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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Garnet BioTherapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01053897
First received: January 20, 2010
Last updated: August 19, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Scar Formation
Biological: GBT009
Biological: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Double-Blind, Placebo-Controlled Study of GBT009 for Treatment of Incisional Wounds Following Breast Reconstruction Surgery

Resource links provided by NLM:


Further study details as provided by Garnet BioTherapeutics, Inc.:

Primary Outcome Measures:
  • Photography- Independent Scar Assessment Panel [ Time Frame: 0.5, 1, 2, 3, 6, 9 and 12 Months ] [ Designated as safety issue: No ]
    An independent panel was planned to review scar photography to determine more preferable outcomes. Panel was not performed.


Secondary Outcome Measures:
  • Overall Scar Preference [ Time Frame: 12 Month (End of Study) ] [ Designated as safety issue: No ]
    Overall preference of the healing/appearance of each scar segment as completed by investigator and subject.

  • Patient Observer Scar Assessment Scale (POSAS) [ Time Frame: 12 Month (End of Study) ] [ Designated as safety issue: No ]

    Rating by subject and investigator (observer) to assess various factors of scar segment appearance/characteristics on a numeric scale (0-10). Individual parameters rated by the subject or observer according to a 0-10 scale where 0 equals no symptoms or difference from normal (better) and 10 equals the worst possible symptoms or difference from normal (worse).

    Outcomes measured at 0.5, 1, 2, 3, 6, 9 and 12 Months. Reported Data is end of study (12 months)


  • Manchester Scar Scale (MSS) [ Time Frame: 12 Month (End of Study) ] [ Designated as safety issue: No ]

    Rating by investigator to assess various factors of scar appearance/characteristics on numeric scales.

    MSS includes a visual analog scale (10 cm; 0 excellent appearance, 10 poor appearance) and four descriptive characteristics rated 1 to 4 according to the following descriptions.

    Color: Perfect (1), Slight mismatch (2), Obvious mismatch (3), Gross mismatch (4).

    Contour: Flush with surrounding skin (1), Slightly proud/indented (2), Hypertrophic (3), Keloid (4).

    Distortion: None (1), Mild (2), Moderate (3), Severe (4). Texture: Normal (1), Just palpable (2), Firm (3), Hard (4).

    Outcomes measured at 0.5, 1, 2, 3, 6, 9 and 12 Months. Reported Data is end of study (12 months)



Enrollment: 5
Study Start Date: January 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GBT009 Biological: GBT009
Intradermal Injection following surgery
Placebo Comparator: Placebo Biological: Placebo
Intradermal Injection following surgery

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: Subjects must meet all of the following criteria to be considered eligible to participate in the study:

  • 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: Subjects who meet any of the following criteria will be excluded from participating in the study:

  • 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
  • have a breast cancer that has been staged at Stage IIIB, IIIC or IV
  • have received a cytotoxic agent or have been treated with radiation within 90 days of screening and/or, in the opinion of the investigator, will likely require treatment in the 30 day period following the administration of study medication
  • have received anticoagulation medication within 5 days of dosing with study medication
  • have participated in any study involving an investigational product within 30 days before dosing with study medication
  • have routinely used tobacco products within 6 months preceding the study period
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01053897

Locations
United States, Illinois
Garnet BioTherapeutics Investigational Site
Chicago, Illinois, United States
United States, New York
Garnet BioTherapeutics Investigational Site
Rochester, New York, United States
Sponsors and Collaborators
Garnet BioTherapeutics, Inc.
Investigators
Study Director: Garnet Study Manager Garnet BioTherapeutics, Inc.
  More Information

No publications provided

Responsible Party: Garnet BioTherapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01053897     History of Changes
Other Study ID Numbers: GBT-09-001
Study First Received: January 20, 2010
Results First Received: March 11, 2013
Last Updated: August 19, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Garnet BioTherapeutics, Inc.:
GBT009
incisional scar
breast reconstruction

ClinicalTrials.gov processed this record on October 23, 2014