Phase 2
N=41
Safety and Efficacy Study of EXC 001 to Improve the Appearance of Scars in Subjects Undergoing Elective Abdominoplasty
Scar Prevention
Bottom Line
View on ClinicalTrials.gov: NCT01037985 ↗Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcome: Primary: Expert Panel Scar Assessment Score at Week 12: Part B — 37.8; 42.1 millimeter — p=0.168
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- EXC 001 (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Expert Panel Scar Assessment Score at Week 12: Part B |
37.8; 42.1 | 0.168 |
| SECONDARY Expert Panel Scar Assessment Score at Week 24: Part B |
37.9; 37.6 | 0.858 |
| SECONDARY Physician Observer Scar Assessment Score at Week 12 and 24: Part B |
3.7; 4.7; 3.2; 3.7; 3.2; 4.6 | 0.003 sig |
| SECONDARY Participants Observer Scar Assessment Score at Week 12 and 24: Part B |
2.0; 1.9; 1.8; 1.8; 5.8; 6.5 | 0.773 |
| SECONDARY Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
7; 21; 0; 0 | — |
| SECONDARY Number of Participants With Abnormal Physical Examinations Findings: Part A and Part B |
3; 3 | — |
| SECONDARY Number of Participants With Clinically Significant Findings in Electrocardiogram (ECG): Part A and Part B |
0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Findings in Laboratory Examinations: Part A and Part B |
0; 2 | — |
| SECONDARY Number of Participants With Clinically Significant Findings in Vital Signs and Weight: Part A and Part B |
0; 0 | — |
| SECONDARY Number of Participants With Positive Skin Sensitivity Reaction: Part A and Part B |
0; 4 | — |
Summary
This study will compare how well EXC 001 works versus placebo in reducing the appearance of scars in subjects undergoing elective abdominoplasty. The study will also evaluate the safety of EXC 001 in healthy adult subjects.
Eligibility Criteria
Inclusion Criteria
- Subjects must have sufficient excess abdominal tissue to qualify for a standard elective abdominoplasty
- Subject has chosen to have an elective abdominoplasty
- Medically healthy with normal screening results
- Subjects must not be pregnant or lactating
Exclusion Criteria
- Females who are currently pregnant or pregnant during the 12 months prior to inclusion in the study, or lactating
- Participation in another clinical trial within 30 days prior to the start of the study
- Any other condition or prior therapy, which, in the opinion of the PI, would make the subject unsuitable for this study
Data sourced from ClinicalTrials.gov (NCT01037985). 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.