Clinical trial NCT00892723: A Study to Evaluate the Safety and Efficacy of Additional Doses of AZX100 Drug Product Following Excision of Keloid Scars
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Scar Prevention
Scar Reduction
Keywords: AZX100
Patient and Observer Scar Assessment Scale
POSAS
Visual Analog Scale
VAS
Keloid
Scarring
Scar reduction
Scar prevention
Lead sponsor: Capstone Therapeutics
Sponsor class: INDUSTRY
First posted: 2009-05-04
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Differences Among the 3 Dosage Groups in the Patient (PSAS) and Observer (OSAS) Scar Assessment Scale (POSAS) Scores
timeFrame: 12 Months
Secondary outcomes:
measure: Between-group Mean Differences in Visual Analog Scale (VAS) Scores by Independent Blinded Raters
timeFrame: 12 Months
measure: Between-group Mean Differences in Objective Measures Obtained Via 3D Photography (Elevation, Length, Width)
timeFrame: 12 Months
measure: Between-group Mean Differences in Objective Measures Obtained Via 3D Photography (Volume)
timeFrame: 12 months
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: Lotus Clinical Research, Inc.
state: California
city: Philadelphia
country: United States
facility: Paddington Testing Company, Inc.
state: Pennsylvania
city: Austin
country: United States
facility: DermResearch, Inc.
state: Texas
Study officials:
References: