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

Non-melanoma Skin Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01359735
• Other study ID #: 802-247-09-022
• Status: Completed
• Phase: Phase 2
• First received: May 23, 2011
• Last updated: September 19, 2013
• Start date: May 2011
• Est. completion date: May 2012

Study information

• Verified date: September 2013
• Source: Healthpoint
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: May 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Non-melanoma Skin Cancer
• Skin Neoplasms

Intervention

Biological:
• HP802-247
High dose HP 802-247, applied at each visit (Week 1-13) or until healed
• Bacitracin Ointment
One dose of Bacitracin ointment consists of 50 units/1 gram. This will be applied daily for 12 weeks (or until healed).

Locations

Country	Name	City	State
United States	Derm Research PLC	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Healthpoint

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigator Global Assessment of Healing		13 weeks	No
Secondary	Adverse events		13 weeks	Yes