Phase 2
N=30
Safety and Efficacy Study of Different Dose Levels of EXC 001 to Improve the Appearance of Scars in Subjects Undergoing Elective Abdominoplasty
Scar Prevention
Bottom Line
View on ClinicalTrials.gov: NCT01038297 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcome: Primary: Part B: Expert Panel Scar Assessment Score — -3.16; 0.18; 1.45; 2.91 millimeters
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- EXC 001 (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Pfizer
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part B: Expert Panel Scar Assessment Score |
-3.16; 0.18; 1.45; 2.91; -4.78; -4.05 | — |
| SECONDARY Part B: Physician Observer Global Assessment Scar Score |
-0.84; -0.44; -0.68; -0.05; -0.75; -0.70 | — |
| SECONDARY Part B: Number of Participants With Clinically Significant Change From Baseline in Vital Signs |
0; 0; 0 | — |
| SECONDARY Part B: Number of Participants With Clinically Significant Changes in Physical Examination Findings |
1; 0; 1 | — |
| SECONDARY Part B: Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Findings |
0; 0; 0 | — |
| SECONDARY Part B: Number of Participants With Clinically Significant Abnormal Laboratory Findings |
0; 0; 0 | — |
| SECONDARY Part A and B: Number of Participants With Positive Skin Sensitivity Reaction |
0; 0; 0 | — |
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
- Subjects with existing scars or significant striae on the abdominal pannus
- 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 (NCT01038297). 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.