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

This study has been completed.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: May 23, 2011
Last updated: September 19, 2013
Last verified: September 2013

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

Condition Intervention Phase
Non-melanoma Skin Cancer
Biological: HP802-247
Biological: Bacitracin Ointment
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Randomized, Open-label Study Investigating the Healing Effects of HP802-247 Versus Antibiotic Ointment in Mohs Micrographic Surgery Patients

Resource links provided by NLM:

Further study details as provided by Healthpoint:

Primary Outcome Measures:
  • Investigator Global Assessment of Healing [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events [ Time Frame: 13 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 8
Study Start Date: May 2011
Study Completion Date: May 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: HP802-247
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
High dose HP 802-247, applied at each visit (Week 1-13) or until healed
Active Comparator: Bacitracin Ointment
bacitracin antibiotic ointment
Biological: Bacitracin Ointment
One dose of Bacitracin ointment consists of 50 units/1 gram. This will be applied daily for 12 weeks (or until healed).


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01359735

United States, Kentucky
Derm Research PLC
Louisville, Kentucky, United States, 40217
Sponsors and Collaborators
Study Chair: Herbert B Slade, MD Healthpoint
  More Information

No publications provided

Responsible Party: Healthpoint
ClinicalTrials.gov Identifier: NCT01359735     History of Changes
Other Study ID Numbers: 802-247-09-022
Study First Received: May 23, 2011
Last Updated: September 19, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Healthpoint:
non-melanoma skin cancer
Mohs micrographic surgery
Head or neck

Additional relevant MeSH terms:
Skin Neoplasms
Carcinoma, Basal Cell
Carcinoma, Basosquamous
Carcinoma, Squamous Cell
Neoplasms by Site
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Basal Cell
Neoplasms, Squamous Cell
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Anti-Infective Agents, Local

ClinicalTrials.gov processed this record on April 23, 2014