Disorder of Soft TissueNCT01708213
Safety Evaluation of Aline HA, an Implanted Cross-Linked HA Device
A study testing Aline HA in people with Disorder of Soft Tissue, run by TauTona Group at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Disorder of Soft Tissue
- What is being tested?
- Aline HA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 2 sitesCanada
- Study dates
- Oct 2012to Dec 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The patient must be ≥ 21 and ≤ 70 years of age.
- The patient must be willing and able to provide informed consent.
- The patient must be able to read.
- The patient is willing and able to comply with the study protocol.
- The patient is seeking soft tissue augmentation
- The patient has a pre-treatment Wrinkle Severity Score (WSS) ≥ 2 for any NLF to be treated.
- The patient agrees to follow-up examinations out to 6 months post final treatment.
Who cannot join
- Exclusion Criteria: 1) The patient has had (or plans to have) cosmetic procedures to treat the intended treatment area, such as:
- Ablative or non-ablative resurfacing procedures including but not limited to medium depth or deeper chemical peeling, dermabrasion, laser resurfacing or fractional resurfacing that would affect the treatment area within the last 12 months.
- Laser or light based therapy that would affect the treatment area within the last 6 months.
- Face, neck or brow lift or other surgical procedure of the head and neck that would affect the treatment area in the last 18 months.
- Non-permanent dermal filler treatment in the treatment area within the last 9 months.
- Permanent implant or dermal filler treatment in the treatment area at any point in time.
Show all 13Show fewer
- Neurotoxin treatment that would affect the treatment area in the last 6 months, if the treatment area is below the eyes.
- Neurotoxin treatment that would affect the treatment area in the last 9 months, if the treatment area is above the eyes.
- 2) The patient has had or plans to use a pharmaceutical (topical or oral) anti-wrinkle product or other products (e.g., topical retinoids, hormone creams) affecting inflammation in the treatment area within 30 days of the study 3) The patient has inflammatory or infectious skin conditions or unhealed wounds in the treatment areas.
- 4) The patient has a cancerous or pre-cancerous lesion and/or has had radiation exposure in the treatment area in the last 24 months.
- 5) The patient has a history of anaphylaxis, multiple severe allergies, atopy, or is allergic to lidocaine or amide-based anesthetics, hyaluronic acid products, Streptococcal proteins or proteins from other gram positive organisms.
- 6) The patient has a history of significant bleeding disorders. 7) The patient has scleroderma or fibrotic tissue disease. 8) The patient is female and of child bearing potential and/or is pregnant or lactating or is not using medically effective birth control, such as hormonal methods in use at least 30 days prior to implantation, or barrier methods such as a condom and spermicide in use at least 14 days prior to implantation.
- 9) The patient is using a Legally Authorized Representative. 10) The patient is an employee or employee's family member of either the Study Sponsor or a Study Site.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
The Westmount Institute of Plastic Surgery
Montreal, Quebec, H3Z1B7
Dr. Nowell Solish
Toronto, Ontario, M5R3N8
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Disorder of Soft Tissue
- Being tested
- Aline HA
- Keywords
- soft tissue, augmentation, correction, wrinkles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aline HADevice
Implantable dermal filler
| Study group | Role | What they receive |
|---|---|---|
| Dermal Filler - Aline HA | Experimental | Single armed study Receives: Device: Aline HA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (2)
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
- - Just perceptible wrinkle
- - Shallow wrinkle
- - Moderately deep wrinkle
- - Deep wrinkle, well-defined edges
- - Very deep wrinkle, redundant fold
Measured: 6 months
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionNov 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Disorder of Soft TissueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- TauTona Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nowell Solish, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01708213
- Sponsor's protocol ID
- CP 10664
- Status last verified
- Dec 2014
- First submitted
- 12 Oct 2012
- Last updated
- 17 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01708213
- Acronym / sponsor ID
- CP 10664
- Conditions
- Disorder of Soft Tissue
- Keywords
- soft tissue, augmentation, correction, wrinkles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- TauTona GroupIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 16 Oct 2012 (estimated)
- Results
- Posted 17 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dermal Filler - Aline HA | Experimental | Device: Aline HASingle armed study |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The patient must be ≥ 21 and ≤ 70 years of age.
- The patient must be willing and able to provide informed consent.
- The patient must be able to read.
- The patient is willing and able to comply with the study protocol.
- The patient is seeking soft tissue augmentation
Key exclusion criteria (13 listed)
- Exclusion Criteria: 1) The patient has had (or plans to have) cosmetic procedures to treat the intended treatment area, such as:
- 2) The patient has had or plans to use a pharmaceutical (topical or oral) anti-wrinkle product or other products (e.g., topical retinoids, hormone creams) affecting inflammation in the treatment area within 30 days of the study 3) The patient has inflammatory or infectious skin conditions or unhealed wounds in the treatment areas.
- 4) The patient has a cancerous or pre-cancerous lesion and/or has had radiation exposure in the treatment area in the last 24 months.
- 5) The patient has a history of anaphylaxis, multiple severe allergies, atopy, or is allergic to lidocaine or amide-based anesthetics, hyaluronic acid products, Streptococcal proteins or proteins from other gram positive organisms.
- 6) The patient has a history of significant bleeding disorders. 7) The patient has scleroderma or fibrotic tissue disease. 8) The patient is female and of child bearing potential and/or is pregnant or lactating or is not using medically effective birth control, such as hormonal methods in use at least 30 days prior to implantation, or barrier methods such as a condom and spermicide in use at least 14 days prior to implantation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aline HAImplantable dermal filler | Device | Dermal Filler - Aline HA |
Primary outcome
Assessment of Treatment Site Responses Post Procedure
Time frame: 6 months
The primary endpoint of this study is to assess treatment site responses and adverse events through 6 months post procedure.
2 secondary outcomes
Number of Participants With a Decrease in the Wrinkle Severity Scale for Nasolabial Folds
Time frame: 6 months
Percentage of Participants That Were Satisfied With the Treatment as Rated by GAIS
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nowell Solish, MD principal investigator
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aline HA in people with Disorder of Soft Tissue, run by TauTona Group at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Treatment Site Responses Post Procedure (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2014.