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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


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


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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


- 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

Page last updated: August 20, 2015

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