Patients With Moderate to Severe Perioral LinesNCT01970397
JUVEDERM® Ultra XC vs. Belotero Balance® for Perioral Lines
A study testing JUVEDERM® Ultra XC and Belotero Balance® in people with Patients With Moderate to Severe Perioral Lines, run by Allergan at 1 site in United States.
Trial summary
A prospective, randomized, controlled, multi-center study of the safety and effectiveness of JUVEDERM® Ultra XC injectable gel versus Belotero Balance® for perioral lines Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Patients With Moderate to Severe Perioral Lines
- What is being tested?
- JUVEDERM® Ultra XC and Belotero Balance®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Oct 2013to 4 Aug 2014
- Phase
- Interventional
- 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have moderate to severe perioral lines as assessed by the Investigator using the 4-point POLSS (none, mild, moderate, and severe)
- Accept the obligation not to receive any other facial procedures or treatments at any time during the study that are not study related
Who cannot join
- Have lip tattoos, facial hair or scars that would interfere with visualization of the lips and perioral area for the effectiveness assessments
- Have dentures or any device covering all or part of the upper palate, and/or severe malocclusion, dentofacial or maxillofacial deformities, or significant asymmetry of the perioral area, as judged by the Treating Investigator
- Have a history of skin cancer
- Is an active smoker
- Has noticeable acne scarring, active inflammation, infection, cancerous or precancerous lesion, or unhealed wound in the mouth area
- Have had an active oral herpes or cold sore within 12 months
Show all 13Show fewer
- Have undergone oral surgery or other dental procedures (e.g., tooth extraction, orthodontia, or implantation) within 30 days prior to enrollment or be planning to undergo any of these procedures during the study
- Have undergone cosmetic facial or perioral area procedures [e.g., face-lift, or other surgeries which may alter the appearance of the perioral area, including tissue grafting, or tissue augmentation with silicone, fat, or other permanent fillers] or be planning to undergo any of these procedures at any time during the study
- Have undergone temporary or semi-permanent facial dermal filler injections (e.g., hyaluronic acid, calcium hydroxylapatite, L-Polylactic acid) in the lower face (below the orbital rim) within 24 months
- Have received mesotherapy, or resurfacing (laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, chemical peel, or other ablative or non-ablative procedures) within 6 months prior to entry in the study or be planning to undergo any of these procedures at any time during the study other than study related procedures.
- Have begun use of any new over-the-counter or prescription, oral or topical, antiwrinkle products in the treatment area within 90 days prior to enrollment or be planning to begin use of such products at any time during the study. [NOTE: Use of sunscreens and continued therapy with some cosmeceuticals (e.g., alpha hydroxyl acids, glycolic acids, retinol, or retinoic acids) is allowed if the regimen was established ≥ 90 days prior to enrollment]
- Have had epilation (e.g. laser hair removal, electrolysis, threading, etc.) in the perioral area performed within 3 months
- Have received treatment with botulinum toxin of any serotype for any indication in the lower face [below the infraorbital rims (IORs)] within 1 year of the baseline visit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized, Controlled, Multi-center Study of the Safety and Effectiveness of JUVEDERM® Ultra XC Injectable Gel Versus Belotero Balance® for Perioral Lines
A prospective, randomized, controlled, multi-center study of the safety and effectiveness of JUVEDERM® Ultra XC injectable gel versus Belotero Balance® for perioral lines
- Being tested
- JUVEDERM® Ultra XC, Belotero Balance®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JUVEDERM® Ultra XCDevice
Up to 3.0 mLs JUVEDERM® Ultra XC injected into the mid to deep dermis (2.0 mLs for initial treatment and 1.0 mL for touch-up treatment).
Belotero Balance®Device
Up to 3.0 mLs Belotero Balance® injected into the mid to deep dermis (2.0 mLs for initial treatment and 1.0 mL for touch-up treatment).
| Study group | Role | What they receive |
|---|---|---|
| JUVEDERM® Ultra XC | Experimental | Perioral lines treated with JUVEDERM® Ultra XC Receives: Device: JUVEDERM® Ultra XC |
| Belotero Balance® | Experimental | Perioral Lines treated with Belotero Balance® Receives: Device: Belotero Balance® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With at Least a 1 Point Improvement From Baseline on the Perioral Lines Severity Scale (POLSS)
The investigator evaluated the severity of the participant's upper and low lip at Baseline (Pre-treatment) to Month 6 using the 4-point POLSS where None=No lines, Mild=Few, shallow lines, Moderate=Some, moderate lines or Severe=Many, deep lines or crevices. The percentage of participants with at least a 1 Point Improvement is reported.
Measured: Baseline, Month 6
Secondary outcomes (2)
Participant Assessed Procedural and Post-Procedural Pain Levels
The participant assessed procedural and post-procedural pain using an 11-point scale where: 0=no pain to 10=worst pain imaginable.
Measured: During injection, immediately following injection, 15, 30, and 45 min post-injection
Subject's Global Assessment of Change in Appearance of Perioral Lines
The participant evaluated the change in the appearance of their perioral lines (the lines that radiate outward from the edges of the upper and lower lips) using a 7-point scale where: 1 = Very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; 7=Very much worse.
Measured: Baseline, Days 7, 14, Days 7, 14 after touch-up, Months 1, 3 and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2013 (estimated)
- Study start21 Oct 2013
- Primary completion4 Aug 2014
- Study completion4 Aug 2014
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patients With Moderate to Severe Perioral LinesStudies 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, Outcomes assessor
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01970397
- Sponsor's protocol ID
- GMA-JUV13001
- Status last verified
- Apr 2019
- First submitted
- 23 Oct 2013
- Last updated
- 16 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Butterwick K, Marmur E, Narurkar V, Cox SE, Joseph JH, Sadick NS, Tedaldi R, Wheeler S, Kolodziejczyk JK, Gallagher CJ. HYC-24L Demonstrates Greater Effectiveness With Less Pain Than CPM-22.5 for Treatment of Perioral Lines in a Randomized Controlled Trial. Dermatol Surg. 2015 Dec;41(12):1351-60. doi: 10.1097/DSS.0000000000000576.
PubMed 26606435
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled, Multi-center Study of the Safety and Effectiveness of JUVEDERM® Ultra XC Injectable Gel Versus Belotero Balance® for Perioral Lines
- ClinicalTrials.gov ID
- NCT01970397
- Acronym / sponsor ID
- GMA-JUV13001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 21 Oct 2013 (actual)
- Primary completion
- 4 Aug 2014 (actual)
- Study completion
- 4 Aug 2014 (actual)
- First posted
- 28 Oct 2013 (estimated)
- Results
- Posted 2 Sep 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, randomized, controlled, multi-center study of the safety and effectiveness of JUVEDERM® Ultra XC injectable gel versus Belotero Balance® for perioral lines
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JUVEDERM® Ultra XC | Experimental | Device: JUVEDERM® Ultra XCPerioral lines treated with JUVEDERM® Ultra XC |
| Belotero Balance® | Experimental | Device: Belotero Balance®Perioral Lines treated with Belotero Balance® |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Have moderate to severe perioral lines as assessed by the Investigator using the 4-point POLSS (none, mild, moderate, and severe)
- Accept the obligation not to receive any other facial procedures or treatments at any time during the study that are not study related
Key exclusion criteria (13 listed)
- Have lip tattoos, facial hair or scars that would interfere with visualization of the lips and perioral area for the effectiveness assessments
- Have dentures or any device covering all or part of the upper palate, and/or severe malocclusion, dentofacial or maxillofacial deformities, or significant asymmetry of the perioral area, as judged by the Treating Investigator
- Have a history of skin cancer
- Is an active smoker
- Has noticeable acne scarring, active inflammation, infection, cancerous or precancerous lesion, or unhealed wound in the mouth 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 |
|---|---|---|
| JUVEDERM® Ultra XCUp to 3.0 mLs JUVEDERM® Ultra XC injected into the mid to deep dermis (2.0 mLs for initial treatment and 1.0 mL for touch-up treatment). | Device | JUVEDERM® Ultra XC |
| Belotero Balance®Up to 3.0 mLs Belotero Balance® injected into the mid to deep dermis (2.0 mLs for initial treatment and 1.0 mL for touch-up treatment). | Device | Belotero Balance® |
Primary outcome
Percentage of Participants With at Least a 1 Point Improvement From Baseline on the Perioral Lines Severity Scale (POLSS)
Time frame: Baseline, Month 6
The investigator evaluated the severity of the participant's upper and low lip at Baseline (Pre-treatment) to Month 6 using the 4-point POLSS where None=No lines, Mild=Few, shallow lines, Moderate=Some, moderate lines or Severe=Many, deep lines or crevices. The percentage of participants with at least a 1 Point Improvement is reported.
2 secondary outcomes
Participant Assessed Procedural and Post-Procedural Pain Levels
Time frame: During injection, immediately following injection, 15, 30, and 45 min post-injection
Subject's Global Assessment of Change in Appearance of Perioral Lines
Time frame: Baseline, Days 7, 14, Days 7, 14 after touch-up, Months 1, 3 and 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26606435Butterwick K, Marmur E, Narurkar V, Cox SE, Joseph JH, Sadick NS, Tedaldi R, Wheeler S, Kolodziejczyk JK, Gallagher CJ. HYC-24L Demonstrates Greater Effectiveness With Less Pain Than CPM-22.5 for Treatment of Perioral Lines in a Randomized Controlled Trial. Dermatol Surg. 2015 Dec;41(12):1351-60. doi: 10.1097/DSS.0000000000000576.
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.
Medical Director study director
Allergan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing JUVEDERM® Ultra XC and Belotero Balance® in people with Patients With Moderate to Severe Perioral Lines, run by Allergan 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 13 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 16 Apr 2019. 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?
Yes. Results are posted in the registry (first posted 2 Sep 2015). 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?
Percentage of Participants With at Least a 1 Point Improvement From Baseline on the Perioral Lines Severity Scale (POLSS) (time frame: Baseline, Month 6). 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 NCT01970397, 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 16 Apr 2019.