RhytidsPhase 4NCT00765583
A Study to Determine How Long Restylane® Will Last After Initial Treatment With 2 Different Re-treatment Schedules.
A Phase 4 study testing Restylane in people with Rhytids, run by Medicis Aesthetics, Inc. at 3 sites in United States.
Trial summary
A total of 75 subjects will be enrolled into a 36 month study. Subjects will be treated with Restylane® on both sides of the face (nasolabial folds) at the first visit, on one side of the face at month 4.5 and on the other side of the face at month 9. Both sides of the face will then be treated again at month 18. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rhytids
- What is being tested?
- Restylane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2005to Feb 2009
- Phase
- Phase 4
- 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
- Males or non-pregnant, non-breast feeding females aged 18 years or older.
- Subjects seeking augmentation therapy for correction of bilateral nasolabial folds.
- Subjects with a score of 3 or 4 on the Severity Rating Scale.
- Subjects with the ability to understand and comply with the requirements of the trial.
- Subjects willing to abstain from exclusionary procedures (e.g., further augmentation therapy,laser or chemical resurfacing; Botox® injections below eye level; facelift)for the duration of the study.
- Subjects willing to give written informed consent to participate in the trial.
- Women of childbearing potential must be willing to use an acceptable form of birth control during the study period.
Who cannot join
- Active or chronic skin disease, inflammation or related conditions, such as infection, psoriasis and herpes zoster near or on the nasolabial folds.
- Patients that have undergone procedures based on active dermal response (e.g. laser and chemical peeling procedures), within 6 months prior to study entry.
- Use of any facial tissue augmenting therapy or aesthetic facial surgical therapy within nine (9)months prior to study entry, e.g. injection or other form of implantation of tissue augmenting substances, Botox injections below the level of the eye-brows, facelift.
- Concomitant anticoagulant therapy, antiplatelet therapy, or a history of bleeding disorders.
- Patients who have previously experienced unanticipated adverse reactions when treated with hyaluronic acid based products.
- Any condition which in the opinion of the investigator makes the patient unsuitable for inclusion (e.g., patients not likely to avoid other treatments, patients not likely to stay in the study for six months, or patients anticipated to be unreliable).
- Subjects with cancerous or pre-cancerous lesions in the area to be treated.
- Use of any investigational drugs or devices within 30 days prior to randomization.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Dayan Facial Plastic Surgery Institute
Chicago, Illinois, 60611
Dermatology Research Institute, LLC
Coral Gables, Florida, 33146
Rhoda Narins, MD
White Plains, New York, 10604
About this study
Official title: A Randomized, Evaluator-Blind, Multi-Center, Comparison of the Efficacy and Persistence of Correction of Nasolabial Folds With Restylane® Using Two Different Re-Treatment Schedules
A total of 75 subjects will be enrolled into a 36 month study. Subjects will be treated with Restylane® on both sides of the face (nasolabial folds) at the first visit, on one side of the face at month 4.5 and on the other side of the face at month 9. Both sides of the face will then be treated again at month 18. The subjects will evaluate themselves and will also be evaluated by the treating doctor and a blinded evaluator (a person that does not know when the different sides of the face are treated). Side effects and medications taken during the study will also be recorded.
Read the detailed description
The study will employ a randomized, evaluator-blind design. One of the nasolabial folds will be randomly assigned to be corrected with Restylane and then re-treated at 4 ½ months. The opposite side will be treated with Restylane and not re-treated until 9 months. Both nasolabial folds will be re-treated at 18 months. Each subject will serve as their own control, allowing comparison of the outcome between the contralateral sides.
This is a multi-center U.S. trial with a planned enrollment of 75 subjects at three centers. The goal of the study is to enroll and complete follow-up for 60 evaluable subjects. In order to compensate for early discontinuations, a total of at least 75 subjects will be recruited and treated.
After giving written informed consent, potential study participants will undergo a screening evaluation and initial treatment (Visit 1). The two nasolabial folds will be randomized for treatment so that one side will be designated for re-treatment with Restylane at 4 ½ months; the other at 9 months. At month 18 (Visit 7) both nasolabial folds will be re-treated. Follow-up visits will be scheduled through 36 months after initial treatment or touch-up.
- Conditions
- Rhytids
- Being tested
- Restylane
- Keywords
- Wrinkles (Nasolabial Folds)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RestylaneDrug
Treatment of the nasolabial folds with Restylane at Day 0/Baseline, Month 4.5, Month 9 and Month 18.
| Study group | Role | What they receive |
|---|---|---|
| restylane | Experimental | Restylane arm with different re-treatment schedules Receives: Drug: Restylane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blinded Evaluator Wrinkle Severity Rating Scale (WSRS) scores at month 18.
Measured: 18 months
Secondary outcomes (1)
Subject and Blinded Evaluator WSRS scores at all other time points and Treating Investigator and Subject Global Aesthetic Improvement Scores (GAIS) at all time points.
Measured: Through end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2008 (estimated)
- Study startNov 2005
- Primary completionDec 2008
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhytidsStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medicis Aesthetics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fredric Brandt, MD, Principal investigator, Dermatology Research Institute, LLCSteven Dayan, MD, Principal investigator, Steven Dayan, MDRhoda narins, MD, Principal investigator, Rhoda narins, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00765583
- Sponsor's protocol ID
- MA-04-003
- Other IDs
- MA-04-003
- Status last verified
- Sep 2011
- First submitted
- 1 Oct 2008
- Last updated
- 22 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Evaluator-Blind, Multi-Center, Comparison of the Efficacy and Persistence of Correction of Nasolabial Folds With Restylane® Using Two Different Re-Treatment Schedules
- ClinicalTrials.gov ID
- NCT00765583
- Acronym / sponsor ID
- MA-04-003
- Conditions
- Rhytids
- Keywords
- Wrinkles (Nasolabial Folds)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Medicis Aesthetics, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Dec 2008 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 3 Oct 2008 (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.
A total of 75 subjects will be enrolled into a 36 month study. Subjects will be treated with Restylane® on both sides of the face (nasolabial folds) at the first visit, on one side of the face at month 4.5 and on the other side of the face at month 9. Both sides of the face will then be treated again at month 18. The subjects will evaluate themselves and will also be evaluated by the treating doctor and a blinded evaluator (a person that does not know when the different sides of the face are treated). Side effects and medications taken during the study will also be recorded.
Detailed description
The study will employ a randomized, evaluator-blind design. One of the nasolabial folds will be randomly assigned to be corrected with Restylane and then re-treated at 4 ½ months. The opposite side will be treated with Restylane and not re-treated until 9 months. Both nasolabial folds will be re-treated at 18 months. Each subject will serve as their own control, allowing comparison of the outcome between the contralateral sides.
This is a multi-center U.S. trial with a planned enrollment of 75 subjects at three centers. The goal of the study is to enroll and complete follow-up for 60 evaluable subjects. In order to compensate for early discontinuations, a total of at least 75 subjects will be recruited and treated.
After giving written informed consent, potential study participants will undergo a screening evaluation and initial treatment (Visit 1). The two nasolabial folds will be randomized for treatment so that one side will be designated for re-treatment with Restylane at 4 ½ months; the other at 9 months. At month 18 (Visit 7) both nasolabial folds will be re-treated. Follow-up visits will be scheduled through 36 months after initial treatment or touch-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| restylane | Experimental | Drug: RestylaneRestylane arm with different re-treatment schedules |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males or non-pregnant, non-breast feeding females aged 18 years or older.
- Subjects seeking augmentation therapy for correction of bilateral nasolabial folds.
- Subjects with a score of 3 or 4 on the Severity Rating Scale.
- Subjects with the ability to understand and comply with the requirements of the trial.
- Subjects willing to abstain from exclusionary procedures (e.g., further augmentation therapy,laser or chemical resurfacing; Botox® injections below eye level; facelift)for the duration of the study.
Key exclusion criteria (8 listed)
- Active or chronic skin disease, inflammation or related conditions, such as infection, psoriasis and herpes zoster near or on the nasolabial folds.
- Patients that have undergone procedures based on active dermal response (e.g. laser and chemical peeling procedures), within 6 months prior to study entry.
- Use of any facial tissue augmenting therapy or aesthetic facial surgical therapy within nine (9)months prior to study entry, e.g. injection or other form of implantation of tissue augmenting substances, Botox injections below the level of the eye-brows, facelift.
- Concomitant anticoagulant therapy, antiplatelet therapy, or a history of bleeding disorders.
- Patients who have previously experienced unanticipated adverse reactions when treated with hyaluronic acid based products.
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 |
|---|---|---|
| RestylaneTreatment of the nasolabial folds with Restylane at Day 0/Baseline, Month 4.5, Month 9 and Month 18. | Drug | restylane |
Primary outcome
Blinded Evaluator Wrinkle Severity Rating Scale (WSRS) scores at month 18.
Time frame: 18 months
1 secondary outcome
Subject and Blinded Evaluator WSRS scores at all other time points and Treating Investigator and Subject Global Aesthetic Improvement Scores (GAIS) at all time points.
Time frame: Through end of study
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 22 Sep 2011.
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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.
Fredric Brandt, MD principal investigator
Dermatology Research Institute, LLC
Steven Dayan, MD principal investigator
Steven Dayan, MD
Rhoda narins, MD principal investigator
Rhoda narins, MD
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Restylane in people with Rhytids, run by Medicis Aesthetics, Inc. at 3 sites 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 7 inclusion and 8 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 22 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Blinded Evaluator Wrinkle Severity Rating Scale (WSRS) scores at month 18. (time frame: 18 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 22 Sep 2011.