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Completed

NCT Number: NCT01359735

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.

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Key information

Conditions

Non-Melanoma Skin Cancer Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Derm Research PLC

Louisville, Kentucky, 40217, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HP802-247

Biological

High dose HP 802-247, applied at each visit (Week 1-13) or until healed

Bacitracin Ointment

Biological

One dose of Bacitracin ointment consists of 50 units/1 gram. This will be applied daily for 12 weeks (or until healed).

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Healthpoint

Industry

Registry information

Official study title

A Phase II Randomized, Open-label Study Investigating the Healing Effects of HP802-247 Versus Antibiotic Ointment in Mohs Micrographic Surgery Patients

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
May 25, 2011
Registry last updated
Jun 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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