Clinical trial NCT01037985: Safety and Efficacy Study of EXC 001 to Improve the Appearance of Scars in Subjects Undergoing Elective Abdominoplasty
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 OF THE SURGICAL INCISION IN SUBJECTS UNDERGOING AN ELECTIVE ABDOMINOPLASTY
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: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: This study will compare how well EXC 001 works versus placebo in reducing the appearance of scars in subjects undergoing elective abdominoplasty. The study will also evaluate the safety of EXC 001 in healthy adult subjects.


Eligibility criteria: Inclusion Criteria:

* Subjects must have sufficient excess abdominal tissue to qualify for a standard elective abdominoplasty
* Subject has chosen to have an elective abdominoplasty
* Medically healthy with normal screening results
* Subjects must not be pregnant or lactating

Exclusion Criteria:

* Females who are currently pregnant or pregnant during the 12 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: Part B
timeFrame: Week 12
Secondary outcomes:
measure: Expert Panel Scar Assessment Score at Week 24: Part B
timeFrame: Week 24
measure: Physician Observer Scar Assessment Score at Week 12 and 24: Part B
timeFrame: Week 12 and 24
measure: Participants Observer Scar Assessment Score at Week 12 and 24: Part B
timeFrame: Week 12 and 24
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Day 1 of Part A up to Week 24 of Part B
measure: Number of Participants With Abnormal Physical Examinations Findings: Part A and Part B
timeFrame: Day 1 of Part A up to Week 12 of Part B
measure: Number of Participants With Clinically Significant Findings in Electrocardiogram (ECG): Part A and Part B
timeFrame: Day 1 of Part A up to Week 12 of Part B
measure: Number of Participants With Clinically Significant Findings in Laboratory Examinations: Part A and Part B
timeFrame: Day 1 of Part A up to Week 12 of Part B
measure: Number of Participants With Clinically Significant Findings in Vital Signs and Weight: Part A and Part B
timeFrame: Day 1 of Part A up to Week 12 of Part B
measure: Number of Participants With Positive Skin Sensitivity Reaction: Part A and Part B
timeFrame: Day 21 of Part A up to Day 14 of Part B
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: Barnes Jewish West County Hospital
state: Missouri
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: