Healing Effects of HP802-247 Versus Antibiotic Ointment in Mohs Micrographic Surgery Patients
Information source: Healthpoint
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Non-melanoma Skin Cancer
Intervention: HP802-247 (Biological); Bacitracin Ointment (Biological)
Phase: Phase 2
Status: Completed
Sponsored by: Healthpoint Official(s) and/or principal investigator(s):
Herbert B Slade, MD, Study Chair, Affiliation: Healthpoint
Summary
This study compares HP802-247 versus an antibiotic ointment for healing the wound after Mohs
surgery.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Investigator Global Assessment of Healing
Secondary outcome: Adverse events
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Derm Research PLC, Louisville, Kentucky 40217, United States
Additional Information
Starting date: May 2011
Last updated: September 19, 2013
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