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

This study has been completed.
Information provided by (Responsible Party):
Healthpoint Identifier:
First received: May 23, 2011
Last updated: May 31, 2017
Last verified: May 2017
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
Intervention Model: Parallel Assignment
Masking: None (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:
  • The Primary Efficacy Measure Was the Investigator's Global Assessment of Healing (IGAH). [ Time Frame: 13 weeks- The IGAH was measured at study Weeks 4 and 13 ]
    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.

Secondary Outcome Measures:
  • The Number of Subjects With Complete Wound Closure at Each Evaluation Visit. [ Time Frame: Over 12 weeks or until wound closure, which ever occurred first. Following completion of treatment subjects were followed for a further 4 weeks ]
    Complete wound closure was assessed at each evaluation visit.

  • Time in Days to Wound Closure [ Time Frame: Over the 12 week treatment period ]
    The Kaplan-Meier survival analysis was used to calculate the mean time in days to complete wound closure.

  • Investigator Reported Signs and Symptoms [ Time Frame: At each evaluation visit: Weeks 3 and 12 post-surgery. ]
    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.

  • Subject Reported Signs and Symptoms [ Time Frame: At each evaluation visit: Weeks 3, and 12 post-surgery. ]
    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.

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   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Please refer to this study by its 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

Responsible Party: Healthpoint Identifier: NCT01359735     History of Changes
Other Study ID Numbers: 802-247-09-022
Study First Received: May 23, 2011
Results First Received: September 13, 2016
Last Updated: May 31, 2017

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

Additional relevant MeSH terms:
Skin Neoplasms
Neoplasms by Site
Skin Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Anti-Infective Agents, Local processed this record on September 21, 2017