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

• ClinicalTrials.gov Identifier: NCT01359735
• Recruitment Status: Completed
• First Posted: May 25, 2011
• Results First Posted: June 29, 2017
• Last Update Posted: June 29, 2017
• Sponsor: Healthpoint
• Information provided by (Responsible Party): Healthpoint

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Non-melanoma Skin Cancer	Biological: HP802-247; Biological: Bacitracin Ointment	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 8 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Randomized, Open-label Study Investigating the Healing Effects of HP802-247 Versus Antibiotic Ointment in Mohs Micrographic Surgery Patients
• Study Start Date: May 2011
• Actual Primary Completion Date: November 2011
• Actual Study Completion Date: May 2012

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, Kentucky

Derm Research PLC

Louisville, Kentucky, United States, 40217

Sponsors and Collaborators

Healthpoint

Investigators

• Study Chair: Herbert B Slade, MD; Healthpoint

More Information

• Responsible Party: Healthpoint
• ClinicalTrials.gov Identifier: NCT01359735
• Other Study ID Numbers: 802-247-09-022
• First Posted: May 25, 2011
• Results First Posted: June 29, 2017
• Last Update Posted: June 29, 2017
• Last Verified: May 2017

Keywords provided by Healthpoint:

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

Additional relevant MeSH terms:

Skin Neoplasms; Neoplasms by Site; Neoplasms; Skin Diseases; Bacitracin; Anti-Infective Agents, Local; Anti-Infective Agents; Anti-Bacterial Agents