Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Capstone Therapeutics
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | A Study to Evaluate the Safety and Efficacy of Additional Doses of AZX100 Drug Product Following Excision of Keloid Scars
