Clinical trial NCT00825916: A Study to Evaluate the Safety and Efficacy 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 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: 2009-01-21
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 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

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: Philadelphia
country: United States
facility: Paddington Testing Company, Inc.
state: Pennsylvania
city: Austin
country: United States
facility: DermResearch, Inc.
state: Texas
Study officials:
References: