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

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)

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.

Study Overview

• Status: Completed
• Conditions: Reduction in Hypertrophic Skin Scarring
• Intervention / Treatment: Drug: EXC 001; Drug: EXC 001; Drug: EXC 001; Drug: EXC 001

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Pasadena, California, United States, 91105
      • Skin Deep Laser Medical Spa
    • Whittier, California, United States, 90602
      • Bright Health Physicans Plastic Surgery and Aesthetic Medicine
  • Florida
    • Lake Worth, Florida, United States, 33461
      • Altus Research
    • Miami, Florida, United States, 33133
      • Bayside Ambulatory Center
    • Miami, Florida, United States, 33146
      • Aesthetic Plastic Surgery Miami
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • Body Aesthetic Plastic Surgery
  • New Jersey
    • Montclair, New Jersey, United States, 07042
      • New Jersey Plastic Surgery
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Mark L. Jewell,MD Surgery Center
    • Tualatin, Oregon, United States, 97062
      • Connall Consmetic Surgery
  • Texas
    • San Antonio, Texas, United States, 78229
      • Endeavor Clinical Trials,P.A.
    • San Antonio, Texas, United States, 78240-1670
      • Texas Plastic Surgery
  • Washington
    • Mountlake Terrace, Washington, United States, 98043
      • BAXTER Plastic Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Group 1	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
PLACEBO_COMPARATOR: Group 2	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
PLACEBO_COMPARATOR: Group 3	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
PLACEBO_COMPARATOR: Group 4	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 11, 18
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.	Week 11, 18, 24
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.	Week 24
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).	Week 24
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).	Week 24

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2011
• Primary Completion (ACTUAL): April 16, 2012
• Study Completion (ACTUAL): April 16, 2012

Study Registration Dates

• First Submitted: May 1, 2011
• First Submitted That Met QC Criteria: May 3, 2011
• First Posted (ESTIMATE): May 4, 2011

Study Record Updates

• Last Update Posted (ACTUAL): September 9, 2021
• Last Update Submitted That Met QC Criteria: August 12, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Skin scarring; cicatrix; breast scar
• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix
• Other Study ID Numbers: EXC 001-204; B5301004 (OTHER: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No