Trial Outcomes & Findings for Safety Study of Cosmetic Tissue Augmentation in People of Color (NCT NCT01147172)
NCT ID: NCT01147172
Last Updated: 2017-10-17
Results Overview
Percentage of Subjects with keloid formation at the site of injection
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
2 Weeks
Results posted on
2017-10-17
Participant Flow
A total of 122 subjects were screened for the study at 9 centers. Twenty-two screen failed and 100 were were enrolled in this study. No subject who failed screening was treated during the CTA-0701 study. Of the treated subjects 96% completed the follow-up visit 24 weeks after Treatment.
Elevess was injected into the mid to deep dermis of each nasolabial fold. Subjects were telephoned at 72 (±24) hours to assess the subjects for possible AEs and injection site reactions. All subjects returned 14 ± 3 days after initial treatment for evaluation of AEs and to assess whether a Touch-up was needed.
Participant milestones
| Measure |
Elevess
Gel implant (dermal filler) composed of hyaluronan produced by Streptococcus equi (bacterial fermentation) that is cross-linked and suspended in phosphate buffered saline with 0.3% lidocaine HCl and 0.1% sodium metabisulfite
Elevess : Injectable gel, 0.5mL or 1.0mL material supplied in a 1.0mL pre-filled sterile glass syringe with two 30 gauge needles
|
|---|---|
|
Overall Study
STARTED
|
100
|
|
Overall Study
COMPLETED
|
96
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Elevess
Gel implant (dermal filler) composed of hyaluronan produced by Streptococcus equi (bacterial fermentation) that is cross-linked and suspended in phosphate buffered saline with 0.3% lidocaine HCl and 0.1% sodium metabisulfite
Elevess : Injectable gel, 0.5mL or 1.0mL material supplied in a 1.0mL pre-filled sterile glass syringe with two 30 gauge needles
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|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
Baseline Characteristics
Safety Study of Cosmetic Tissue Augmentation in People of Color
Baseline characteristics by cohort
| Measure |
Elevess
n=100 Participants
Gel implant (dermal filler) composed of hyaluronan produced by Streptococcus equi (bacterial fermentation) that is cross-linked and suspended in phosphate buffered saline with 0.3% lidocaine HCl and 0.1% sodium metabisulfite
Elevess : Injectable gel, 0.5mL or 1.0mL material supplied in a 1.0mL pre-filled sterile glass syringe with two 30 gauge needles
|
|---|---|
|
Age, Continuous
|
50.1 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
97 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
53 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 WeeksPopulation: Safety Population
Percentage of Subjects with keloid formation at the site of injection
Outcome measures
| Measure |
Elevess
n=97 Participants
Subjects that received injection(s) of Elevess and exhibited keloid formation.
|
|---|---|
|
Keloid Formation at Site of Injection
|
0.0 percentage of participants
|
PRIMARY outcome
Timeframe: 6 WeeksPopulation: Safety Population
Percentage of Subjects with keloid formation at the site of injection
Outcome measures
| Measure |
Elevess
n=97 Participants
Subjects that received injection(s) of Elevess and exhibited keloid formation.
|
|---|---|
|
Keloid Formation at Site of Injection
|
0.0 Percentage (%) of subjects
|
PRIMARY outcome
Timeframe: 12 WeeksPopulation: Safety Population
Percentage of Subjects with keloid formation at the site of injection
Outcome measures
| Measure |
Elevess
n=94 Participants
Subjects that received injection(s) of Elevess and exhibited keloid formation.
|
|---|---|
|
Keloid Formation at Site of Injection
|
0.0 Percentage (%) of subjects
|
PRIMARY outcome
Timeframe: 24 WeeksPopulation: Safety Population
Percentage of subjects with keloid formation at the site of injection at End of Study
Outcome measures
| Measure |
Elevess
n=98 Participants
Subjects that received injection(s) of Elevess and exhibited keloid formation.
|
|---|---|
|
Keloid Formation at Site of Injection
|
0.0 Percentage (%) of subjects
|
PRIMARY outcome
Timeframe: 2 WeeksPopulation: Safety Population
Percentage of Subjects with pigmentation changes at site of injection
Outcome measures
| Measure |
Elevess
n=97 Participants
Subjects that received injection(s) of Elevess and exhibited keloid formation.
|
|---|---|
|
Pigmentation Changes at Site of Injection
|
8.0 Percentage (%) of subjects
|
PRIMARY outcome
Timeframe: 6 WeeksPopulation: Safety Population
Percentage of Subjects with pigmentation changes at site of injection
Outcome measures
| Measure |
Elevess
n=97 Participants
Subjects that received injection(s) of Elevess and exhibited keloid formation.
|
|---|---|
|
Pigmentation Changes at Site of Injection
|
3.0 Percentage (%) of subjects
|
PRIMARY outcome
Timeframe: 12 WeeksPopulation: Safety Population
Percentage of Subjects with pigmentation changes at site of injection
Outcome measures
| Measure |
Elevess
n=94 Participants
Subjects that received injection(s) of Elevess and exhibited keloid formation.
|
|---|---|
|
Pigmentation Changes at Site of Injection
|
2.0 Percentage (%) of subjects
|
PRIMARY outcome
Timeframe: 24 WeeksPopulation: Safety Population
Percentage of subjects with pigmentation changes at site of injection at End of Study
Outcome measures
| Measure |
Elevess
n=98 Participants
Subjects that received injection(s) of Elevess and exhibited keloid formation.
|
|---|---|
|
Pigmentation Changes at Site of Injection
|
1.0 Percentage (%) of subjects
|
Adverse Events
Safety Population
Serious events: 0 serious events
Other events: 47 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Safety Population
n=100 participants at risk
All Subjects receiving treatment of nasolabial folds (NLF) with injection of Elevess.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
1.0%
1/100 • Number of events 1 • Adverse Events were recorded to 24 Weeks.
|
|
Ear and labyrinth disorders
Vertigo
|
1.0%
1/100 • Number of events 1 • Adverse Events were recorded to 24 Weeks.
|
|
Eye disorders
Eye Swelling
|
1.0%
1/100 • Number of events 1 • Adverse Events were recorded to 24 Weeks.
|
|
Gastrointestinal disorders
Lip Swelling
|
1.0%
1/100 • Number of events 1 • Adverse Events were recorded to 24 Weeks.
|
|
Gastrointestinal disorders
Dental Caries
|
1.0%
1/100 • Number of events 1 • Adverse Events were recorded to 24 Weeks.
|
|
Gastrointestinal disorders
Abdominal Pain
|
1.0%
1/100 • Number of events 1 • Adverse Events were recorded to 24 Weeks.
|
|
Gastrointestinal disorders
Nausea
|
2.0%
2/100 • Number of events 2 • Adverse Events were recorded to 24 Weeks.
|
|
General disorders
Injection Site Discoloration
|
10.0%
10/100 • Number of events 13 • Adverse Events were recorded to 24 Weeks.
|
|
General disorders
Injection Site Dryness
|
1.0%
1/100 • Number of events 1 • Adverse Events were recorded to 24 Weeks.
|
|
General disorders
Injection Site Erythema
|
3.0%
3/100 • Number of events 3 • Adverse Events were recorded to 24 Weeks.
|
|
General disorders
Injection Site Hematoma
|
1.0%
1/100 • Number of events 1 • Adverse Events were recorded to 24 Weeks.
|
|
General disorders
Injection Site Induration
|
5.0%
5/100 • Number of events 7 • Adverse Events were recorded to 24 Weeks.
|
|
General disorders
Injection Site Irritation
|
1.0%
1/100 • Number of events 7 • Adverse Events were recorded to 24 Weeks.
|
|
General disorders
Injection Site Nodule
|
4.0%
4/100 • Number of events 4 • Adverse Events were recorded to 24 Weeks.
|
|
General disorders
Injection Site Pain
|
4.0%
4/100 • Number of events 4 • Adverse Events were recorded to 24 Weeks.
|
|
General disorders
Injection Site Pruritus
|
1.0%
1/100 • Number of events 3 • Adverse Events were recorded to 24 Weeks.
|
|
General disorders
Injection Site Scab
|
1.0%
1/100 • Number of events 1 • Adverse Events were recorded to 24 Weeks.
|
|
General disorders
Injection Site Swelling
|
2.0%
2/100 • Number of events 2 • Adverse Events were recorded to 24 Weeks.
|
|
Infections and infestations
Bronchitis
|
1.0%
1/100 • Number of events 1 • Adverse Events were recorded to 24 Weeks.
|
|
Infections and infestations
Cystitis
|
1.0%
1/100 • Number of events 1 • Adverse Events were recorded to 24 Weeks.
|
|
Infections and infestations
Gastrointestinal Bacterial Infection
|
1.0%
1/100 • Number of events 1 • Adverse Events were recorded to 24 Weeks.
|
|
Infections and infestations
Helicobacter Pylori
|
1.0%
1/100 • Number of events 1 • Adverse Events were recorded to 24 Weeks.
|
|
Infections and infestations
Influenza
|
3.0%
3/100 • Number of events 3 • Adverse Events were recorded to 24 Weeks.
|
|
Infections and infestations
Nasopharyngitis
|
1.0%
1/100 • Number of events 1 • Adverse Events were recorded to 24 Weeks.
|
|
Infections and infestations
Pharyngitis
|
1.0%
1/100 • Number of events 1 • Adverse Events were recorded to 24 Weeks.
|
|
Infections and infestations
Sinusitis
|
4.0%
4/100 • Number of events 4 • Adverse Events were recorded to 24 Weeks.
|
|
Infections and infestations
Tooth Infection
|
1.0%
1/100 • Number of events 1 • Adverse Events were recorded to 24 Weeks.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
5.0%
5/100 • Number of events 6 • Adverse Events were recorded to 24 Weeks.
|
|
Injury, poisoning and procedural complications
Cartilage Injury
|
1.0%
1/100 • Number of events 1 • Adverse Events were recorded to 24 Weeks.
|
|
Injury, poisoning and procedural complications
Joint Sprain
|
1.0%
1/100 • Number of events 1 • Adverse Events were recorded to 24 Weeks.
|
|
Injury, poisoning and procedural complications
Ligament Injury
|
1.0%
1/100 • Number of events 1 • Adverse Events were recorded to 24 Weeks.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.0%
1/100 • Number of events 1 • Adverse Events were recorded to 24 Weeks.
|
|
Musculoskeletal and connective tissue disorders
Bunion
|
1.0%
1/100 • Number of events 1 • Adverse Events were recorded to 24 Weeks.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.0%
1/100 • Number of events 1 • Adverse Events were recorded to 24 Weeks.
|
|
Nervous system disorders
Dizziness
|
1.0%
1/100 • Number of events 1 • Adverse Events were recorded to 24 Weeks.
|
|
Nervous system disorders
Headache
|
5.0%
5/100 • Number of events 6 • Adverse Events were recorded to 24 Weeks.
|
|
Psychiatric disorders
Insomnia
|
1.0%
1/100 • Number of events 1 • Adverse Events were recorded to 24 Weeks.
|
|
Reproductive system and breast disorders
Breast Pain
|
1.0%
1/100 • Number of events 1 • Adverse Events were recorded to 24 Weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
1.0%
1/100 • Number of events 1 • Adverse Events were recorded to 24 Weeks.
|
|
Skin and subcutaneous tissue disorders
Acne
|
1.0%
1/100 • Number of events 2 • Adverse Events were recorded to 24 Weeks.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
1.0%
1/100 • Number of events 1 • Adverse Events were recorded to 24 Weeks.
|
|
Vascular disorders
Hypertension
|
1.0%
1/100 • Number of events 1 • Adverse Events were recorded to 24 Weeks.
|
|
Vascular disorders
Vasoconstriction
|
1.0%
1/100 • Number of events 1 • Adverse Events were recorded to 24 Weeks.
|
Additional Information
Adrian Orr, Director Clinical Affairs
Anika Therapeutics
Phone: 781.457.9000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60