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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-05-31

Brief Summary

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

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Detailed Description

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Conditions

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Non-melanoma Skin Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

HP802-247

Intervention Type BIOLOGICAL

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

Bacitracin Ointment

bacitracin antibiotic ointment

Group Type ACTIVE_COMPARATOR

Bacitracin Ointment

Intervention Type BIOLOGICAL

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

Interventions

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HP802-247

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

Intervention Type 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).

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No