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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Healthpoint
ClinicalTrials.gov Identifier:
NCT01359735
First received: May 23, 2011
Last updated: May 31, 2017
Last verified: May 2017
  Purpose
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).

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Responsible Party: Healthpoint
ClinicalTrials.gov 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:
Wound
non-melanoma skin cancer
Mohs micrographic surgery
Head or neck

Additional relevant MeSH terms:
Skin Neoplasms
Neoplasms by Site
Neoplasms
Skin Diseases
Anti-Bacterial Agents
Bacitracin
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Anti-Infective Agents, Local

ClinicalTrials.gov processed this record on September 21, 2017