NCT01037413CompletedPhase 2
A PHASE 2, RANDOMIZED, DOUBLE-BLIND, WITHIN-SUBJECT CONTROLLED STUDY TO EVALUATE EFFICACY AND SAFETY OF EXC 001 FOR THE AMELIORATION OF SCARRING FOLLOWING REVISION OF SCARS RESULTING FROM PRIOR BREAST SURGERY IN ADULT FEMALE SUBJECTS
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 25
- Locations
- 5
- Primary Endpoint
- Expert Panel Scar Assessment Score at Week 12
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
EXC 001
Experimental
Intervention: EXC 001 (Drug)
Placebo
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Expert Panel Scar Assessment Score at Week 12
Time Frame: Part B: Week 12
Scar assessment by an expert panel was done on blinded photographs using 100 millimeter (mm) visual analog scale (VAS) where a score of 0 mm = best possible scar and a score of 100 mm = worst possible scar, where higher scores indicate worse condition.
Secondary Outcomes
- Expert Panel Scar Assessment Score at Week 8 and 24(Part B: Week 8 and 24)
- Physician Observer Scar Assessment Score at Week 12 and 24(Part B: Week 12 and 24)
- Participant Observer Scar Assessment Score at Week 12 and 24(Part B: Week 12 and 24)
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(Part A: Day 1; Part B, Active Dosing: Week 2 up to Week 13; Part B, Post Dosing: Week 13 to end of the study (Week 24))
- Number of Participants With Abnormal Physical Examination Findings(Screening (up to Day 21 prior to Day 1 of Part A), Part B: Day 1, Week 12)
- Number of Participants With Clinically Significant Findings in Laboratory Examinations(Screening (up to Day 21 prior to Day 1 of Part A), Part B: Day 1 up to Week 12)
- Number of Participants With Clinically Significant Findings in Vital Signs(Screening (up to Day 21 prior to Day 1 of Part A), Part B: Day 1 up to Week 12)
- Number of Participants With Clinically Significant Findings in Electrocardiogram (ECG)(Screening (up to Day 21 prior to Day 1 of Part A), Part B: Week 12)
- Number of Participants With Positive Skin Sensitivity Reaction(Part A: Day 1, Part B: Week 2 up to Week 24)
Investigators
Study Sites (5)
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