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

NCT01359735 | Completed Phase 2 Results

• 1 other identifier: 802-247-09-022
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Non-melanoma Skin Cancer

Keywords

Wound; non-melanoma skin cancer; Mohs micrographic surgery; Head or neck

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• The Number of Subjects With Complete Wound Closure 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

  Over the 12 week treatment period

• Investigator Reported Signs and Symptoms

  At each evaluation visit: Weeks 3 and 12 post-surgery.

• Subject Reported Signs and Symptoms

  At each evaluation visit: Weeks 3, and 12 post-surgery.

Study Arms (2)

HP802-247

ACTIVE COMPARATOR

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

Bacitracin Ointment

ACTIVE COMPARATOR

bacitracin antibiotic ointment

Biological: Bacitracin Ointment

Interventions

HP802-247 BIOLOGICAL

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

HP802-247

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).

Bacitracin Ointment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Healthpoint: lead

Study Sites (1)

Derm Research PLC

Louisville, Kentucky, 40217, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Results Point of Contact

• Title: Jaime E Dickerson, PhD
• Organization: Smith & Nephew

Jaime.Dickerson@smith-nephew.com

1-817-302-3914

Study Officials

• Herbert B Slade, MD

  Healthpoint

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2011
• First Posted: May 25, 2011
• Study Start: May 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: May 1, 2012
• Last Updated: June 29, 2017
• Results First Posted: June 29, 2017

Record last verified: 2017-05

Locations

US (1)