.75; 2.25; 3.00; 3.00 | 0.263 |
| SECONDARY The Number of Subjects With Complete Wound Closure at Each Evaluation Visit. |
0; 0; 0; 0; 0; 0 | 0.5 |
| SECONDARY Time in Days to Wound Closure |
24.8; 28.0 | 0.0594 |
| SECONDARY Investigator Reported Signs and Symptoms |
1.75; 3; 1.00; 1.00 | 0.1354 |
| SECONDARY Subject Reported Signs and Symptoms |
0; 0.75; 0.25; 0 | 0.0841 |
Summary
This study compares HP802-247 versus an antibiotic ointment for healing the wound after Mohs surgery.
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.
Data sourced from ClinicalTrials.gov (NCT01359735). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.