Phase 2
N=14
Safety and Efficacy of EXC 001 in Subjects Who Have Participated in Prior Studies of EXC 001
Reduction in Severity of Skin Scarring
Bottom Line
View on ClinicalTrials.gov: NCT01494922 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcome: Primary: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) — 8; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- EXC 001 (currently called PF-06473871) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
8; 0 | — |
| PRIMARY Number of Participants With Positive Skin Sensitivity Reaction |
2 | — |
| PRIMARY Number of Participants With Clinically Significant Findings in Laboratory Examinations |
— | — |
| PRIMARY Number of Participants With Clinically Significant Change in Vital Signs |
— | — |
| PRIMARY Number of Participants With Clinically Significant Findings in Electrocardiogram (ECG) Abnormalities |
— | — |
| PRIMARY Number of Participants With Abnormalities in Physical Examinations |
3 | — |
| SECONDARY Physician Observer Scar Assessment Score: Individual Sub Scores and Composite Score |
4.63; 4.02; 3.83; 4.55; 4.06; 3.97 | — |
| SECONDARY Participant Observer Scar Assessment Score: Individual Sub Scores, Composite Score, Scar Appearance Composite Score |
6.21; 2.46; 2.03; 6.72; 5.76; 5.56 | — |
| SECONDARY Number of Scars Classified According to Physician Photonumeric Guide Score Severity Category |
5; 12; 4; 1; 6; 2 | — |
| SECONDARY Number of Scars Classified According to Subject Participant Photonumeric Guide Score Severity Category |
6; 7; 6; 3; 6; 2 | — |
Summary
The purpose of this study is to provide subjects who participated in prior studies of EXC 001 the opportunity to have their hypertrophic scars surgically revised and treated with EXC 001.
Eligibility Criteria
Inclusion Criteria
- Healthy adults who have participated in previous studies of EXC 001.
- Healthy adults who have chosen to have their scars revised.
Exclusion Criteria
- Currently pregnant or pregnant during the 6 months prior to inclusion in the study, or breast feeding.
- Participation in another clinical trial within 30 days prior to the start of the study.
Data sourced from ClinicalTrials.gov (NCT01494922). 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.