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

• Status: Completed
• Trial end date: 2010-07-01
• 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 between 1 and 3 cm long, less than 1 cm at its widest point

• willing to undergo keloid scar removal 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 malignant neoplasm within the last 5 years, except for surgically removed cancers of the skin that are not on the keloid area

• history of anaphylactic shock or anaphylactoid (hypersensitivity) reaction

• allergy to local anesthesia, including lidocaine and epinephrine

• ongoing 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

• donate blood within 7 days before dosing with study drug

• donate plasma within 3 days before dosing with study drug

• have a tattoo within 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 a tanning bed or tanning light within 3 months before enrollment

• intend to use any scar improving product during the study (one year)

• history of drug addiction or excessive use of alcohol

• previous drug treatment of the keloid scar that will be removed within the last 3 years; any laser, irradiation, or surgery of the keloid scar that will be removed