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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
May 23, 2011
May 31, 2017
May 2011
November 2011   (Final data collection date for primary outcome measure)
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.
Investigator Global Assessment of Healing [ Time Frame: 13 weeks ]
Complete list of historical versions of study NCT01359735 on ClinicalTrials.gov Archive Site
  • 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.
Adverse events [ Time Frame: 13 weeks ]
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
Intervention Model: Parallel Assignment
Masking: No masking
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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01359735
802-247-09-022
No
Not Provided
Not Provided
Healthpoint
Healthpoint
Not Provided
Study Chair: Herbert B Slade, MD Healthpoint
Healthpoint
May 2017

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