A Pilot Phase 2a Blinded, Placebo Controlled, Multicenter Parallel Group, Dose Ranging Study to Evaluate the Safety and Preliminary Efficacy of Additional Doses of AZX100 Drug Product Following Excision of Keloids
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Capstone Therapeutics
- Enrollment
- 59
- Locations
- 3
- Primary Endpoint
- Differences Among the 3 Dosage Groups in the Patient (PSAS) and Observer (OSAS) Scar Assessment Scale (POSAS) Scores
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Low Dose
Intervention: AZX100 Drug Product (Drug)
High Dose
Intervention: AZX100 Drug Product (Drug)
Placebo
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Differences Among the 3 Dosage Groups in the Patient (PSAS) and Observer (OSAS) Scar Assessment Scale (POSAS) Scores
Time Frame: 12 Months
Efficacy was based on the difference between mean POSAS scores of placebo, 0.3 mg AZX100, and 1 mg AZX100 12 months after surgery. This gave four comparisons to placebo: patient or observer and 0.3 mg and 1 mg AZX100. PSAS included patients' ratings on a scale of 1-10 (1 was normal skin or no complaints and 10 was the worst imaginable scar or the worst difference) for the following: Is the scar painful? Is the scar itching? Is the color of the scar different? Is the scar more stiff? Is the thickness of the scar different? Is the scar irregular? The possible minimum score was 6 and the maximum (worst) score was 60. OSAS included observers' ratings on a scale of 1-10 (1 was normal skin and 10 was the worst scar imaginable) for vascularization, pigmentation, thickness, relief, and pliability. The possible minimum score was 5 and the possible maximum (worst) score was 50.
Secondary Outcomes
- Between-group Mean Differences in Visual Analog Scale (VAS) Scores by Independent Blinded Raters(12 Months)
- Between-group Mean Differences in Objective Measures Obtained Via 3D Photography (Elevation, Length, Width)(12 Months)
- Between-group Mean Differences in Objective Measures Obtained Via 3D Photography (Volume)(12 months)