AgingNCT00911872
EVOLENCE® Assessment of Recovery Time and Impact of Dermal Filler Selection: The E-ART™ Study
A study testing collagen (EVOLENCE) in people with Aging, run by Solish, Nowell, M.D. at 1 site in Canada.
Trial summary
The purpose of this study is to gather information about the immediate effects and recovery time for treatment with EVOLENCE/EVOLENCE BREEZE for soft tissue augmentation. The time it takes for patients to feel comfortable with the results, and return to their normal daily routine is also of important interest Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- collagen (EVOLENCE)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2008to Aug 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or Female > 18 years of age
- Need for soft tissue augmentation as evidenced by any of the following:
- Bilateral-aging defects > 1 on the Modified Fitzpatrick Wrinkle Scale
- Decrease in soft tissue volume in other areas of the face
Who cannot join
- History of positive hypersensitivity to porcine collagen-based products History of multiple food, drug, and substance allergies Autoimmune or collagen vascular disease Facial tissue augmentation within 6 months (HA) or 12 months Evolence/Evolence Breeze Botulinum-toxin A within 6 weeks Ablative laser treatments within 12 months Permanent facial implants Investigational product use within 30 days Pregnant and/or nursing woman or woman who plan to become pregnant during the study.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to gather information about the immediate effects and recovery time for treatment with EVOLENCE/EVOLENCE BREEZE for soft tissue augmentation. The time it takes for patients to feel comfortable with the results, and return to their normal daily routine is also of important interest
Read the detailed description
The primary objective of this Investigator Initiated Study is to document recovery time/return to daily activities following facial soft-tissue augmentation with an EVOLENCE dermal filler. In addition, the immediate effects such as swelling, bleeding, bruising will be assessed.
- Conditions
- Aging
- Being tested
- collagen (EVOLENCE)
- Keywords
- wrinkles, dermal filler, collagen, soft tissue augmentation, aesthetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collagen (EVOLENCE)Device
Also called EVOLENCE and EVOLENCE BREEZE
injectable collagen
| Study group | Role | What they receive |
|---|---|---|
| aging | Experimental | Not described Receives: Device: collagen (EVOLENCE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Is to document recovery time/return to daily activities following facial soft-tissue augmentation with an EVOLENCE dermal filler
Measured: 7 Days
Secondary outcomes (1)
the immediate effects such as swelling, bleeding, bruising will be assessed
Measured: 7 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2009 (estimated)
- Study startJan 2008
- Primary completionJun 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solish, Nowell, M.D.
- Investigators
- Nowell Solish, MD, Principal investigator, Private Practice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00911872
- Sponsor's protocol ID
- E-ART
- Status last verified
- May 2009
- First submitted
- 29 May 2009
- Last updated
- 2 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Solish NJ. Assessment of recovery time for the collagen products Dermicol-P35 27G and 30G. J Am Acad Dermatol. 2010 May;62(5):824-30. doi: 10.1016/j.jaad.2009.08.016.
PubMed 20398812
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVOLENCE® Assessment of Recovery Time and Impact of Dermal Filler Selection: The E-ART™ Study
- ClinicalTrials.gov ID
- NCT00911872
- Acronym / sponsor ID
- E-ART
- Conditions
- Aging
- Keywords
- wrinkles, dermal filler, collagen, soft tissue augmentation, aesthetic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Solish, Nowell, M.D.
- Study start
- Jan 2008
- Primary completion
- Jun 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 2 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to gather information about the immediate effects and recovery time for treatment with EVOLENCE/EVOLENCE BREEZE for soft tissue augmentation. The time it takes for patients to feel comfortable with the results, and return to their normal daily routine is also of important interest
Detailed description
The primary objective of this Investigator Initiated Study is to document recovery time/return to daily activities following facial soft-tissue augmentation with an EVOLENCE dermal filler. In addition, the immediate effects such as swelling, bleeding, bruising will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| aging | Experimental | Device: collagen (EVOLENCE) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or Female > 18 years of age
- Need for soft tissue augmentation as evidenced by any of the following:
Key exclusion criteria (1 listed)
- History of positive hypersensitivity to porcine collagen-based products History of multiple food, drug, and substance allergies Autoimmune or collagen vascular disease Facial tissue augmentation within 6 months (HA) or 12 months Evolence/Evolence Breeze Botulinum-toxin A within 6 weeks Ablative laser treatments within 12 months Permanent facial implants Investigational product use within 30 days Pregnant and/or nursing woman or woman who plan to become pregnant during the study.
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 |
|---|---|---|
| collagen (EVOLENCE)Also: EVOLENCE and EVOLENCE BREEZEinjectable collagen | Device | aging |
Primary outcome
Is to document recovery time/return to daily activities following facial soft-tissue augmentation with an EVOLENCE dermal filler
Time frame: 7 Days
1 secondary outcome
the immediate effects such as swelling, bleeding, bruising will be assessed
Time frame: 7 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2009.
- Derived from this study: PubMed 20398812Solish NJ. Assessment of recovery time for the collagen products Dermicol-P35 27G and 30G. J Am Acad Dermatol. 2010 May;62(5):824-30. doi: 10.1016/j.jaad.2009.08.016.
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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
Private Practice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing collagen (EVOLENCE) in people with Aging, run by Solish, Nowell, M.D. at 1 site 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 4 inclusion and 1 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 2 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Is to document recovery time/return to daily activities following facial soft-tissue augmentation with an EVOLENCE dermal filler (time frame: 7 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00911872, which also lists 1 linked publication.
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 2 Jun 2009; AzTrials last refreshed its copy on 8 Nov 2026.