Safety and Efficacy Study of Different Dose Levels of EXC 001 to Improve the Appearance of Scars in Subjects Undergoing Elective Abdominoplasty

A PHASE 2, RANDOMIZED, DOUBLE-BLIND, WITHIN-SUBJECT CONTROLLED, DOSE-RANGING STUDY TO EVALUATE EFFICACY AND SAFETY OF EXC 001 FOR THE TREATMENT OF INCISION SCARS IN THE PANNUS OF SUBJECTS UNDERGOING AN ELECTIVE ABDOMINOPLASTY

This study will compare how well EXC 001 works versus placebo in reducing the appearance of scars in subjects undergoing elective abdominoplasty. 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): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University,Division of Plastic Surgery
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • Body Aesthetic Plastic Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Subjects must have sufficient excess abdominal tissue to qualify for a standard elective abdominoplasty
• Subject has chosen to have an elective abdominoplasty
• Medically healthy with normal screening results
• Subjects must not be pregnant or lactating

Exclusion Criteria:

• Subjects with existing scars or significant striae on the abdominal pannus
• Females who are currently pregnant or pregnant during the 12 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
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Intradermal injections of EXC 001 and placebo given on various schedules.
Experimental: EXC 001	Drug: EXC 001; Intradermal injections of EXC 001 and placebo given on various schedules.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part B: 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 mm = best possible scar and a score of 100 mm = worst possible scar, where higher scores indicate worse condition. The difference was calculated for scars at Week 13 as EXC 001 score minus placebo score, thus a negative difference would indicate that the EXC 001-treated scars had lower scar severity. The score was defined as the within participant average difference between EXC 001- and Placebo-treated scars at Week 13.	Week 13 of Part B

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part B: Physician Observer Global Assessment Scar Score	Physician observer global assessment of scar score was done using a valid published 10-point rating scale. Physicians rated severity of each scar on a scale of 1 = normal skin to 10 = worst scar imaginable. Each scar was given a single score and the differences in scores between the matched pairs of scars were calculated. There were 4 differences within each dose level that were averaged to create a single score for each participant at each dose level. The score was defined as the within participant average difference between EXC 001 and Placebo.	Week 13 of Part B
Part B: Number of Participants With Clinically Significant Change From Baseline in Vital Signs	Following vital sign parameters were assessed: diastolic blood pressure, systolic blood pressure, respiration rate, pulse rate, temperature and weight. Number of participants with clinically significant change in any vital sign parameter compared to Baseline were reported. Criteria for clinically significant change in any vital sign parameter compared to baseline was based on investigator's discretion.	Part B: Day 1 up to Week 14
Part B: Number of Participants With Clinically Significant Changes in 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. Criteria for clinically significant findings in physical examination was based on investigator's discretion.	Part B: Day 1 up to Week 14
Part B: Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Findings	Following parameters were analyzed for ECG abnormality: PR interval, QRS interval, QT interval, QT interval corrected using the Fridericia's correction (QTc), heart rate (HR). A standard, single 12-lead ECG was taken and results was classified as normal, having a clinically insignificant abnormality, or having a clinically significant abnormality. Number of participants with clinically significant abnormality in ECG compared to baseline were reported. Criteria for clinically significant abnormality in ECG compared to baseline was based on investigator's discretion.	Week 13 of Part B
Part B: Number of Participants With Clinically Significant Abnormal Laboratory Findings	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 abnormal change in any laboratory parameter compared to baseline were reported.	Part B: Day 1 up to Week 13
Part A and B: Number of Participants With Positive Skin Sensitivity Reaction	The skin sensitivity reaction was assessed only at the skin sensitivity reaction testing sites. Erythematous, raised (indurated) and edematous reactions were considered as positive skin sensitivity reactions. The number of participants that experienced any positive skin sensitivity reactions were reported.	From Day 21 of Part A up to Week 2 of Part B

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 1, 2009
• Primary Completion (Actual): July 7, 2010
• Study Completion (Actual): July 7, 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): September 20, 2021
• Last Update Submitted That Met QC Criteria: August 24, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Scarring
• Other Study ID Numbers: EXC 001-201; B5301009 (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