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: September 19, 2013
Last verified: September 2013

May 23, 2011
September 19, 2013
May 2011
November 2011   (final data collection date for primary outcome measure)
Investigator Global Assessment of Healing [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01359735 on ClinicalTrials.gov Archive Site
Adverse events [ Time Frame: 13 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Healing Effects of HP802-247 Versus Antibiotic Ointment in Mohs Micrographic Surgery Patients
A Phase II Randomized, Open-label Study Investigating the Healing Effects of HP802-247 Versus Antibiotic Ointment in Mohs Micrographic Surgery Patients

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-melanoma Skin Cancer
  • Biological: HP802-247
    High dose HP 802-247, applied at each visit (Week 1-13) or until healed
  • 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).
  • 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
    Intervention: Biological: HP802-247
  • Active Comparator: Bacitracin Ointment
    bacitracin antibiotic ointment
    Intervention: Biological: Bacitracin Ointment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
May 2012
November 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01359735
802-247-09-022
No
Healthpoint
Healthpoint
Not Provided
Study Chair: Herbert B Slade, MD Healthpoint
Healthpoint
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP