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Safety and Efficacy Study of EXC 001 to Improve the Appearance of Scars From Prior Breast Surgery | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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 VARIOUS DOSES AND REGIMENS OF EXC 001 FOR THE AMELIORATION OF SCARRING FOLLOWING REVISION OF SCARS FROM PRIOR BREAST SURGERY IN ADULT SUBJECTS (LEGACY EXCALIARD PROTOCOL # EXC 001-204)

NCT01346969•Pfizer

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.

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 the study.

Locations (12)

Skin Deep Laser Medical Spa

Pasadena, California, United States

Bright Health Physicans Plastic Surgery and Aesthetic Medicine

Whittier, California, United States

Altus Research

Lake Worth, Florida, United States

Bayside Ambulatory Center

Miami, Florida, United States

Aesthetic Plastic Surgery Miami

Miami, Florida, United States

Body Aesthetic Plastic Surgery

St Louis, Missouri, United States

New Jersey Plastic Surgery

Montclair, New Jersey, United States

Mark L. Jewell,MD Surgery Center

Eugene, Oregon, United States

Connall Consmetic Surgery

Tualatin, Oregon, United States

Endeavor Clinical Trials,P.A.

San Antonio, Texas, United States

Key Dates

Start Date

June 1, 2011

Primary Completion Date

April 16, 2012

Completion Date

April 16, 2012

Last Updated

September 9, 2021

Enrollment

ACTUAL participants

Conditions

Reduction in Hypertrophic Skin Scarring

Interventions

EXC 001

DRUG

EXC 001

DRUG

EXC 001

DRUG

EXC 001

DRUG