Phase 2
N=59
A Study to Evaluate the Safety and Efficacy of Additional Doses of AZX100 Drug Product Following Excision of Keloid Scars
Scar Prevention · Scar Reduction
Bottom Line
View on ClinicalTrials.gov: NCT00892723 ↗Enrolled (actual)
59
Serious AEs
0.0%
Results posted
Oct 2012
Primary outcome: Primary: Differences Among the 3 Dosage Groups in the Patient (PSAS) and Observer (OSAS) Scar Assessment Scale (POSAS) Scores — 23.29; 24.11; 21.33; 18.53 Units on a scale — p=0.87
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AZX100 Drug Product (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Capstone Therapeutics
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Differences Among the 3 Dosage Groups in the Patient (PSAS) and Observer (OSAS) Scar Assessment Scale (POSAS) Scores |
23.29; 24.11; 21.33; 18.53; 23.47; 18.33 | 0.87 |
| SECONDARY Between-group Mean Differences in Visual Analog Scale (VAS) Scores by Independent Blinded Raters |
71.9; 77.0; 68.1; 56.1; 62.2; 54.3 | 0.23 |
| SECONDARY Between-group Mean Differences in Objective Measures Obtained Via 3D Photography (Elevation, Length, Width) |
27.71; 27.90; 27.51; 13.48; 15.67; 12.52 | 0.73 |
| SECONDARY Between-group Mean Differences in Objective Measures Obtained Via 3D Photography (Volume) |
0.42; 0.65; 0.37; -0.04; -0.06; -0.06 | 0.16 |
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
Data sourced from ClinicalTrials.gov (NCT00892723). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.