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A Phase II Randomized, Open-label Study Investigating the Healing Effects of HP802-247 Versus Antibiotic Ointment in Mohs Micrographic Surgery Patients


Phase 2
18 Years
N/A
Not Enrolling
Both
Non-melanoma Skin Cancer

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Trial Information

A Phase II Randomized, Open-label Study Investigating the Healing Effects of HP802-247 Versus Antibiotic Ointment in Mohs Micrographic Surgery Patients


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Investigator Global Assessment of Healing

Outcome Time Frame:

13 weeks

Safety Issue:

No

Principal Investigator

Herbert B Slade, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Healthpoint

Authority:

United States: Food and Drug Administration

Study ID:

802-247-09-022

NCT ID:

NCT01359735

Start Date:

May 2011

Completion Date:

May 2012

Related Keywords:

  • Non-melanoma Skin Cancer
  • Wound
  • non-melanoma skin cancer
  • Mohs micrographic surgery
  • Head or neck
  • Skin Neoplasms
  • Carcinoma, Basal Cell
  • Carcinoma, Basosquamous
  • Carcinoma, Squamous Cell

Name

Location

Derm Research PLCLouisville, Kentucky  40217