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

Capstone Therapeutics

Status and phase

Completed

Phase 2

Conditions

Scar Reduction

Scar Prevention

Treatments

Drug: Placebo

Drug: AZX100 Drug Product

Study type

Interventional

Funder types

Industry

Identifiers

NCT00892723

OL-ASCAR-05

Details and patient eligibility

About

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.

Enrollment

59 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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