Phase 2
N=25
Safety and Efficacy Study of EXC 001 to Improve the Appearance of Scars From Prior Breast Surgery
Scar Prevention
Bottom Line
View on ClinicalTrials.gov: NCT01037413 ↗Enrolled (actual)
25
Serious AEs
1.5%
Results posted
Aug 2021
Primary outcome: Primary: Expert Panel Scar Assessment Score at Week 12 — 36.6; 51.4 millimeter — p=<0.001
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
- Apr 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Expert Panel Scar Assessment Score at Week 12 |
36.6; 51.4 | <0.001 sig |
| SECONDARY Expert Panel Scar Assessment Score at Week 8 and 24 |
34.7; 49.4; 30.7; 56.7 | <0.001 sig |
| SECONDARY Physician Observer Scar Assessment Score at Week 12 and 24 |
4.0; 5.2; 3.4; 4.6; 3.8; 5.4 | 0.033 sig |
| SECONDARY Participant Observer Scar Assessment Score at Week 12 and 24 |
2.0; 2.7; 2.6; 3.0; 6.3; 6.8 | 0.067 |
| SECONDARY Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
9; 16; 3; 0; 1; 0 | — |
| SECONDARY Number of Participants With Abnormal Physical Examination Findings |
14; 3; 1 | — |
| SECONDARY Number of Participants With Clinically Significant Findings in Electrocardiogram (ECG) |
0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Findings in Laboratory Examinations |
0; 2 | — |
| SECONDARY Number of Participants With Clinically Significant Findings in Vital Signs |
0; 1 | — |
| SECONDARY Number of Participants With Positive Skin Sensitivity Reaction |
0; 0 | — |
Summary
This study will compare how well EXC 001 works to improve the appearance of scars in subjects undergoing breast scar revision surgery. The study will also evaluate the safety of EXC 001 in healthy adult subjects.
Eligibility Criteria
Inclusion Criteria
- Subjects must have previously had breast surgery resulting in unacceptable scars
- Subject has chosen to have the breast scars revised
- Subjects must not be pregnant or lactating
Exclusion Criteria
- Currently pregnant or pregnant during the 6 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 (NCT01037413). 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.