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

Phase 2CompletedNCT01359735

Healthpoint8 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non-melanoma Skin Cancer

Interventions

HP802-247BIOLOGICAL

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

Bacitracin OintmentBIOLOGICAL

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Derm Research PLC

Louisville, Kentucky, United States

Outcomes

Primary Outcomes

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.

Time frame: 13 weeks- The IGAH was measured at study Weeks 4 and 13

Secondary Outcomes

The Number of Subjects With Complete Wound Closure at Each Evaluation Visit.

Complete wound closure was assessed 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

Time in Days to Wound Closure

The Kaplan-Meier survival analysis was used to calculate the mean time in days to complete wound closure.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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