Clinical trial NCT01346969: 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 VARIOUS DOSES AND REGIMENS OF EXC 001 FOR THE AMELIORATION OF SCARRING FOLLOWING REVISION OF SCARS FROM PRIOR BREAST SURGERY IN ADULT SUBJECTS (LEGACY EXCALIARD PROTOCOL # EXC 001-204)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Reduction in Hypertrophic Skin Scarring
Keywords: Skin scarring
cicatrix
breast scar
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-05-04
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Physician Observer Scar Assessment Score at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: Physician Observer Scar Assessment Score
timeFrame: Week 11, 18
measure: Expert Panel Scar Assessment Score
timeFrame: Week 11, 18, 24
measure: Subject Observer Scar Assessment Score
timeFrame: Week 24
measure: Number of Participants With Physician Photonumeric Guide Scar Assessment Score
timeFrame: Week 24
measure: Number of Participants With Participant Photonumeric Guide Scar Assessment Score
timeFrame: Week 24
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: Skin Deep Laser Medical Spa
state: California
city: Whittier
country: United States
facility: Bright Health Physicans Plastic Surgery and Aesthetic Medicine
state: California
city: Lake Worth
country: United States
facility: Altus Research
state: Florida
city: Miami
country: United States
facility: Bayside Ambulatory Center
state: Florida
city: Miami
country: United States
facility: Aesthetic Plastic Surgery Miami
state: Florida
city: Saint Louis
country: United States
facility: Body Aesthetic Plastic Surgery
state: Missouri
city: Montclair
country: United States
facility: New Jersey Plastic Surgery
state: New Jersey
city: Eugene
country: United States
facility: Mark L. Jewell,MD Surgery Center
state: Oregon
city: Tualatin
country: United States
facility: Connall Consmetic Surgery
state: Oregon
city: San Antonio
country: United States
facility: Endeavor Clinical Trials,P.A.
state: Texas
city: San Antonio
country: United States
facility: Texas Plastic Surgery
state: Texas
city: Mountlake Terrace
country: United States
facility: BAXTER Plastic Surgery
state: Washington
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: