Safety and Efficacy Study of EXC 001 to Improve the Appearance of Scars From Prior Breast Surgery
Primary Purpose
Reduction in Hypertrophic Skin Scarring
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
EXC 001
EXC 001
EXC 001
EXC 001
Sponsored by
About this trial
This is an interventional treatment trial for Reduction in Hypertrophic Skin Scarring focused on measuring Skin scarring, cicatrix, breast scar
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.
Sites / Locations
- Skin Deep Laser Medical Spa
- Bright Health Physicans Plastic Surgery and Aesthetic Medicine
- Altus Research
- Bayside Ambulatory Center
- Aesthetic Plastic Surgery Miami
- Body Aesthetic Plastic Surgery
- New Jersey Plastic Surgery
- Mark L. Jewell,MD Surgery Center
- Connall Consmetic Surgery
- Endeavor Clinical Trials,P.A.
- Texas Plastic Surgery
- BAXTER Plastic Surgery
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Placebo Comparator
Placebo Comparator
Placebo Comparator
Arm Label
Group 1
Group 2
Group 3
Group 4
Arm Description
Outcomes
Primary Outcome Measures
Physician Observer Scar Assessment Score at Week 24
Physician assessment of scar was done using a valid published 10-point rating scale. Physician rated vascularity, pigmentation, thickness, relief, pliability, surface area and overall opinion for scar on a score of 1 = normal skin to 10 = worst scar imaginable, where lower scores indicated better outcome. Composite score was the sum of all the scores, except the overall opinion score, and range from 6 (best score) to 60 (worst score), where lower scores indicated better outcome. Within participant treatment difference was assessed between the treatment regimens each participant received.
Secondary Outcome Measures
Physician Observer Scar Assessment Score
Physician observer scar assessment score was done using a valid published 10-point rating scale. Physician rated vascularity, pigmentation, thickness, relief, pliability, surface area and overall opinion for a scar on a score of 1 = normal skin to 10 = worst scar imaginable, where lower scores indicated better outcome. Composite score was the sum of all the scores except the overall opinion score and range from 6 (best score) to 60 (worst score), where lower scores indicated better outcome. Within participant treatment difference was assessed between the treatment regimens each participant received.
Expert Panel Scar Assessment Score
Scar assessment by an expert panel was done on blinded photographs using 100 millimeter (mm) visual analog scale (VAS) where a score of 0 = best possible scar and a score of 100 = worst possible scar, where lower scores indicated better outcome. The rater first marked a rating for the "worse" scar and then rated the other scar. The difference between these two ratings was the "improvement of scar severity." If there was no difference, the expert could check a box to indicate that determination. This method provided information on the absolute severity of the scars as well as the differences between the two scars in the pair.
Subject Observer Scar Assessment Score
Participants rated pain, itching, color, stiffness, thickness, irregularity, and overall opinion of scar on 10-point scale. For pain and itching associated with scar: range = 1 (no, not at all) to 10 (yes, worst imaginable) and for other parameters associated with scar compared to normal skin: range = 1 (no, same as normal skin) to 10 (yes, very different). Composite score = sum of all scores except overall opinion and range 6 (best) to 60 (worst). Scar appearance composite score = sum of all scores except overall opinion, pain and itching, range 4 (best) to 40 (worst). Within participant treatment difference was assessed between the treatment regimens each participant received. A lower score indicated a better outcome.
Number of Participants With Physician Photonumeric Guide Scar Assessment Score
Physician rated severity of each scar using a photonumeric guide on a scale range from 1 to 5 (where 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe). Number of participants with different ratings of scar severity were reported. Same participant was reported twice, once for each breast's scar (dosing for 1 breast = 4 times EXC 001 and for other breast = 3 times).
Number of Participants With Participant Photonumeric Guide Scar Assessment Score
Participants rated severity of each scar using a photonumeric guide on a scale range from 1 to 5 (where 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe). Number of participants with different ratings of scar severity were reported. Same participant was reported twice, once for each breast's scar (dosing for 1 breast = 4 times EXC 001 and for other breast = 3 times).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01346969
Brief Title
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
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2011 (Actual)
Primary Completion Date
April 16, 2012 (Actual)
Study Completion Date
April 16, 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Reduction in Hypertrophic Skin Scarring
Keywords
Skin scarring, cicatrix, breast scar
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Active Comparator
Arm Title
Group 2
Arm Type
Placebo Comparator
Arm Title
Group 3
Arm Type
Placebo Comparator
Arm Title
Group 4
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
EXC 001
Intervention Description
Single-dose administered by injection four different times
Intervention Type
Drug
Intervention Name(s)
EXC 001
Intervention Description
Single reduced dose compared to Group 1 administered by injection at the same four time periods as Group 1
Intervention Type
Drug
Intervention Name(s)
EXC 001
Intervention Description
Single reduced dose compared to Groups 1 and 2 administered by injection at the same four time periods as Groups 1 and 2
Intervention Type
Drug
Intervention Name(s)
EXC 001
Intervention Description
Same sinlge dose as Group 1 administered by injection at the same four time periods as Groups 1, 2, and 3
Primary Outcome Measure Information:
Title
Physician Observer Scar Assessment Score at Week 24
Description
Physician assessment of scar was done using a valid published 10-point rating scale. Physician rated vascularity, pigmentation, thickness, relief, pliability, surface area and overall opinion for scar on a score of 1 = normal skin to 10 = worst scar imaginable, where lower scores indicated better outcome. Composite score was the sum of all the scores, except the overall opinion score, and range from 6 (best score) to 60 (worst score), where lower scores indicated better outcome. Within participant treatment difference was assessed between the treatment regimens each participant received.
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Physician Observer Scar Assessment Score
Description
Physician observer scar assessment score was done using a valid published 10-point rating scale. Physician rated vascularity, pigmentation, thickness, relief, pliability, surface area and overall opinion for a scar on a score of 1 = normal skin to 10 = worst scar imaginable, where lower scores indicated better outcome. Composite score was the sum of all the scores except the overall opinion score and range from 6 (best score) to 60 (worst score), where lower scores indicated better outcome. Within participant treatment difference was assessed between the treatment regimens each participant received.
Time Frame
Week 11, 18
Title
Expert Panel Scar Assessment Score
Description
Scar assessment by an expert panel was done on blinded photographs using 100 millimeter (mm) visual analog scale (VAS) where a score of 0 = best possible scar and a score of 100 = worst possible scar, where lower scores indicated better outcome. The rater first marked a rating for the "worse" scar and then rated the other scar. The difference between these two ratings was the "improvement of scar severity." If there was no difference, the expert could check a box to indicate that determination. This method provided information on the absolute severity of the scars as well as the differences between the two scars in the pair.
Time Frame
Week 11, 18, 24
Title
Subject Observer Scar Assessment Score
Description
Participants rated pain, itching, color, stiffness, thickness, irregularity, and overall opinion of scar on 10-point scale. For pain and itching associated with scar: range = 1 (no, not at all) to 10 (yes, worst imaginable) and for other parameters associated with scar compared to normal skin: range = 1 (no, same as normal skin) to 10 (yes, very different). Composite score = sum of all scores except overall opinion and range 6 (best) to 60 (worst). Scar appearance composite score = sum of all scores except overall opinion, pain and itching, range 4 (best) to 40 (worst). Within participant treatment difference was assessed between the treatment regimens each participant received. A lower score indicated a better outcome.
Time Frame
Week 24
Title
Number of Participants With Physician Photonumeric Guide Scar Assessment Score
Description
Physician rated severity of each scar using a photonumeric guide on a scale range from 1 to 5 (where 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe). Number of participants with different ratings of scar severity were reported. Same participant was reported twice, once for each breast's scar (dosing for 1 breast = 4 times EXC 001 and for other breast = 3 times).
Time Frame
Week 24
Title
Number of Participants With Participant Photonumeric Guide Scar Assessment Score
Description
Participants rated severity of each scar using a photonumeric guide on a scale range from 1 to 5 (where 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe). Number of participants with different ratings of scar severity were reported. Same participant was reported twice, once for each breast's scar (dosing for 1 breast = 4 times EXC 001 and for other breast = 3 times).
Time Frame
Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Skin Deep Laser Medical Spa
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Bright Health Physicans Plastic Surgery and Aesthetic Medicine
City
Whittier
State/Province
California
ZIP/Postal Code
90602
Country
United States
Facility Name
Altus Research
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33461
Country
United States
Facility Name
Bayside Ambulatory Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
Facility Name
Aesthetic Plastic Surgery Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
Facility Name
Body Aesthetic Plastic Surgery
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
New Jersey Plastic Surgery
City
Montclair
State/Province
New Jersey
ZIP/Postal Code
07042
Country
United States
Facility Name
Mark L. Jewell,MD Surgery Center
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Connall Consmetic Surgery
City
Tualatin
State/Province
Oregon
ZIP/Postal Code
97062
Country
United States
Facility Name
Endeavor Clinical Trials,P.A.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Texas Plastic Surgery
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240-1670
Country
United States
Facility Name
BAXTER Plastic Surgery
City
Mountlake Terrace
State/Province
Washington
ZIP/Postal Code
98043
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=EXC001-204&StudyName=Safety%20and%20Efficacy%20Study%20of%20EXC%20001%20to%20Improve%20the%20Appearance%20of%20Scars%20From%20Prior%20Breast%20Surgery
Description
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Safety and Efficacy Study of EXC 001 to Improve the Appearance of Scars From Prior Breast Surgery
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