Abdominal, Incision, Scar, Wound (Morphologic Abnormality)
Conditions
Keywords
wound healing, Scar, abdominoplasty
Brief summary
To evaluate the safety, efficacy and pharmacokinetic profile of ascending concentrations of the study medication compared with vehicle in subjects with incisional wounds
Detailed description
This is primarily a safety study to evaluate the safety of AIV001 when administered near incisional wounds. A unique model was used to assess incisional scarring, safety and biomarker assessments. Women electing to have the abdominoplasty procedure were enrolled in the study and abdominal incisions were generated on the abdominal skin. Up to 10 incisions were made on abdominal skn and treated as assigned. And data collection was conducted up to day 49 when the subjects were exited from the study and the abdominoplasty procedure performed. Exploratory efficacy measures were collected and pharmacokinetic profiles determined.
Interventions
DRUGAIV001
Intradermal injection
Sponsors
AiViva BioPharma, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Treating investigator will administer the study medication. Evaluating Investigator will perform the safety and efficacy evaluations.
Intervention model description
Randomized, double-blind, vehicle-controlled, dose-escalation
Eligibility
Sex/Gender
ALL
Age
21 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Eligible for an abdominoplasty * Nonsmoker * Fitzpatrick I-IV * Weight \>45Kg * BMI \<= 35
Exclusion criteria
* Existing scars in study area, active infection * Any medical history or present conditions that may increase the risk associated with study participation or investigational product administration and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | Day 1 through Day 49 | Local and systemic adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy using Patient and Observer Scar Assessment Scale (6 parameters, 1 normal to 10 worst imaginable) | Day 7 through 49 | Evaluation of the healing of the wounds |
| Modified Vancouver Scar Scale (4 parameters, 0 = normal to 3 or 4 = severe) | Day 7 through 49 | Evaluation of the healing wounds |
| 100 mm Visual Analogue Scale (0 = normal to 10 = poor scar) | Day 7 through 49 | Evaluation of healing wounds |
Countries
United States
Outcome results
None listed