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Safety and Efficacy Study of EXC 001 to Improve the Appearance of Scars From Prior Breast Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01346969
Recruitment Status : Completed
First Posted : May 4, 2011
Results First Posted : September 9, 2021
Last Update Posted : September 9, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE May 1, 2011
First Posted Date  ICMJE May 4, 2011
Results First Submitted Date  ICMJE June 14, 2021
Results First Posted Date  ICMJE September 9, 2021
Last Update Posted Date September 9, 2021
Actual Study Start Date  ICMJE June 1, 2011
Actual Primary Completion Date April 16, 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 12, 2021)
Physician Observer Scar Assessment Score at Week 24 [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 3, 2011)
Assess the efficacy of various doses and regimens of EXC 001 in reducing skin scarring in subjects undergoing elective revision of scars from prior surgery [ Time Frame: 6 months ]
Efficacy will be assessed by:
  • Physician Scar Assessment at 6 months
  • Expert Panel Visual Analog Scale score at 6 months
  • Subject Scar Assessment at 6 months
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 12, 2021)
  • Physician Observer Scar Assessment Score [ Time Frame: Week 11, 18 ]
    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 [ Time Frame: Week 11, 18, 24 ]
    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 [ Time Frame: Week 24 ]
    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 [ Time Frame: Week 24 ]
    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 [ Time Frame: Week 24 ]
    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).
Original Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2011)
Assess the safety of EXC 001 in subjects undergoing elective revision of scars from prior surgery [ Time Frame: 6 months ]
Safety will be assessed by number of participants with adverse events
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of EXC 001 to Improve the Appearance of Scars From Prior Breast Surgery
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Reduction in Hypertrophic Skin Scarring
Intervention  ICMJE
  • Drug: EXC 001
    Single-dose administered by injection four different times
  • Drug: EXC 001
    Single reduced dose compared to Group 1 administered by injection at the same four time periods as Group 1
  • Drug: EXC 001
    Single reduced dose compared to Groups 1 and 2 administered by injection at the same four time periods as Groups 1 and 2
  • Drug: EXC 001
    Same sinlge dose as Group 1 administered by injection at the same four time periods as Groups 1, 2, and 3
Study Arms  ICMJE
  • Active Comparator: Group 1
    Intervention: Drug: EXC 001
  • Placebo Comparator: Group 2
    Intervention: Drug: EXC 001
  • Placebo Comparator: Group 3
    Intervention: Drug: EXC 001
  • Placebo Comparator: Group 4
    Intervention: Drug: EXC 001
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 8, 2011)
68
Original Estimated Enrollment  ICMJE
 (submitted: May 3, 2011)
56
Actual Study Completion Date  ICMJE April 16, 2012
Actual Primary Completion Date April 16, 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01346969
Other Study ID Numbers  ICMJE EXC 001-204
B5301004 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP