Trial Outcomes & Findings for Study of GBT009 for Treatment of Incisional Wounds Following Breast Reconstruction Surgery (NCT NCT01053897)

NCT ID: NCT01053897

Last Updated: 2013-10-24

Results Overview

An independent panel was planned to review scar photography to determine more preferable outcomes. Panel was not performed.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 5 participants
• Primary outcome timeframe: 0.5, 1, 2, 3, 6, 9 and 12 Months
• Results posted on: 2013-10-24

Participant Flow

Subjects were screened and enrolled at two US centers (surgical practices) beginning in February 2010. The last subject completed participation in October 2011

Participant milestones

Measure	GBT009/Placebo All subjects acted as their own control receiving both GBT009 and Placebo
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	GBT009/Placebo n=5 Participants All subjects acted as their own control receiving both GBT009 and Placebo
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	48 years STANDARD_DEVIATION 9.43 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants

PRIMARY outcome

Timeframe: 0.5, 1, 2, 3, 6, 9 and 12 Months

Population: All subjects had scar photography completed at study visits. However, due to the early termination of this trial, the independent panel review was not completed.

An independent panel was planned to review scar photography to determine more preferable outcomes. Panel was not performed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 Month (End of Study)

Population: All Subjects included.

Overall preference of the healing/appearance of each scar segment as completed by investigator and subject.

Outcome measures

Measure	GBT009 n=5 Participants All subjects acted as their own control receiving both GBT009 and Placebo	Placebo n=5 Participants All subjects acted as their own control receiving both GBT009 and Placebo	No Difference n=5 Participants No scar segment was preferred to the other
Overall Scar Preference Investigator Evaluation	4 participants	0 participants	1 participants
Overall Scar Preference Subject Evaluation	2 participants	2 participants	1 participants

SECONDARY outcome

Timeframe: 12 Month (End of Study)

Population: All subjects were included

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)

Outcome measures

Measure	GBT009 n=5 Participants All subjects acted as their own control receiving both GBT009 and Placebo	Placebo n=5 Participants All subjects acted as their own control receiving both GBT009 and Placebo	No Difference No scar segment was preferred to the other
Patient Observer Scar Assessment Scale (POSAS) Vascularization (Observer)	4.8 units on a scale Standard Deviation 1.79	4.6 units on a scale Standard Deviation 1.82	—
Patient Observer Scar Assessment Scale (POSAS) Pigmentation (Observer)	4.4 units on a scale Standard Deviation 1.14	4.4 units on a scale Standard Deviation 1.52	—
Patient Observer Scar Assessment Scale (POSAS) Thickness (Observer)	3.4 units on a scale Standard Deviation 2.07	2.6 units on a scale Standard Deviation 1.52	—
Patient Observer Scar Assessment Scale (POSAS) Relief (Observer)	3.6 units on a scale Standard Deviation 1.82	3.4 units on a scale Standard Deviation 1.52	—
Patient Observer Scar Assessment Scale (POSAS) Pliability (Observer)	3 units on a scale Standard Deviation 1.41	2.4 units on a scale Standard Deviation 1.52	—
Patient Observer Scar Assessment Scale (POSAS) Pain (Subject)	1 units on a scale Standard Deviation 0	1 units on a scale Standard Deviation 0	—
Patient Observer Scar Assessment Scale (POSAS) Itching (Subject)	1 units on a scale Standard Deviation 0	1 units on a scale Standard Deviation 0	—
Patient Observer Scar Assessment Scale (POSAS) Color (Subject)	5.4 units on a scale Standard Deviation 2.88	4.6 units on a scale Standard Deviation 3.20	—
Patient Observer Scar Assessment Scale (POSAS) Stiffness (Subject)	3.4 units on a scale Standard Deviation 3.78	3 units on a scale Standard Deviation 3.94	—
Patient Observer Scar Assessment Scale (POSAS) Thickness (Subject)	3.8 units on a scale Standard Deviation 3.56	3.8 units on a scale Standard Deviation 3.70	—
Patient Observer Scar Assessment Scale (POSAS) Irregularity (Subject)	4 units on a scale Standard Deviation 2.74	4 units on a scale Standard Deviation 2.65	—

SECONDARY outcome

Timeframe: 12 Month (End of Study)

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)

Outcome measures

Measure	GBT009 n=5 Participants All subjects acted as their own control receiving both GBT009 and Placebo	Placebo n=5 Participants All subjects acted as their own control receiving both GBT009 and Placebo	No Difference No scar segment was preferred to the other
Manchester Scar Scale (MSS) Visual Analog Scale (0-10)	4.26 units on a scale Standard Deviation 2.62	4.26 units on a scale Standard Deviation 2.32	—
Manchester Scar Scale (MSS) Color (1-4)	2.6 units on a scale Standard Deviation 0.55	2.4 units on a scale Standard Deviation 0.55	—
Manchester Scar Scale (MSS) Contour (1-4)	1.6 units on a scale Standard Deviation 0.55	1.4 units on a scale Standard Deviation 0.55	—
Manchester Scar Scale (MSS) Distortion (1-4)	1.8 units on a scale Standard Deviation 0.45	1.8 units on a scale Standard Deviation 0.45	—
Manchester Scar Scale (MSS) Texture (1-4)	4.8 units on a scale Standard Deviation 1.79	4.6 units on a scale Standard Deviation 1.82	—

Adverse Events

GBT009/Placebo

Serious events: 3 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	GBT009/Placebo n=5 participants at risk All subjects acted as their own control receiving both GBT009 and Placebo
Infections and infestations Toxic shock syndrome streptococcal	20.0% 1/5 • Number of events 1 • 1 year
Infections and infestations Streptococcal infection	20.0% 1/5 • Number of events 1 • 1 year
Cardiac disorders Cardiac failure congestive	20.0% 1/5 • Number of events 1 • 1 year
Respiratory, thoracic and mediastinal disorders Dyspnoea	20.0% 1/5 • Number of events 1 • 1 year
Surgical and medical procedures Implantable defibrillator insertion	20.0% 1/5 • Number of events 1 • 1 year
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer metastatic	20.0% 1/5 • Number of events 1 • 1 year

Other adverse events

Measure	GBT009/Placebo n=5 participants at risk All subjects acted as their own control receiving both GBT009 and Placebo
Blood and lymphatic system disorders Ecchymosis	20.0% 1/5 • Number of events 1 • 1 year
Gastrointestinal disorders Oropharyngeal pain	20.0% 1/5 • Number of events 2 • 1 year
Gastrointestinal disorders Diarrhoea	20.0% 1/5 • Number of events 1 • 1 year
General disorders Fatigue	20.0% 1/5 • Number of events 1 • 1 year
General disorders Flank pain	20.0% 1/5 • Number of events 1 • 1 year
General disorders Oedema peripheral	20.0% 1/5 • Number of events 1 • 1 year
General disorders Pyrexia	20.0% 1/5 • Number of events 1 • 1 year
Infections and infestations Subcutaneous abscess	20.0% 1/5 • Number of events 1 • 1 year
Infections and infestations Upper respiratory tract infection	20.0% 1/5 • Number of events 1 • 1 year
Infections and infestations Urinary Tract Infection	40.0% 2/5 • Number of events 2 • 1 year
Injury, poisoning and procedural complications Seroma	20.0% 1/5 • Number of events 1 • 1 year
Musculoskeletal and connective tissue disorders Back Pain	40.0% 2/5 • Number of events 2 • 1 year
Musculoskeletal and connective tissue disorders Arthralgia	20.0% 1/5 • Number of events 1 • 1 year
Reproductive system and breast disorders Vaginitis bacterial	20.0% 1/5 • Number of events 1 • 1 year
Respiratory, thoracic and mediastinal disorders Nasopharyngitis	20.0% 1/5 • Number of events 1 • 1 year
Skin and subcutaneous tissue disorders Erythema	20.0% 1/5 • Number of events 1 • 1 year
Surgical and medical procedures Incisional drainage	20.0% 1/5 • Number of events 1 • 1 year

Additional Information

Gerri Henwood, CEO

Garnet BioTherapeutics, Inc.

Phone: 484-395-2440

Email: ghenwood@garnetbio.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place