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

NCT01037413 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: EXC 001-203B5301011
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Scar Prevention

Keywords

Scarring; Cicatrix; Fibrosis; Pathologic Process

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Expert Panel Scar Assessment Score at Week 8 and 24

  Part B: Week 8 and 24

• Physician Observer Scar Assessment Score at Week 12 and 24

  Part B: Week 12 and 24

• Participant Observer Scar Assessment Score at Week 12 and 24

  Part B: Week 12 and 24

• Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  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

  Screening (up to Day 21 prior to Day 1 of Part A), Part B: Day 1, Week 12

Study Arms (2)

EXC 001

EXPERIMENTAL

Drug: EXC 001

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

EXC 001 DRUG

Multiple intradermal injections of EXC 001 and placebo

EXC 001

Placebo DRUG

Multiple intradermal injections of EXC 001 and placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (5)

Scripps medical

La Jolla, California, 92037, United States

Location

Northwestern University,Division of Plastic Surgery

Chicago, Illinois, 60611, United States

Location

Body Aesthetic Plastic Surgery

St Louis, Missouri, 63141, United States

Location

Jewell Plastic Surgery Center

Eugene, Oregon, 97401, United States

Location

Connall Consmetic Surgery

Tualatin, Oregon, 97062, United States

Location

Related Links

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

MeSH Terms

Conditions

Cicatrix; Fibrosis; Pathologic Processes

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2009
• First Posted: December 23, 2009
• Study Start: December 22, 2009
• Primary Completion: April 9, 2010
• Study Completion: April 9, 2010
• Last Updated: August 2, 2021
• Results First Posted: August 2, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share

Locations

US (5)