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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

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.

Condition or disease Intervention/treatment Phase
Reduction in Hypertrophic Skin Scarring Drug: EXC 001 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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)
Actual Study Start Date : June 1, 2011
Actual Primary Completion Date : April 16, 2012
Actual Study Completion Date : April 16, 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

Arm Intervention/treatment
Active Comparator: Group 1 Drug: EXC 001
Single-dose administered by injection four different times

Placebo Comparator: Group 2 Drug: EXC 001
Single reduced dose compared to Group 1 administered by injection at the same four time periods as Group 1

Placebo Comparator: Group 3 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

Placebo Comparator: Group 4 Drug: EXC 001
Same sinlge dose as Group 1 administered by injection at the same four time periods as Groups 1, 2, and 3




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01346969


Locations
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United States, California
Skin Deep Laser Medical Spa
Pasadena, California, United States, 91105
Bright Health Physicans Plastic Surgery and Aesthetic Medicine
Whittier, California, United States, 90602
United States, Florida
Altus Research
Lake Worth, Florida, United States, 33461
Bayside Ambulatory Center
Miami, Florida, United States, 33133
Aesthetic Plastic Surgery Miami
Miami, Florida, United States, 33146
United States, Missouri
Body Aesthetic Plastic Surgery
Saint Louis, Missouri, United States, 63141
United States, New Jersey
New Jersey Plastic Surgery
Montclair, New Jersey, United States, 07042
United States, Oregon
Mark L. Jewell,MD Surgery Center
Eugene, Oregon, United States, 97401
Connall Consmetic Surgery
Tualatin, Oregon, United States, 97062
United States, Texas
Endeavor Clinical Trials,P.A.
San Antonio, Texas, United States, 78229
Texas Plastic Surgery
San Antonio, Texas, United States, 78240-1670
United States, Washington
BAXTER Plastic Surgery
Mountlake Terrace, Washington, United States, 98043
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01346969    
Other Study ID Numbers: EXC 001-204
B5301004 ( Other Identifier: Alias Study Number )
First Posted: May 4, 2011    Key Record Dates
Results First Posted: September 9, 2021
Last Update Posted: September 9, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
Skin scarring
cicatrix
breast scar
Additional relevant MeSH terms:
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Cicatrix
Fibrosis
Pathologic Processes