Clinical trial NCT01037413: Safety and Efficacy Study of EXC 001 to Improve the Appearance of Scars From Prior Breast Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Scar Prevention
Keywords: Scarring
Cicatrix
Fibrosis
Pathologic Process
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-12-23
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Expert Panel Scar Assessment Score at Week 12
timeFrame: Part B: Week 12
Secondary outcomes:
measure: Expert Panel Scar Assessment Score at Week 8 and 24
timeFrame: Part B: Week 8 and 24
measure: Physician Observer Scar Assessment Score at Week 12 and 24
timeFrame: Part B: Week 12 and 24
measure: Participant Observer Scar Assessment Score at Week 12 and 24
timeFrame: Part B: Week 12 and 24
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: 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)
measure: Number of Participants With Abnormal Physical Examination Findings
timeFrame: Screening (up to Day 21 prior to Day 1 of Part A), Part B: Day 1, Week 12
measure: Number of Participants With Clinically Significant Findings in Electrocardiogram (ECG)
timeFrame: Screening (up to Day 21 prior to Day 1 of Part A), Part B: Week 12
measure: Number of Participants With Clinically Significant Findings in Laboratory Examinations
timeFrame: Screening (up to Day 21 prior to Day 1 of Part A), Part B: Day 1 up to Week 12
measure: Number of Participants With Clinically Significant Findings in Vital Signs
timeFrame: Screening (up to Day 21 prior to Day 1 of Part A), Part B: Day 1 up to Week 12
measure: Number of Participants With Positive Skin Sensitivity Reaction
timeFrame: Part A: Day 1, Part B: Week 2 up to Week 24
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps medical
state: California
city: Chicago
country: United States
facility: Northwestern University,Division of Plastic Surgery
state: Illinois
city: Saint Louis
country: United States
facility: Body Aesthetic Plastic Surgery
state: Missouri
city: Eugene
country: United States
facility: Jewell Plastic Surgery Center
state: Oregon
city: Tualatin
country: United States
facility: Connall Consmetic Surgery
state: Oregon
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: