Phase 2
N=68
Safety and Efficacy Study of EXC 001 to Improve the Appearance of Scars From Prior Breast Surgery
Reduction in Hypertrophic Skin Scarring
Bottom Line
View on ClinicalTrials.gov: NCT01346969 ↗Enrolled (actual)
68
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcome: Primary: Physician Observer Scar Assessment Score at Week 24 — 0.0; -0.5; 0.8; -0.3 units on a scale — p=1.000
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- EXC 001 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Apr 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Physician Observer Scar Assessment Score at Week 24 |
0.0; -0.5; 0.8; -0.3; 0.0; -0.6 | 1.000 |
| SECONDARY Physician Observer Scar Assessment Score |
-0.3; -0.6; 0.2; 0.3; 0.0; -0.2 | — |
| SECONDARY Expert Panel Scar Assessment Score |
2.0; 0.4; 3.7; -4.1; 2.2; -2.7 | — |
| SECONDARY Subject Observer Scar Assessment Score |
-0.1; 0.0; 1.2; -0.2; -0.2; 0.2 | — |
| SECONDARY Number of Participants With Physician Photonumeric Guide Scar Assessment Score |
10; 4; 1; 0; 6; 3 | — |
| SECONDARY Number of Participants With Participant Photonumeric Guide Scar Assessment Score |
8; 1; 1; 1; 8; 1 | — |
Summary
The study will investigate the efficacy of various doses and regimens of EXC 001 in reducing skin scarring in subjects undergoing revision of scars from prior surgery. The study will also evaluate the safety and tolerability of EXC 001 and placebo.
Eligibility Criteria
Inclusion Criteria
- Subjects must have previous had breast surgery resulting in unacceptable scars.
- Subject has chosen to have breast scars revised.
- Subject 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 the study.
Data sourced from ClinicalTrials.gov (NCT01346969). 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.