NCT00892723 - A Study to Evaluate the Safety and Efficacy of Additional Doses of AZX100 Drug Product Following Excision of Keloid Scars | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

May 31, 2009

Primary Completion Date

September 30, 2010

Study Completion Date

September 30, 2010

Conditions

Scar PreventionScar Reduction

Interventions

DRUG

AZX100 Drug Product

Subjects were administered AZX100 0.3 mg per linear centimeter (low dose) intradermally at the site of the keloid scar removal. The first dose was given 19-23 days following surgery, and the second dose was given 40-44 days following surgery.

DRUG

Placebo

Subjects were administered placebo (0.9% saline) per linear centimeter intradermally at the site of the keloid scar removal. The first dose was given 19-23 days following surgery, and the second dose was given 40-44 days following surgery.

DRUG

AZX100 Drug Product

Subjects were administered AZX100 10 mg per linear centimeter (high dose) intradermally at the site of the keloid scar removal. The first dose was given 19-23 days following surgery, and the second dose was given 40-44 days following surgery.

Trial Locations (3)

19103

Paddington Testing Company, Inc., Philadelphia

78759

DermResearch, Inc., Austin

91105

Lotus Clinical Research, Inc., Pasadena