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.

Study Overview

• Status: Completed
• Conditions: Non-melanoma Skin Cancer
• Intervention / Treatment: Biological: HP802-247; Biological: Bacitracin Ointment

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40217
      • Derm Research PLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Primary Efficacy Measure Was the Investigator's Global Assessment of Healing (IGAH).	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.	13 weeks- The IGAH was measured at study Weeks 4 and 13

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Number of Subjects With Complete Wound Closure at Each Evaluation Visit.	Complete wound closure was assessed at each evaluation visit.	Over 12 weeks or until wound closure, which ever occurred first. Following completion of treatment subjects were followed for a further 4 weeks
Time in Days to Wound Closure	The Kaplan-Meier survival analysis was used to calculate the mean time in days to complete wound closure.	Over the 12 week treatment period
Investigator Reported Signs and Symptoms	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.	At each evaluation visit: Weeks 3 and 12 post-surgery.
Subject Reported Signs and Symptoms	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.	At each evaluation visit: Weeks 3, and 12 post-surgery.

Collaborators and Investigators

• Sponsor: Healthpoint

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: May 23, 2011
• First Submitted That Met QC Criteria: May 24, 2011
• First Posted (Estimate): May 25, 2011

Study Record Updates

• Last Update Posted (Actual): June 29, 2017
• Last Update Submitted That Met QC Criteria: May 31, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Wound; Mohs micrographic surgery; non-melanoma skin cancer; Head or neck
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Skin Neoplasms; Anti-Infective Agents, Local; Anti-Infective Agents; Anti-Bacterial Agents; Bacitracin
• Other Study ID Numbers: 802-247-09-022