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

NCT01346969 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: EXC 001-204B5301004
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 12

Brief Summary

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.

Conditions

Reduction in Hypertrophic Skin Scarring

Keywords

Skin scarring; cicatrix; breast scar

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Physician Observer Scar Assessment Score

  Week 11, 18

• Expert Panel Scar Assessment Score

  Week 11, 18, 24

• Subject Observer Scar Assessment Score

  Week 24

• Number of Participants With Physician Photonumeric Guide Scar Assessment Score

  Week 24

• Number of Participants With Participant Photonumeric Guide Scar Assessment Score

  Week 24

Study Arms (4)

Group 1

ACTIVE COMPARATOR

Drug: EXC 001

Group 2

PLACEBO COMPARATOR

Drug: EXC 001

Group 3

PLACEBO COMPARATOR

Drug: EXC 001

Group 4

PLACEBO COMPARATOR

Drug: EXC 001

Interventions

EXC 001 DRUG

Single-dose administered by injection four different times

Group 1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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 the study.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (12)

Skin Deep Laser Medical Spa

Pasadena, California, 91105, United States

Location

Bright Health Physicans Plastic Surgery and Aesthetic Medicine

Whittier, California, 90602, United States

Location

Altus Research

Lake Worth, Florida, 33461, United States

Location

Bayside Ambulatory Center

Miami, Florida, 33133, United States

Location

Aesthetic Plastic Surgery Miami

Miami, Florida, 33146, United States

Location

Body Aesthetic Plastic Surgery

St Louis, Missouri, 63141, United States

Location

New Jersey Plastic Surgery

Montclair, New Jersey, 07042, United States

Location

Mark L. Jewell,MD Surgery Center

Eugene, Oregon, 97401, United States

Location

Connall Consmetic Surgery

Tualatin, Oregon, 97062, United States

Location

Endeavor Clinical Trials,P.A.

San Antonio, Texas, 78229, United States

Location

Texas Plastic Surgery

San Antonio, Texas, 78240-1670, United States

Location

BAXTER Plastic Surgery

Mountlake Terrace, Washington, 98043, United States

Location

Related Links

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

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; 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: May 1, 2011
• First Posted: May 4, 2011
• Study Start: June 1, 2011
• Primary Completion: April 16, 2012
• Study Completion: April 16, 2012
• Last Updated: September 9, 2021
• Results First Posted: September 9, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share

Locations

US (12)