Safety and Efficacy of EXC 001 in Subjects Who Have Participated in Prior Studies of EXC 001

A PHASE 2, OPEN-LABEL STUDY TO PROVIDE REVISION OF SCARS RESULTING FROM SURGERY IN PRIOR STUDIES OF EXC 001

The purpose of this study is to provide subjects who participated in prior studies of EXC 001 the opportunity to have their hypertrophic scars surgically revised and treated with EXC 001.

Study Overview

• Status: Completed
• Conditions: Reduction in Severity of Skin Scarring
• Intervention / Treatment: Drug: EXC 001 (currently called PF-06473871)

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Lake Worth, Florida, United States, 33461
      • Altus Research
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University,Division of 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 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy adults who have participated in previous studies of EXC 001.
• Healthy adults who have chosen to have their scars revised.

Exclusion Criteria:

• Currently pregnant or pregnant during the 6 months prior to inclusion in the study, or breast feeding.
• Participation in another clinical trial within 30 days prior to the start of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Open Label	Drug: EXC 001 (currently called PF-06473871); Single dose administered by injection at four different times

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 2 to Week 24
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 appeared to be a rash at the injection sites. Erythematous, raised (indurated) and edematous reactions were considered as positive skin sensitivity reactions. In this outcome measure number of participants with any positive skin sensitivity reaction were reported.	Day 1 up to Week 24
Number of Participants With Clinically Significant Findings in Laboratory Examinations	Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); Hepatobiliary biochemistry: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Albumin, Alkaline Phosphatase, Total Bilirubin ; Renal Function Tests: Blood Urea Nitrogen (BUN), Creatinine, Creatinine Kinase, Uric Acid ; Electrolytes: Sodium, Potassium; Glucose; Urine analysis: (decimal logarithm of reciprocal of hydrogen ion activity )[pH], Specific gravity. Clinically significant laboratory abnormality findings were based on investigator discretion.	Day 1 up to Week 24
Number of Participants With Clinically Significant Change in Vital Signs	Following vital sign parameters were assessed: diastolic blood pressure, systolic blood pressure, respiration rate, pulse rate, temperature and body weight. Number of participants with clinically significant change in any vital sign parameter compared to baseline were reported. Clinically significant change in vital signs criteria were based on investigator's discretion.	Day 1 up to Week 24
Number of Participants With Clinically Significant Findings in Electrocardiogram (ECG) Abnormalities	Following parameters were analyzed: heart rate, PR interval, QT interval, QRS interval and QT interval corrected using Fridericia's formula (QTcF). Clinically significant findings in ECG were based on investigator's discretion.	Day 1 up to Week 24
Number of Participants With Abnormalities in Physical Examinations	Physical examination included the assessment of skin, head, ears, eyes, nose, throat, respiratory system, cardiovascular system, abdomen (including liver and kidneys), musculoskeletal system, neurological system, gastrointestinal system, genitourinary system, endocrine system and lymph nodes. Abnormality in physical examination were based on investigator's discretion.	Day 1 up to Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physician Observer Scar Assessment Score: Individual Sub Scores and Composite Score	Physician assessment of scar was done using a valid published 10-point rating scale. Assessment included following sub scores: vascularity, pigmentation, thickness, relief, pliability, surface area and overall opinion for scar, on a score of 1 = normal skin to 10 = worst scar imaginable. Composite score was the sum of all the sub scores except the overall opinion score and range from 6 (best score) to 60 (worst score).	Week 24
Participant Observer Scar Assessment Score: Individual Sub Scores, Composite Score, Scar Appearance Composite 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 is the sum of all sub scores except overall opinion, range 6 (best) to 60 (worst). Scar appearance composite score is the sum of all sub scores except overall opinion, pain and itching, range 4 (best) to 40 (worst).	Week 24
Number of Scars Classified According to Physician Photonumeric Guide Score Severity Category	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 scars with different ratings of scar severity were reported. Participants may have received treatment for multiple scars (up to 5 scars), results are reported for all scars (individual scar) and most severe scar for all the participants.	Week 24
Number of Scars Classified According to Subject Participant Photonumeric Guide Score Severity Category	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 scars with different ratings of scar severity were reported. Participants may have received treatment for multiple scars (up to 5 scars), results are reported for all scars (individual scar) and most severe scar for all the participants.	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 8, 2011
• Primary Completion (ACTUAL): September 10, 2013
• Study Completion (ACTUAL): September 10, 2013

Study Registration Dates

• First Submitted: December 15, 2011
• First Submitted That Met QC Criteria: December 16, 2011
• First Posted (ESTIMATE): December 19, 2011

Study Record Updates

• Last Update Posted (ACTUAL): August 13, 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; hypertrophic scar; hypertrophic scar prevention
• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix
• Other Study ID Numbers: EXC 001-206; B5301003 (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.