Nasolabial FoldsNCT02179736
A Post Market Evaluation After Treatment of Nasolabial Folds
A study testing Restylane in people with Nasolabial Folds, run by Galderma R&D at 1 site in China.
Trial summary
This is an open, non-comparative study to evaluate effectiveness and safety of Restylane in correction of nasolabial folds up to 12 months after the initial treatment, and to evaluate the safety of repeat treatment of the nasolabial folds 12 months after the initial treatment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nasolabial Folds
- What is being tested?
- Restylane
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteChina
- Study dates
- Jul 2014to Jan 2016
- 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
- 18 years or older
- Intent to undergo correction of both nasolabial folds
- WRSR 3-4
- Signed informed consent
Who cannot join
- Markedly indurate defects such as significant mid-face volume loss or prominent commissures.
- Active skin disease, inflammation or related conditions, such as infection, psoriasis and herpes zoster near or in the area to be treated.
- Subjects with known hypersensitivity to any ingredient of the study product or anaesthesia used in the study.
- Concomitant anticoagulant therapy and therapy with inhibitors of platelet aggregation, (e.g. non-steriodal anti-inflammatory drugs, acetylsalicylic acid, Omega 3 and Vitamin E) within 2 weeks prior to treatment, or a history of bleeding disorders.
- Concomitant treatment with chemotherapy, immunosuppressive agents, immunomodulatory therapy (e.g. monoclonal antibodies), systemic or topical (facial) corticosteroids. (Inhaled corticoids are allowed).
- Cancerous or pre-cancerous lesions in the treatment area.
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- Subjects who have performed aesthetic facial surgery.
- Tissue augmenting therapy with non-permanent filler or neurotoxin below the lower orbital rim in the last 12 months.
- Facial laser treatment or chemical peeling below the lower orbital rim during the last 6 months.
- Permanent implant or filler, including fat-injections, placed in the area to be treated.
- Women who are pregnant or breast feeding or who are planning to become pregnant during the study period.
- Participation in any other clinical study within 30 days prior to inclusion.
- Any medical condition that in the opinion of the investigator would make the subject unsuitable for inclusion (e.g. a chronic, relapsing or hereditary disease that may affect the general condition or may require frequent medical treatment, psychiatric disorders or subjects not likely to comply to study procedures or to avoid other facial cosmetic treatments below the lower orbital rim).
- Subjects who are study site staff for this study, or close relatives (defined as parents, siblings, children or spouse) of the study site staff, as well as subjects who are employed by the sponsor company, or close relatives of employees at the sponsor company.
Trial locations and contacts
1 site in 1 country.
China1 site
Plastic Surgery InstituteNo
No. 33 Badachu Road, Shijingshan District, Beijing Municipality
About this study
This is an open, non-comparative study to evaluate effectiveness and safety of Restylane in correction of nasolabial folds up to 12 months after the initial treatment, and to evaluate the safety of repeat treatment of the nasolabial folds 12 months after the initial treatment.
- Conditions
- Nasolabial Folds
- Being tested
- Restylane
- Keywords
- Correction of moderate to severe nasolabial folds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RestylaneDevice
| Study group | Role | What they receive |
|---|---|---|
| Active treatment | Experimental | Not described Receives: Device: Restylane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of study treatment in correction of nasolabial folds up to 12 months after a single treatment:
- Investigator evaluated wrinkle severity using wrinkle severity rating scale (WSRS)
- Improvement in subject and investigator rated global aesthetic improvement (GAIS) compared to baseline.
- Subject satisfaction
Measured: up to 12 months
Secondary outcomes (1)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Safety of study treatment after single and repeat treatment of nasolabial folds will be assessed by:
- Local tolerability (reported by subjects in a 14-day diary)
- Adverse Events
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasolabial FoldsStudies of the same condition, open and under way.
- More trials run by Galderma R&DThe sponsor's other registered studies.
- 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
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02179736
- Sponsor's protocol ID
- 05DF1312
- Status last verified
- Feb 2015
- First submitted
- 19 Jun 2014
- Last updated
- 25 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post Market Evaluation After Treatment of Nasolabial Folds
- ClinicalTrials.gov ID
- NCT02179736
- Acronym / sponsor ID
- 05DF1312
- Conditions
- Nasolabial Folds
- Keywords
- Correction of moderate to severe nasolabial folds
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 2 Jul 2014 (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.
This is an open, non-comparative study to evaluate effectiveness and safety of Restylane in correction of nasolabial folds up to 12 months after the initial treatment, and to evaluate the safety of repeat treatment of the nasolabial folds 12 months after the initial treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active treatment | Experimental | Device: Restylane |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or older
- Intent to undergo correction of both nasolabial folds
- WRSR 3-4
- Signed informed consent
Key exclusion criteria (14 listed)
- Markedly indurate defects such as significant mid-face volume loss or prominent commissures.
- Active skin disease, inflammation or related conditions, such as infection, psoriasis and herpes zoster near or in the area to be treated.
- Subjects with known hypersensitivity to any ingredient of the study product or anaesthesia used in the study.
- Concomitant anticoagulant therapy and therapy with inhibitors of platelet aggregation, (e.g. non-steriodal anti-inflammatory drugs, acetylsalicylic acid, Omega 3 and Vitamin E) within 2 weeks prior to treatment, or a history of bleeding disorders.
- Concomitant treatment with chemotherapy, immunosuppressive agents, immunomodulatory therapy (e.g. monoclonal antibodies), systemic or topical (facial) corticosteroids. (Inhaled corticoids are allowed).
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 |
|---|---|---|
| Restylane | Device | Active treatment |
Primary outcome
Effectiveness of study treatment in correction of nasolabial folds up to 12 months after a single treatment:
Time frame: up to 12 months
* Investigator evaluated wrinkle severity using wrinkle severity rating scale (WSRS) * Improvement in subject and investigator rated global aesthetic improvement (GAIS) compared to baseline. * Subject satisfaction
1 secondary outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: Up to 12 months
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 25 Aug 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Restylane in people with Nasolabial Folds, run by Galderma R&D at 1 site in China.
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 14 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 25 Aug 2022. 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 China. 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?
Effectiveness of study treatment in correction of nasolabial folds up to 12 months after a single treatment: (time frame: up to 12 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 25 Aug 2022.