Trial Outcomes & Findings for Safety Evaluation of Aline HA, an Implanted Cross-Linked HA Device (NCT NCT01708213)

Results Overview

The primary endpoint of this study is to assess treatment site responses and adverse events through 6 months post procedure.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

72 participants

Primary outcome timeframe

6 months

Results posted on

2014-12-17

Participant Flow

Participant milestones

Participant milestones
Measure	Dermal Filler - Aline HA Non-Randomized Aline HA: Implantable dermal filler
Overall Study STARTED	72
Overall Study COMPLETED	71
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety Evaluation of Aline HA, an Implanted Cross-Linked HA Device

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dermal Filler - Aline HA n=72 Participants Single armed study Aline HA: Implantable dermal filler
Age, Continuous	50.5 years n=93 Participants
Sex: Female, Male Female	64 Participants n=93 Participants
Sex: Female, Male Male	8 Participants n=93 Participants
Region of Enrollment Canada	72 participants n=93 Participants

PRIMARY outcome

Timeframe: 6 months

The primary endpoint of this study is to assess treatment site responses and adverse events through 6 months post procedure.

Outcome measures

Outcome measures
Measure	Dermal Filler - Aline HA n=72 Participants Non-Randomized Aline HA: Implantable dermal filler
Assessment of Treatment Site Responses Post Procedure	78 percentage of participants with any AE

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Dermal Filler - Aline HA n=10 Participants Non-Randomized Aline HA: Implantable dermal filler
Number of Participants With a Decrease in the Wrinkle Severity Scale for Nasolabial Folds	5 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Dermal Filler - Aline HA n=43 Participants Non-Randomized Aline HA: Implantable dermal filler
Percentage of Participants That Were Satisfied With the Treatment as Rated by GAIS	60 percentage of participants

Adverse Events

Dermal Filler - Aline HA

Serious events: 0 serious events

Other events: 56 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Dermal Filler - Aline HA n=72 participants at risk To evaluate the safety and performance of Aline HA to treat mild to severe wrinkles in adult subjects
General disorders Administration Site Conditions	73.6% 53/72 • 6 months As reported by the investigator or the subject
Nervous system disorders Headache	4.2% 3/72 • 6 months As reported by the investigator or the subject

Additional Information

Ann Thomas

TauTona Group

Phone: 650-331-2461

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place