Perioral RhytidsPhase 4NCT02818556
A Clinical Study Comparing Restylane® Silk and Belotero Balance® for the Treatment of Superficial, Vertical Perioral Lines
A Phase 4 study testing Restalyne Silk and Belotero Balance in people with Perioral Rhytids, run by The Maas Clinic at 1 site in United States.
Trial summary
This will be a single-center, randomized, evaluator-blinded, split-face clinical study design. Fifty patients will receive one treatment session consisting of Restylane® Silk (right side of the face) and Belotero Balance® (left side), or vice versa (1:1 dose conversion ratio) injections to the superficial, vertical… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Perioral Rhytids
- What is being tested?
- Restalyne Silk and Belotero Balance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Jan 2017
- 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
- Patients exhibiting moderate [2] to severe [3] superficial, vertical perioral lines on the 5-point Merz® validated scale for assessment of superficial perioral lines
- Females and males in good general health over the age of 18 years old
- Must be willing to give and sign a HIPAA form, informed consent form and a photographic release form
- Patient is planning to undergo Restylane® Silk and Belotero Balance® injections
- For female patient of childbearing potential, must have had a regular menstrual cycle prior to study entry (a female is considered of childbearing potential unless she is postmenopausal, without a uterus and/or both ovaries, or has had a bilateral tubal ligation) and is willing to use an acceptable form of birth control during the entire course of the study [i.e., acceptable methods of birth control are oral contraceptives, contraceptive patches/rings/implants Norplanit®, Depo-Provena®, double-barrier methods (e.g. condoms and spermicide), abstinence and vasectomies of partner with a documented second acceptable method of birth control should the patient become sexually active]. All systemic birth control measures must be in consistent use at least 30 days prior to study participation
- Negative urine pregnancy test results at the time of study entry (if applicable)
- Must be willing to comply with study regimen and complete the entire course of the study.
Who cannot join
- A patient with any uncontrolled systemic disease. A potential patient in whom therapy for a systemic disease is not yet stabilized will not be considered for entry into the study
- A patient with a significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study.
- A patient with a known hypersensitivity to any of the components of the study medications
- A patient who is actively smoking or plans to smoke at any time of the duration of this study
- A patient with an active skin condition/disease that might interfere with the diagnosis or evaluation of study parameters (i.e., atopic dermatitis, eczema, psoriasis, seborrheic dermatitis, herpes labialis)
- A patient planning any other cosmetic procedure to their facial area during the study period, other than the treatments that will be performed by the investigator
Show all 17Show fewer
- A patient using any topical (prescription or over the counter) medicated creams, lotions, gels, balms, powders, etc. on the treatment areas during the study period
- A patient receiving any topical products containing alpha-hydroxy acids, salicylic acid, and vitamins C or D (includes derivatives thereof) on the perioral areas within 7 days prior to or during the study period, other than the study products
- A patient receiving any investigational drug and/or has had a microdermabrasion (light or medium skin peel) treatment on their perioral areas within 30 days prior to or during the study period
- A patient using any topical tretinoin product or derivative on their perioral areas within 12 weeks prior to or during the study period
- A patient receiving a chemical peel, any systemic steroids, a non-ablative laser, light or radio frequency treatment and/or has had a dermabrasion (deep skin peel) or ablative laser treatments on their perioral areas must have discontinued the drug/treatment and/or had the procedure at least 6 months prior to entering the study
- A patient that has previously been treated with botulinum toxin in the perioral areas within the past six months
- A patient that has previously been treated with dermal filler in the perioral areas within the past year
- A patient that with a history of allergic reaction to a dermal filler or lidocaine
- A patient that with a history of a permanent filler to the perioral areas
- A female patient who is pregnant, nursing an infant or planning a pregnancy during the study [throughout the course of the study, women of child-bearing potential must use reliable forms of contraception (i.e., oral contraceptive, intrauterine device, abstinence, or spermicides and condoms used in combination)]
- Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
The Maas Clinic
San Francisco, California, 94115
Rachel Bass, B.S., 415-567-8275, research@maasclinic.com
Kyle Jennings, B.S, 415-567-7000, research2@maasclinic.com
About this study
This will be a single-center, randomized, evaluator-blinded, split-face clinical study design. Fifty patients will receive one treatment session consisting of Restylane® Silk (right side of the face) and Belotero Balance® (left side), or vice versa (1:1 dose conversion ratio) injections to the superficial, vertical perioral lines. Injections will be performed at the baseline visit. To ensure subject and investigator blinding, syringes will be prepared and labeled "1" and "2" immediately before subject attendance for injection by the sub-investigator. The same injection sites and techniques will be used on both sides of the face. Then, patients will follow-up on post-treatment day 7, 14, 30, 60, 90, 120, 150, 180.
- Conditions
- Perioral Rhytids
- Being tested
- Restalyne Silk, Belotero Balance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restalyne SilkDrug
Belotero BalanceDrug
| Study group | Role | What they receive |
|---|---|---|
| Restylane Right, Belotero Left | Other | Patients will receive one treatment with Restylane® Silk (right side of the face) and one treatment of Belotero Balance® (left side) Receives: Drug: Restalyne Silk; Drug: Belotero Balance |
| Restylane Left, Belotero Right | Other | Patients will receive one treatment with Restylane® Silk (left side of the face) and one treatment of Belotero Balance® (right side) Receives: Drug: Restalyne Silk; Drug: Belotero Balance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Response to therapy as evaluated by investigator using 5-point Merz® Scale
Response to therapy on each side of the lip on day 0 (initial treatment), and subsequent post-treatment days 7, 14, 30, 60, 90, 120, 150, 180, as measured by the blinded evaluator: A 1-point improvement from baseline in superficial, vertical, perioral rhytids based on the 5-point Merz® Scale
Measured: Day 0, 7, 14, 30, 60, 90, 120, 150, 180
Secondary outcomes (3)
Response to Therapy- Subject
Response to therapy on each side of the lip on day 0 (initial treatment), and subsequent post-treatment days 7, 14, 30, 60, 90, 120, 150, 180, as measured by the blinded patient: A 20% improvement from baseline in superficial, vertical, perioral rhytids using a linear analog scale
Measured: Day 0, 7, 14, 30, 60, 90, 120, 150, 180
Severity grading- Evaluator
Severity grading by a blinded evaluator employing standardized photography in combination with the 5-point Merz® Scale
Measured: 6 months
VISIA complexion analysis
VISIA complexion analysis (Canfield Imaging Systems, Fairfield, New Jersey) on day 0 (initial treatment), day 30 and when the patient's perioral fine lines have returned to baseline. VISIA analysis will be used to grade the patient's skin by measuring the wrinkles and generating a percentile score.
Measured: Day 0, Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioral 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Maas Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Corey S. Maas, M.D., The Maas Clinic
- Investigators
- Corey S. Maas, M.D., Principal investigator, The Maas Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02818556
- Sponsor's protocol ID
- RSB-2015
- Status last verified
- Jun 2016
- First submitted
- 3 Jun 2016
- Last updated
- 29 Jun 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study Comparing Restylane® Silk and Belotero Balance® for the Treatment of Superficial, Vertical Perioral Lines
- ClinicalTrials.gov ID
- NCT02818556
- Acronym / sponsor ID
- RSB-2015
- Conditions
- Perioral Rhytids
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The Maas ClinicUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jan 2017 (estimated)
- First posted
- 29 Jun 2016 (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 will be a single-center, randomized, evaluator-blinded, split-face clinical study design. Fifty patients will receive one treatment session consisting of Restylane® Silk (right side of the face) and Belotero Balance® (left side), or vice versa (1:1 dose conversion ratio) injections to the superficial, vertical perioral lines. Injections will be performed at the baseline visit. To ensure subject and investigator blinding, syringes will be prepared and labeled "1" and "2" immediately before subject attendance for injection by the sub-investigator. The same injection sites and techniques will be used on both sides of the face. Then, patients will follow-up on post-treatment day 7, 14, 30, 60, 90, 120, 150, 180.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Restylane Right, Belotero Left | Other | Drug: Restalyne Silk, Drug: Belotero BalancePatients will receive one treatment with Restylane® Silk (right side of the face) and one treatment of Belotero Balance® (left side) |
| Restylane Left, Belotero Right | Other | Drug: Restalyne Silk, Drug: Belotero BalancePatients will receive one treatment with Restylane® Silk (left side of the face) and one treatment of Belotero Balance® (right side) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients exhibiting moderate [2] to severe [3] superficial, vertical perioral lines on the 5-point Merz® validated scale for assessment of superficial perioral lines
- Females and males in good general health over the age of 18 years old
- Must be willing to give and sign a HIPAA form, informed consent form and a photographic release form
- Patient is planning to undergo Restylane® Silk and Belotero Balance® injections
- For female patient of childbearing potential, must have had a regular menstrual cycle prior to study entry (a female is considered of childbearing potential unless she is postmenopausal, without a uterus and/or both ovaries, or has had a bilateral tubal ligation) and is willing to use an acceptable form of birth control during the entire course of the study [i.e., acceptable methods of birth control are oral contraceptives, contraceptive patches/rings/implants Norplanit®, Depo-Provena®, double-barrier methods (e.g. condoms and spermicide), abstinence and vasectomies of partner with a documented second acceptable method of birth control should the patient become sexually active]. All systemic birth control measures must be in consistent use at least 30 days prior to study participation
Key exclusion criteria (17 listed)
- A patient with any uncontrolled systemic disease. A potential patient in whom therapy for a systemic disease is not yet stabilized will not be considered for entry into the study
- A patient with a significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study.
- A patient with a known hypersensitivity to any of the components of the study medications
- A patient who is actively smoking or plans to smoke at any time of the duration of this study
- A patient with an active skin condition/disease that might interfere with the diagnosis or evaluation of study parameters (i.e., atopic dermatitis, eczema, psoriasis, seborrheic dermatitis, herpes labialis)
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 |
|---|---|---|
| Restalyne Silk | Drug | Restylane Left, Belotero Right, Restylane Right, Belotero Left |
| Belotero Balance | Drug | Restylane Left, Belotero Right, Restylane Right, Belotero Left |
Primary outcome
Change in Response to therapy as evaluated by investigator using 5-point Merz® Scale
Time frame: Day 0, 7, 14, 30, 60, 90, 120, 150, 180
Response to therapy on each side of the lip on day 0 (initial treatment), and subsequent post-treatment days 7, 14, 30, 60, 90, 120, 150, 180, as measured by the blinded evaluator: A 1-point improvement from baseline in superficial, vertical, perioral rhytids based on the 5-point Merz® Scale
3 secondary outcomes
Response to Therapy- Subject
Time frame: Day 0, 7, 14, 30, 60, 90, 120, 150, 180
Severity grading- Evaluator
Time frame: 6 months
VISIA complexion analysis
Time frame: Day 0, Day 30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2016.
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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.
Corey S. Maas, M.D. principal investigator
The Maas Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Restalyne Silk and Belotero Balance in people with Perioral Rhytids, run by The Maas Clinic 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 7 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 29 Jun 2016. 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rachel Bass ((415)567-8275, research@maasclinic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Response to therapy as evaluated by investigator using 5-point Merz® Scale (time frame: Day 0, 7, 14, 30, 60, 90, 120, 150, 180). 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 29 Jun 2016.