Phase 2
N=59
A Study to Evaluate the Safety and Efficacy of AZX100 Drug Product Following Excision of Keloid Scars
Scar Prevention · Scar Reduction
Bottom Line
View on ClinicalTrials.gov: NCT00825916 ↗Enrolled (actual)
59
Serious AEs
3.4%
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 — 13.3; 17.7; 15.9; 17.1 Units on a scale — p=0.078
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
- Jul 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 |
13.3; 17.7; 15.9; 17.1; 17.3; 15.5 | 0.078 |
| SECONDARY Between-group Mean Differences in Visual Analog Scale (VAS) Scores by Independent Blinded Raters |
62.3; 55.9; 54.9; 60.3; 57.2; 58.1 | 0.74 |
| SECONDARY Between-group Mean Differences in Objective Measures Obtained Via 3D Photography (Elevation, Length, Width) |
26.8; 24.7; 27.2; 10.8; 13.3; 11.3 | 0.34 |
| SECONDARY Between-group Mean Differences in Objective Measures Obtained Via 3D Photography (Volume) |
0.3; 0.3; 0.5; -0.0; -0.0; -0.1 | 0.95 |
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
Data sourced from ClinicalTrials.gov (NCT00825916). 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.