A Study to Evaluate the Safety and Efficacy of Additional Doses of AZX100 Drug Product Following Excision of Keloid Scars

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was to determine the safety of AZX100 Drug Product and to determine whether it was effective in preventing or reducing re-growth of surgically removed keloid scars.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Capstone Therapeutics
• Treatments: Polystyrene sulfonic acid

Criteria

Inclusion Criteria:

• Keloid scar located below the neck between 1 and 3 cm long and less than 1 cm at its widest point

• Willing to undergo keloid scar excision surgery

• Healthy adult male or non-pregnant female

• Non-diabetic

• Body Mass Index in the range of 18-35

• No clinically significant abnormal values on a full blood safety screen

• Non-smoker and non-nicotine user for the previous six months

Exclusion Criteria:

• History or clinical evidence of acute or chronic disease

• History of cancer within the last 5 years, except for surgically removed cancers of the skin that are not near the keloid area

• History of anaphylactic shock or anaphylactoid (hypersensitivity) reaction

• Allergy to local anesthesia, including lidocaine and epinephrine

• Dermatologic disorders, except for folliculitis and acne

• On therapy with steroids

• On therapy with a drug that would affect collagen synthesis

• Positive urine test for nicotine or drugs of abuse

• Positive blood test for HIV 1 or 2, hepatitis B or hepatitis C

• Positive blood test for anti-AZX100 antibodies

• Participation in another study within 60 days prior to enrollment

• Blood donation within 7 days before dosing with study drug

• Plasma donation within 3 days before dosing with study drug

• Tattoo within approximately 3 cm of the keloid scar that will be removed

• Apply any lotion or cream on or near the keloid scar that will be removed within 14 days before dosing with study drug

• Use of a tanning bed or tanning light within the 3 months before enrollment

• Intend to use any scar improving product during of the study (1 year)

• History of drug addiction or excessive use of alcohol

• Previous drug treatment of the keloid scar within the last 3 years, or have had any laser, irradiation, or surgical treatment of the keloid scar that will be removed