Peri-oral WrinklesPhase 4NCT00977704
Study of Restylane and Perlane in the Correction of Peri-Oral Wrinkles
A Phase 4 study testing Restylane and Perlane in people with Peri-oral Wrinkles, run by Medicis Global Service Corporation at 2 sites in United States.
Trial summary
This is an open-label study to assess safety using Restylane and Perlane in the correction of facial wrinkles. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Peri-oral Wrinkles
- What is being tested?
- Restylane and Perlane
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2009to Dec 2009
- Phase
- Phase 4
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Same Wrinkle Severity (either both Moderate [3] or both Severe [4]) of marionette lines and upper peri-oral rhytids
Who cannot join
- Active or chronic skin disease, inflammation or related conditions, near or on the Nasolabial Folds
- Subjects who had undergone procedures based on active dermal response (e.g., laser or chemical peeling procedures) within 6 months prior to study entry
- Use of any facial tissue augmenting therapy with non-permanent filler or aesthetic facial surgical therapy within 9 months prior to study entry
- Permanent implant placed in the Nasolabial Fold area
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Call For Information
Coral Gables, Florida, 33146
Call For Information
Dallas, Texas, 75254
About this study
Official title: An Open-label Study of the Safety of Restylane and Perlane in the Correction of Peri-oral Wrinkles.
This is an open-label study to assess safety using Restylane and Perlane in the correction of facial wrinkles.
- Conditions
- Peri-oral Wrinkles
- Being tested
- Restylane and Perlane
- Keywords
- Correction of peri-oral wrinkles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restylane and PerlaneDevice
| Study group | Role | What they receive |
|---|---|---|
| Restylane and Perlane | Active comparator | Restylane and Perlane administered by injection. Recommended volume of 6.0 mL. Injection on study day 1 with an optional touch up on study day 14. Receives: Device: Restylane and Perlane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local and Systemic Adverse Events
To examine the safety of Restylane and Perlane when used in the treatment of facial wrinkles and folds by identification of the point incidence of:
- All local adverse events as reported by healthcare professional
- All systemic adverse events (related and unrelated)
Measured: 2-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionNov 2009
- Study completionDec 2009
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 Peri-oral 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medicis Global Service Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mary Sanstead, RN, BSN, CCRC, Study chair, Medicis Global Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00977704
- Sponsor's protocol ID
- MA-1900-01
- Status last verified
- May 2013
- First submitted
- 14 Sep 2009
- Last updated
- 10 Jun 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Study of the Safety of Restylane and Perlane in the Correction of Peri-oral Wrinkles.
- ClinicalTrials.gov ID
- NCT00977704
- Acronym / sponsor ID
- MA-1900-01
- Conditions
- Peri-oral Wrinkles
- Keywords
- Correction of peri-oral wrinkles
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Medicis Global Service CorporationIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 16 Sep 2009 (estimated)
- Results
- Posted 10 Jun 2013
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-label study to assess safety using Restylane and Perlane in the correction of facial wrinkles.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Restylane and Perlane | Active comparator | Device: Restylane and PerlaneRestylane and Perlane administered by injection. Recommended volume of 6.0 mL. Injection on study day 1 with an optional touch up on study day 14. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Same Wrinkle Severity (either both Moderate [3] or both Severe [4]) of marionette lines and upper peri-oral rhytids
Key exclusion criteria (4 listed)
- Active or chronic skin disease, inflammation or related conditions, near or on the Nasolabial Folds
- Subjects who had undergone procedures based on active dermal response (e.g., laser or chemical peeling procedures) within 6 months prior to study entry
- Use of any facial tissue augmenting therapy with non-permanent filler or aesthetic facial surgical therapy within 9 months prior to study entry
- Permanent implant placed in the Nasolabial Fold area
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 and Perlane | Device | Restylane and Perlane |
Primary outcome
Local and Systemic Adverse Events
Time frame: 2-weeks
To examine the safety of Restylane and Perlane when used in the treatment of facial wrinkles and folds by identification of the point incidence of: * All local adverse events as reported by healthcare professional * All systemic adverse events (related and unrelated)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Mary Sanstead, RN, BSN, CCRC study chair
Medicis Global Services
2 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 and Perlane in people with Peri-oral Wrinkles, run by Medicis Global Service Corporation at 2 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 1 inclusion and 4 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 10 Jun 2013. 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 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?
Yes. Results are posted in the registry (first posted 10 Jun 2013). 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?
Local and Systemic Adverse Events (time frame: 2-weeks). 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 10 Jun 2013.