Study of GBT009 for Treatment of Incisional Wounds Following Breast Reconstruction Surgery

A Phase 2, Multicenter, Double-Blind, Placebo-Controlled Study of GBT009 for Treatment of Incisional Wounds Following Breast Reconstruction Surgery

NCT01053897•Garnet BioTherapeutics, Inc.

View on ClinicalTrials.gov

Summary

The primary objective of this study is to assess whether intradermal injections of GBT009 along full thickness incisions following surgery results in an improvement in scar appearance.

Eligibility

Age

18 - 70 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•be a female between 18 and 70 years of age, inclusive
•have a body mass index ≤ 32 kg/m2 and a body weight between 50 and 95 kg, inclusive
•be scheduled for a mastectomy with breast reconstruction surgery using an abdominal flap technique
•for women diagnosed with breast cancer, has standard of care treatment for breast cancer prior to surgery and will have standard of care treatment for breast cancer after surgery
•for subjects of childbearing potential, be surgically sterile or using an insertable, injectable, transdermal, or combination oral contraceptive approved by the FDA through completion of the study and have negative results on a serum pregnancy test done before administration of study medication (women who are postmenopausal \[no menses for at least 2 years\] are also eligible to participate)
•be able to understand the study procedures, agree to participate in the study program, and voluntarily provide written informed consent

Exclusion Criteria

•have clinically significant laboratory abnormalities at screening
•have, as determined by the investigator or the sponsor's medical monitor, a history or clinical manifestations of significant renal, hepatic, cardiovascular, metabolic, neurologic, psychiatric, coagulopathic disorder or other condition that would preclude participation in the study
•have received treatment for a severe, uncontrolled inflammatory disease or allergic condition within three months of screening
•have a life expectancy ≤ 2 years
•have a history of alcoholism or drug addiction or abuse within 5 years
•have evidence of a clinically significant abnormality upon evaluation of 12 lead ECG
•have evidence of any past or present clinically significant medical condition, including skin disease, that would impair wound healing
•have a history of keloid scar formation
•have existing scarring in the abdominal area of study that would interfere with the efficacy assessments
•have a history of (within the past 5 years) or an active malignancy, other than breast cancer
+5 more criteria

Locations (2)

Garnet BioTherapeutics Investigational Site

Chicago, Illinois, United States

Garnet BioTherapeutics Investigational Site

Rochester, New York, United States

Key Dates

Start Date

January 1, 2010

Primary Completion Date

October 1, 2011

Completion Date

October 1, 2011

Last Updated

October 24, 2013

Enrollment

ACTUAL participants

Conditions

Scar Formation

Interventions

GBT009

BIOLOGICAL

Placebo

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 24, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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