Facial WrinklesNCT00407914
Safety and Effectiveness of Aquamid as Compared to Restylane for the Aesthetic Treatment of Nasolabial Folds
A study testing Aquamid and Restylane in people with Facial Wrinkles, run by Contura at 1 site in United States.
Trial summary
The purpose of this study is to compare the effectiveness of Aquamid and Restylane in aesthetically enhancing nasolabial folds 6 months after treatment and to evaluate the safety of Aquamid through 12 months after treatment. The study includes an extended follow up to 24 months. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Facial Wrinkles
- What is being tested?
- Aquamid and Restylane
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 315 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Jul 2009
- 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
- interested on soft tissue augmentation for the nasolabial folds
- moderate to severe nasolabial fold
Who cannot join
- sensitivity to anesthetics
- allergy to hyaluronic acid
- previous treatment with permanent fillers in the treated area
- recent previous aesthetic procedure in the treatment area
- infected skin areas or autoimmune diseases affecting the skin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Masked, Randomized, Multi-Center, 2-Arm Parallel Study Comparing the Safety and Effectiveness of Aquamid and Restylane for the Aesthetic Treatment of Nasolabial Folds
The purpose of this study is to compare the effectiveness of Aquamid and Restylane in aesthetically enhancing nasolabial folds 6 months after treatment and to evaluate the safety of Aquamid through 12 months after treatment.
The study includes an extended follow up to 24 months.
- Conditions
- Facial Wrinkles
- Being tested
- Aquamid, Restylane
- Keywords
- wrinkles, soft tissue filler, Aquamid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AquamidDevice
Subcutaneous injection
RestylaneDevice
Injection in dermis
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Aquamid Receives: Device: Aquamid |
| 2 | Active comparator | Restylane Receives: Device: Restylane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wrinkle Assessment Scale
Measured: Baseline, 3, 6, 9, 12 Months
Adverse device effects
Measured: continuosly
Secondary outcomes (3)
Global Aesthetic Improvement Scale
Measured: Optimal treatment, 3, 6, 9 and 12 Months
Injection site reactions
Measured: After injection
Adverse events
Measured: continuosly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2006 (estimated)
- Study startDec 2006
- Primary completionAug 2008
- Study completionJul 2009
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 Facial WrinklesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 315 participants (actual)
Sponsor and investigators
- Lead sponsor
- Contura
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Silvia Codony, Study director, Contura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00407914
- Sponsor's protocol ID
- CONAQ-US01
- Status last verified
- Oct 2009
- First submitted
- 4 Dec 2006
- Last updated
- 8 Oct 2009
- Results posted
- No
Publications
von Buelow S, von Heimburg D, Pallua N. Efficacy and safety of polyacrylamide hydrogel for facial soft-tissue augmentation. Plast Reconstr Surg. 2005 Sep 15;116(4):1137-46; discussion 1147-8. doi: 10.1097/01.prs.0000179349.14392.a4.
PubMed 16163108
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Masked, Randomized, Multi-Center, 2-Arm Parallel Study Comparing the Safety and Effectiveness of Aquamid and Restylane for the Aesthetic Treatment of Nasolabial Folds
- ClinicalTrials.gov ID
- NCT00407914
- Acronym / sponsor ID
- CONAQ-US01
- Conditions
- Facial Wrinkles
- Keywords
- wrinkles, soft tissue filler, Aquamid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 315 participants (actual)
- Lead sponsor
- ConturaIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Aug 2008 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 5 Dec 2006 (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 compare the effectiveness of Aquamid and Restylane in aesthetically enhancing nasolabial folds 6 months after treatment and to evaluate the safety of Aquamid through 12 months after treatment.
The study includes an extended follow up to 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: AquamidAquamid |
| 2 | Active comparator | Device: RestylaneRestylane |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- interested on soft tissue augmentation for the nasolabial folds
- moderate to severe nasolabial fold
Key exclusion criteria (5 listed)
- sensitivity to anesthetics
- allergy to hyaluronic acid
- previous treatment with permanent fillers in the treated area
- recent previous aesthetic procedure in the treatment area
- infected skin areas or autoimmune diseases affecting the skin
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 |
|---|---|---|
| AquamidSubcutaneous injection | Device | 1 |
| RestylaneInjection in dermis | Device | 2 |
Primary outcome
Wrinkle Assessment Scale
Time frame: Baseline, 3, 6, 9, 12 Months
Adverse device effects
Time frame: continuosly
3 secondary outcomes
Global Aesthetic Improvement Scale
Time frame: Optimal treatment, 3, 6, 9 and 12 Months
Injection site reactions
Time frame: After injection
Adverse events
Time frame: continuosly
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 8 Oct 2009.
- Background: PubMed 16163108von Buelow S, von Heimburg D, Pallua N. Efficacy and safety of polyacrylamide hydrogel for facial soft-tissue augmentation. Plast Reconstr Surg. 2005 Sep 15;116(4):1137-46; discussion 1147-8. doi: 10.1097/01.prs.0000179349.14392.a4.
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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.
Silvia Codony study director
Contura
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aquamid and Restylane in people with Facial Wrinkles, run by Contura at 1 site in United States.
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 2 inclusion and 5 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 8 Oct 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 United States. 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?
Wrinkle Assessment Scale (time frame: Baseline, 3, 6, 9, 12 Months). The study lists 2 primary outcomes in all. 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 NCT00407914, 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 8 Oct 2009.