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

Healthpoint

Status and phase: Completed; Phase 2

Conditions: Non-melanoma Skin Cancer

Treatments: Biological: Bacitracin Ointment; Biological: HP802-247

Study type: Interventional

Funder types: Industry

Identifiers

NCT01359735

802-247-09-022

Details and patient eligibility

About

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

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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8 participants in 2 patient groups

HP802-247

Active Comparator group

Description:

allogeneic, growth arrested keratinocytes and fibroblasts: final concentration of 5.0 M cells/mL with a ratio of 1:9 keratinocytes:fibroblasts, applied weekly

Treatment:

Biological: HP802-247

Bacitracin Ointment

Active Comparator group

Description:

bacitracin antibiotic ointment

Treatment:

Biological: Bacitracin Ointment