Disorder of Soft Tissue
Conditions
Keywords
soft tissue, augmentation, correction, wrinkles
Brief summary
The protocol hypothesis is that treatment with Aline HA™ will be safe through 6 months as determined by clinical assessment of treatment sites and routine tracking of adverse events.
Detailed description
A multi-center, open-label, prospective study of implanted cross-linked HA device, Aline HA, for soft tissue augmentation, to treat only one anatomic feature in up to 100 subjects for 6 months.
Interventions
DEVICEAline HA
Implantable dermal filler
Sponsors
TauTona Group
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. The patient must be ≥ 21 and ≤ 70 years of age. 2. The patient must be willing and able to provide informed consent. 3. The patient must be able to read. 4. The patient is willing and able to comply with the study protocol. 5. The patient is seeking soft tissue augmentation 6. The patient has a pre-treatment Wrinkle Severity Score (WSS) ≥ 2 for any NLF to be treated. 7. The patient agrees to follow-up examinations out to 6 months post final treatment.
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Treatment Site Responses Post Procedure | 6 months | The primary endpoint of this study is to assess treatment site responses and adverse events through 6 months post procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Decrease in the Wrinkle Severity Scale for Nasolabial Folds | 6 months | For this study, a decrease (at least one point) in the rating, relative to pre-treatment rating, when assessed by Investigators at the 1-Month, 3-Month, and 6-Month visits was considered clinically significant (P value less than 0.05). WSS: (0) - No wrinkle 1. \- Just perceptible wrinkle 2. \- Shallow wrinkle 3. \- Moderately deep wrinkle 4. \- Deep wrinkle, well-defined edges 5. \- Very deep wrinkle, redundant fold |
| Percentage of Participants That Were Satisfied With the Treatment as Rated by GAIS | 6 months | This was measured using the Global Aesthetic Improvement Scale (GAIS). With the Global Aesthetic Improvement Scale (GAIS Scale) results of 1, 2 and 3 at 6 months were considered satisfied in this study. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dermal Filler - Aline HA Single armed study
Aline HA: Implantable dermal filler | 72 |
| Total | 72 |
Baseline characteristics
| Characteristic | Dermal Filler - Aline HA |
|---|---|
| Age, Continuous | 50.5 years |
| Region of Enrollment Canada | 72 participants |
| Sex: Female, Male Female | 64 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 56 / 72 |
| serious Total, serious adverse events | 0 / 72 |
Outcome results
Primary
Assessment of Treatment Site Responses Post Procedure
The primary endpoint of this study is to assess treatment site responses and adverse events through 6 months post procedure.
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dermal Filler - Aline HA | Assessment of Treatment Site Responses Post Procedure | 78 percentage of participants with any AE |
Secondary
Number of Participants With a Decrease in the Wrinkle Severity Scale for Nasolabial Folds
For this study, a decrease (at least one point) in the rating, relative to pre-treatment rating, when assessed by Investigators at the 1-Month, 3-Month, and 6-Month visits was considered clinically significant (P value less than 0.05). WSS: (0) - No wrinkle 1. \- Just perceptible wrinkle 2. \- Shallow wrinkle 3. \- Moderately deep wrinkle 4. \- Deep wrinkle, well-defined edges 5. \- Very deep wrinkle, redundant fold
Time frame: 6 months
Population: Wrinkle Severity Score (WSS) assessment values of the Nasolabial Folds treatment area for the Per Protocol population (N=10) is a subgroup of the N=43 per protocol subjects treated. Reporting on the subjects with a 1 point improvement on the WSS at 6 months time.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dermal Filler - Aline HA | Number of Participants With a Decrease in the Wrinkle Severity Scale for Nasolabial Folds | 5 participants |
p-value: <0.05Parametric testing
Secondary
Percentage of Participants That Were Satisfied With the Treatment as Rated by GAIS
This was measured using the Global Aesthetic Improvement Scale (GAIS). With the Global Aesthetic Improvement Scale (GAIS Scale) results of 1, 2 and 3 at 6 months were considered satisfied in this study.
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dermal Filler - Aline HA | Percentage of Participants That Were Satisfied With the Treatment as Rated by GAIS | 60 percentage of participants |