Lip AugmentationNCT01197495
Safety and Effectiveness of Juvederm(R) Ultra XC Injectable Gel for Lip Augmentation
A study testing hyaluronic acid gel in people with Lip Augmentation, run by Allergan at 1 site in United States.
Trial summary
The purpose of this study is to demonstrate the safety and effectiveness of Juvederm(R) Ultra XC Injectable Gel for lip augmentation Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lip Augmentation
- What is being tested?
- hyaluronic acid gel
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 213 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2010to 15 Jun 2015
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, 18 years of age or older
- Desire augmentation of his/her lips
- Have a pre-treatment score of Minimal or Mild
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 lips and perioral area, as judged by the Treating Investigator
- 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 ever undergone facial plastic surgery or received semi-permanent fillers or permanent facial implants (e.g., calcium hydroxylapatite, L-polylactic acid, PMMA, silicone, ePTFE) anywhere in the face or neck, or be planning to be implanted with any of these products at any time during the study
- Have undergone temporary dermal filler treatment within 24 months prior to study entry or be planning to undergo any of these procedures at any time during the study
- Have undergone cosmetic facial procedures, e.g., resurfacing (laser photomodulation, intense pulsed light, radio frequency, dermabrasion, chemical peel, or other ablative or non-ablative procedures) or mesotherapy anywhere in the face or neck, or BOTOX® Cosmetic injections in the lower face (below the orbital rim), within 6 months prior to entry in the study or be planning to undergo any of these procedures at any time during the study
Show all 14Show fewer
- Begin use of any new over-the-counter or prescription, oral or topical, anti-wrinkle products for the lips or around the mouth within 3 months (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 hydroxy acids, glycolic acids, retinol, or retinoic acids) is allowed if the regimen was established ≥ 3months (90 days) prior to enrollment and the regimen remains unchanged during the study
- Have a history of anaphylaxis, multiple severe allergies, atopy, allergy to lidocaine, hyaluronic acid products or Streptococcal protein, or be planning to undergo desensitization therapy during the term of the study
- Have an active inflammation, infection, cancerous or pre-cancerous lesion, or unhealed wound in the mouth area
- Be on an ongoing regimen of anti-coagulation therapy (e.g., warfarin) or have taken NSAIDS (e.g., aspirin, ibuprofen) or other substances known to increase coagulation time (e.g., herbal supplements with garlic or gingko) within 10 days of undergoing study device injections [Study device injections may be delayed as necessary to accommodate this 10-day washout period.]
- Be pregnant, lactating, or planning to become pregnant at any time during the study
- Have received investigational product within 30 days prior to study enrollment or be planning to participate in another investigation during the course of this study
- Be an employee (or immediate relative of an employee) of the Treating Investigator, Evaluating Investigator, Sponsor or representative of the Sponsor
- Have a condition or be in a situation that, in the Investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to demonstrate the safety and effectiveness of Juvederm(R) Ultra XC Injectable Gel for lip augmentation
Read the detailed description
All subjects were randomized to either the treatment group, Juvederm(R) Ultra XC Injectable Gel, or to the control group (no treatment). At month 3, subjects in the control group crossed over to the treatment group.
- Conditions
- Lip Augmentation
- Being tested
- hyaluronic acid gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hyaluronic acid gelDevice
Also called Juvederm(R) Ultra XC Injectable Gel
Dosage per Investigator's discretion to obtain lip treatment gel; 1 touch-up treatment is allowed 14 to 30 days after initial treatment. Repeat treatment occurs at month 12. Subjects in the control group start with treatment at month 3. Maximum total volume per subject is 4.8 mL for initial and touch-up treatment combined.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Juvederm(R) Ultra XC Injectable Gel Receives: Device: hyaluronic acid gel |
| Control | Experimental | No treatment for 3 months followed by Juvederm(R) Ultra XC Injectable Gel at Month 3. Receives: Device: hyaluronic acid gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects With ≥1-Point Improvement on the Investigator Assessed 5-point Lip Fullness Scale 2 (LFS2)
Overall lip fullness is assessed by the blinded Evaluating Investigator compared to baseline using the 5-point LFS2. Scores range from 1=minimal improvement to 5=very marked improvement.
Measured: Baseline, Month 3
Secondary outcomes (4)
Percentage of Subjects With ≥1-Point Improvement on the Perioral Line (POL) Severity Scale
Subject's upper lip perioral lines are assessed compared to baseline using the 4-point validated POL Severity Scale. Scores range from 0=None (best) to 3=Severe (worst).
Measured: Baseline, Month 3
Percentage of Oral Commissures With ≥1-Point Improvement on the Oral Commissures Severity (OCS) Scale
Subject's right and left oral commissures are assessed compared to baseline using the validated OCS Scale. Scores range from 0=none (best) to 3=severe (worst).
Measured: Baseline, Month 3
Percentage of Subjects Achieving Their Personal Treatment Goal of Overall Lip Fullness
Subjects assessed their personal treatment goal of overall lip fullness as 'achieved' or 'not achieved.'
Measured: Baseline, Month 3
Duration Effect of Treatment on Lip Fullness
Duration of treatment effect on lip fullness is assessed by the blinded Evaluating Investigator as ≥1-point Improvement from baseline in overall lip fullness of the eligible lip at each visit.
Measured: Month 1, Month 3, Month 6, Month 7.5, Month 9, Month 10.5, Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2010 (estimated)
- Study start1 Aug 2010
- Primary completion19 Jun 2014
- Study completion15 Jun 2015
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 Lip AugmentationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01197495
- Sponsor's protocol ID
- JULIDO-002
- Status last verified
- Apr 2019
- First submitted
- 8 Sep 2010
- Last updated
- 16 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Dayan S, Bruce S, Kilmer S, Dover JS, Downie JB, Taylor SC, Skorupa A, Murphy DK. Safety and Effectiveness of the Hyaluronic Acid Filler, HYC-24L, for Lip and Perioral Augmentation. Dermatol Surg. 2015 Dec;41 Suppl 1:S293-301. doi: 10.1097/DSS.0000000000000540.
PubMed 26618456
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
- Safety and Effectiveness of Juvederm(R) Ultra XC Injectable Gel for Lip Augmentation
- ClinicalTrials.gov ID
- NCT01197495
- Acronym / sponsor ID
- JULIDO-002
- Conditions
- Lip Augmentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2010 (actual)
- Primary completion
- 19 Jun 2014 (actual)
- Study completion
- 15 Jun 2015 (actual)
- First posted
- 9 Sep 2010 (estimated)
- Results
- Posted 7 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to demonstrate the safety and effectiveness of Juvederm(R) Ultra XC Injectable Gel for lip augmentation
Detailed description
All subjects were randomized to either the treatment group, Juvederm(R) Ultra XC Injectable Gel, or to the control group (no treatment). At month 3, subjects in the control group crossed over to the treatment group.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: hyaluronic acid gelJuvederm(R) Ultra XC Injectable Gel |
| Control | Experimental | Device: hyaluronic acid gelNo treatment for 3 months followed by Juvederm(R) Ultra XC Injectable Gel at Month 3. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female, 18 years of age or older
- Desire augmentation of his/her lips
- Have a pre-treatment score of Minimal or Mild
Key exclusion criteria (14 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 lips and perioral area, as judged by the Treating Investigator
- 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 ever undergone facial plastic surgery or received semi-permanent fillers or permanent facial implants (e.g., calcium hydroxylapatite, L-polylactic acid, PMMA, silicone, ePTFE) anywhere in the face or neck, or be planning to be implanted with any of these products at any time during the study
- Have undergone temporary dermal filler treatment within 24 months prior to study entry or be planning to undergo any of these procedures at any time during the study
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 |
|---|---|---|
| hyaluronic acid gelAlso: Juvederm(R) Ultra XC Injectable GelDosage per Investigator's discretion to obtain lip treatment gel; 1 touch-up treatment is allowed 14 to 30 days after initial treatment. Repeat treatment occurs at month 12. Subjects in the control group start with treatment at month 3. Maximum total volume per subject is 4.8 mL for initial and touch-up treatment combined. | Device | Control, Treatment |
Primary outcome
Percentage of Subjects With ≥1-Point Improvement on the Investigator Assessed 5-point Lip Fullness Scale 2 (LFS2)
Time frame: Baseline, Month 3
Overall lip fullness is assessed by the blinded Evaluating Investigator compared to baseline using the 5-point LFS2. Scores range from 1=minimal improvement to 5=very marked improvement.
4 secondary outcomes
Percentage of Subjects With ≥1-Point Improvement on the Perioral Line (POL) Severity Scale
Time frame: Baseline, Month 3
Percentage of Oral Commissures With ≥1-Point Improvement on the Oral Commissures Severity (OCS) Scale
Time frame: Baseline, Month 3
Percentage of Subjects Achieving Their Personal Treatment Goal of Overall Lip Fullness
Time frame: Baseline, Month 3
Duration Effect of Treatment on Lip Fullness
Time frame: Month 1, Month 3, Month 6, Month 7.5, Month 9, Month 10.5, Month 12
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 26618456Dayan S, Bruce S, Kilmer S, Dover JS, Downie JB, Taylor SC, Skorupa A, Murphy DK. Safety and Effectiveness of the Hyaluronic Acid Filler, HYC-24L, for Lip and Perioral Augmentation. Dermatol Surg. 2015 Dec;41 Suppl 1:S293-301. doi: 10.1097/DSS.0000000000000540.
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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 hyaluronic acid gel in people with Lip Augmentation, 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 3 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 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 7 Jun 2016). 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 Subjects With ≥1-Point Improvement on the Investigator Assessed 5-point Lip Fullness Scale 2 (LFS2) (time frame: Baseline, Month 3). 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 NCT01197495, 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.