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 EXC 001 FOR THE AMELIORATION OF SCARRING FOLLOWING REVISION OF SCARS RESULTING FROM PRIOR BREAST SURGERY IN ADULT FEMALE SUBJECTS

This study will compare how well EXC 001 works to improve the appearance of scars in subjects undergoing breast scar revision surgery. The study will also evaluate the safety of EXC 001 in healthy adult subjects.

Study Overview

• Status: Completed
• Conditions: Scar Prevention
• Intervention / Treatment: Drug: EXC 001; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • Scripps medical
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University,Division of Plastic Surgery
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • Body Aesthetic Plastic Surgery
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Jewell Plastic Surgery Center
    • Tualatin, Oregon, United States, 97062
      • Connall Consmetic Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Subjects must have previously had breast surgery resulting in unacceptable scars
• Subject has chosen to have the breast scars revised
• Subjects 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 this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Multiple intradermal injections of EXC 001 and placebo
Experimental: EXC 001	Drug: EXC 001; Multiple intradermal injections of EXC 001 and placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Expert Panel Scar Assessment Score at Week 12	Scar assessment by an expert panel was done on blinded photographs using 100 millimeter (mm) visual analog scale (VAS) where a score of 0 mm = best possible scar and a score of 100 mm = worst possible scar, where higher scores indicate worse condition.	Part B: Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Expert Panel Scar Assessment Score at Week 8 and 24	Scar assessment by an expert panel was done on blinded photographs using 100 mm VAS where a score of 0 mm = best possible scar and a score of 100 mm = worst possible scar, where higher scores indicate worse condition.	Part B: Week 8 and 24
Physician Observer Scar Assessment Score at Week 12 and 24	Physician observer 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 a scar on a score of 1= normal skin to 10= worst scar imaginable, where higher scores indicate worse condition. 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 higher scores indicate worse condition.	Part B: Week 12 and 24
Participant Observer Scar Assessment Score at Week 12 and 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), where higher scores indicate worse condition. Composite score = sum of all scores except overall opinion, range 6 (best) to 60 (worst), where higher scores indicate worse condition. Scar appearance composite score = sum of all scores except overall opinion, pain and itching, range 4 (best) to 40 (worst), where higher scores indicate worse condition.	Part B: Week 12 and 24
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included SAEs and all non-SAEs that occurred during the study.	Part A: Day 1; Part B, Active Dosing: Week 2 up to Week 13; Part B, Post Dosing: Week 13 to end of the study (Week 24)
Number of Participants With Abnormal Physical Examination Findings	Physical examination included the assessment of skin; head, ears, eyes, nose, and throat; respiratory; cardiovascular; abdomen; musculoskeletal; neurological; gastrointestinal; genitourinary; endocrine and lymph nodes. Abnormal physical examination findings was based on investigator's discretion.	Screening (up to Day 21 prior to Day 1 of Part A), Part B: Day 1, Week 12
Number of Participants With Clinically Significant Findings in Electrocardiogram (ECG)	Number of participants with clinically significant abnormality in ECG were reported. Clinical significance was based on investigator's discretion.	Screening (up to Day 21 prior to Day 1 of Part A), Part B: Week 12
Number of Participants With Clinically Significant Findings in Laboratory Examinations	Laboratory analysis included hematology, biochemistry and urinalysis. Hematology range: basophils (bas) 0-0.2, eosinophils (eos) 0-0.4, leukocytes (leu) 4-10.5, lymphocytes (lym) 0.7-4.5, neutrophils (neu) 1.8-7.8, platelet 140-415, monocytes (mon) 0.1-1 in 10^9 per liter; bas/leu 0-3, eos/leu 0-7, lym/leu 14-46, mon/leu 4-13, neu/leu and neu/leu 40-74 in percentage, erythrocytes 3.8-5.1 10^12/L, hematocrit 0.34-0.44 L/L, hemoglobin 115-150 gram per liter (g/L). Biochemistry range: creatine kinase 24-173, alkaline phosphatase 25-150, alanine aminotransferase (AT) and aspartate AT 0-40 in International units per liter; creatinine 50-88, urate 89-399, bilirubin 2-21 in micromole per liter, glucose 3.6-5.5, potassium 3.5-5.5, sodium 135-148, blood urea nitrogen 1.8-9.3 in millimole/L, albumin 35-55 g/L. Urinalysis parameters: pH (5-7.5), specific gravity (1.005-1.03). Participants with clinically significant findings were reported.	Screening (up to Day 21 prior to Day 1 of Part A), Part B: Day 1 up to Week 12
Number of Participants With Clinically Significant Findings in Vital Signs	Following vital sign parameters were assessed: diastolic blood pressure, systolic blood pressure, respiration rate, pulse rate, and temperature. Clinical significance was based on investigator's discretion.	Screening (up to Day 21 prior to Day 1 of Part A), Part B: Day 1 up to Week 12
Number of Participants With Positive Skin Sensitivity Reaction	Participants were instructed to inform the investigator in case of any itching, redness, pain or any other symptom that appears to be a rash at the injection sites. Erythematous, raised (indurated) and edematous reactions were considered as positive skin sensitivity reactions.	Part A: Day 1, Part B: Week 2 up to 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): December 22, 2009
• Primary Completion (Actual): April 9, 2010
• Study Completion (Actual): April 9, 2010

Study Registration Dates

• First Submitted: December 21, 2009
• First Submitted That Met QC Criteria: December 22, 2009
• First Posted (Estimate): December 23, 2009

Study Record Updates

• Last Update Posted (Actual): August 2, 2021
• Last Update Submitted That Met QC Criteria: July 9, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Fibrosis; Pathologic Process; Scarring; Cicatrix
• Other Study ID Numbers: EXC 001-203; B5301011 (Other Identifier: 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