Glabellar LinesPhase 4NCT02718118
Comparison of Dysport Reconstitution at 1.5 mL and 2.5 mL for the Treatment of Moderate to Severe Glabellar Lines
A Phase 4 study testing Dysport reconstituted at 1.5 mL (0.05 mL/injection) and Dysport reconstituted at 2.5 mL (0.08 mL/injection) in people with Glabellar Lines and Wrinkles, run by Galderma R&D at 3 sites in United States.
Trial summary
This study is designed to evaluate the safety, efficacy, and subject and investigator satisfaction of 2 different injection volumes of Dysport in the glabellar lines. 1. To determine the proportion of composite responders (based on blinded evaluator and subject assessments) who achieve at least a 1-point reduction… Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Glabellar Lines, Wrinkles
- What is being tested?
- Dysport reconstituted at 1.5 mL (0.05 mL/injection) and Dysport reconstituted at 2.5 mL (0.08 mL/injection)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2016to Oct 2016
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Botulinum toxin naïve subject (facial area)
- Moderate to severe (GLSS = 2 or 3) glabellar lines at maximum frown and mild to severe (GLSS = 1, 2, or 3) glabellar lines at rest using the validated 4-point Photographic Scale, as assessed by the treating investigator and the blinded evaluator.
Who cannot join
- Have known allergies or sensitivities to Dysport®, any of its excipients, or cow's milk protein
- Have rhytids of the glabellar region that cannot be smoothed out by manually spreading the skin apart
- Have a history or have signs and symptoms of eyelid or brow ptosis or signs of compensatory frontalis muscle activity, as judged by the investigator
- Have clinical or subclinical neuromuscular junctional disorders (eg, myasthenia gravis, Lambert Eaton syndrome, or amyotrophic lateral sclerosis) or a history of dysphagia or aspiration
- Are women who are pregnant or breast-feeding or who intend to get pregnant within the duration of the study
- Have an active inflammation or infection in the areas to be treated or had any prior surgery, tattoos, piercings, or scarring in the facial area that, in the opinion of the investigator, may interfere with the results
- Have had any previous insertion of any permanent or semi-permanent material, hyaluronic acid, or collagen fillers in the glabellar region
- Have any chronic or acute medical condition that, may pose a risk to the safety of the subject, or may interfere with the assessment of safety or efficacy in this study
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Skin Research Institute
Coral Gables, Florida
AboutSkin Dermatology and DermSurgery
Greenwood Village, Colorado
Marina Peredo, MD, PC
Smithtown, New York
About this study
Official title: A Prospective, Randomized, Multi-Center, Subject- and Evaluator-Blinded, Parallel Comparison of Dysport®, When Reconstituted at 1.5 mL and 2.5 mL, for the Treatment of Moderate to Severe Glabellar Lines.
This study is designed to evaluate the safety, efficacy, and subject and investigator satisfaction of 2 different injection volumes of Dysport in the glabellar lines.
- To determine the proportion of composite responders (based on blinded evaluator and subject assessments) who achieve at least a 1-point reduction from baseline in glabellar line severity score (GLSS) at maximum frown line on Day 30.
- To assess the GLSS, at maximum frown and at rest, by live assessment at all visits.
- To evaluate the onset of effect on appearance of glabellar lines starting at the Day 2 visit (subject and blinded evaluator).
- To assess the subject's satisfaction with the treatment.
- To evaluate investigator satisfaction of treatment outcome.
- To evaluate subject psychological well-being.
- To evaluate subject age appraisal.
- To evaluate all adverse events during the course of the study.
Read the detailed description
Five month, randomized, subject- and evaluator-blinded, multi-center, mult-visit study. Subjects treated with Dysport following the US on-label guidelines.
- Conditions
- Glabellar Lines, Wrinkles
- Being tested
- Dysport reconstituted at 1.5 mL (0.05 mL/injection), Dysport reconstituted at 2.5 mL (0.08 mL/injection)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dysport reconstituted at 1.5 mL (0.05 mL/injection)Device
Subjects treated for moderate to severe (GLSS = 2 or 3) glabellar lines at maximum frown.
Dysport reconstituted at 2.5 mL (0.08 mL/injection)Device
Subjects treated for moderate to severe (GLSS = 2 or 3) glabellar lines at maximum frown.
| Study group | Role | What they receive |
|---|---|---|
| 1.5 mL Reconstitution | Experimental | Subjects treated with Dysport reconstituted at 1.5 mL (0.05 mL/injection) following the US on-label guidelines, with each subject receiving a single treatment session (50 units [U]) at the Day 1 visit. Receives: Device: Dysport reconstituted at 1.5 mL (0.05 mL/injection) |
| 2.5 mL Reconstitution | Experimental | Subjects treated with Dysport reconstituted at 2.5 mL (0.08 mL/injection) following the US on-label guidelines, with each subject receiving a single treatment session (50 units [U]) at the Day 1 visit. Receives: Device: Dysport reconstituted at 2.5 mL (0.08 mL/injection) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Composite Responders Who Achieve at Least a 1-point Reduction From Baseline in Glabellar Line Severity Score (GLSS) at Maximum Frown.
Proportion of composite responders who achieve at least a 1-point reduction from baseline in glabellar line severity score (GLSS) based on subject and blinded-evaluator assessment of glabellar line severity at maximum frown on Day 30.
Measured: 30 days
Secondary outcomes (14)
Proportion of Responders, at Maximum Frown (Subject)
Proportion of responders, at maximum frown, with GLSS at least 1-point reduction from baseline on days 2, 3, 4, 7, 14, 30, 90 and 120 based on assessments by subject using a static 4-point categorical (subject) scale.
Measured: 120 days
Proportion of Responders, at Maximum Frown (Blinded Evaluator)
Proportion of responders, at maximum frown, with GLSS at least 1-point reduction from baseline on days 2, 3, 4, 7, 14, 30, 90 and 120 based on assessments by blinded evaluator using a validated 4-point photographic scale.
Measured: 120 days
Proportion of Responders, at Maximum Frown (Treating Investigator)
Proportion of responders, at maximum frown, with GLSS at least 1-point reduction from baseline on days 2, 3, 4, 7, 14, 30, 90 and 120 based on assessments by treating investigator using a validated 4-point photographic scale.
Measured: 120 days
Proportion of Combination Responders, at Maximum Frown (Blinded Evaluator and Subject)
Proportion of combination responders, at maximum frown, with GLSS at least 1-point reduction from baseline on days 2, 3, 4, 7, 14, 30, 90 and 120 based on assessments made by blinded evaluator and subject.
Measured: 120 days
Proportion of Responders, at Rest (Subject)
Proportion of responders, at rest, with GLSS at least 1-point reduction from baseline on days 2, 3, 4, 7, 14, 30, 90 and 120 based on assessments made by subject using a static 4-point categorical (subject) scale.
Measured: 120 days
Proportion of Responders, at Rest (Blinded Evaluator)
Proportion of responders, at rest, with GLSS at least 1-point reduction from baseline on days 2, 3, 4, 7, 14, 30, 90 and 120 based on assessments made by blinded evaluator using a validated 4-point photographic scale.
Measured: 120 days
Proportion of Responders, at Rest (Treating Investigator)
Proportion of combination responders, at rest, with GLSS at least 1-point reduction from baseline on days 2, 3, 4, 7, 14, 30, 90 and 120 based on assessments made by treating investigator using a validated 4-point photographic scale.
Measured: 120 days
Proportion of Combination Responders, at Rest (Blinded Evaluator and Subject)
Proportion of combination responders, at rest, with GLSS at least 1-point reduction from baseline on days 2, 3, 4, 7, 14, 30, 90 and 120 based on assessments made by blinded evaluator and subject.
Measured: 120 days
Proportion of Subjects Who Achieved an Onset of Effect on the Appearance of the Subject's Glabellar Lines.
Combination endpoint from both subject and blinded evaluator assessments. Assessments made on days 2, 3, 4, and 7.
Measured: 7 days
Subject Satisfaction With the Treatment of Glabellar Lines - I am Satisfied With How I Look.
Proportion of subjects who responded 'agree' or 'strongly agree' regarding change from baseline in subject satisfaction questionnaire on day 120.
Measured: 120 days
Investigator Satisfaction With Treatment Outcome - Satisfied With the Study Product Results
Proportion of treating investigators who responded 'agree' or 'strongly agree' to the individual satisfaction questions on Day 30.
Measured: 30 days
Subject Psychological Well-being - Mean Change at Day 120 Compared to Baseline
Mean change from baseline on day 120 using the Psychological Well-Being (FACE-Q).Total score for entire questionnaire is transformed to a Rasch score, scale of 0-100.
Increase in score = increased well-being.
Measured: Baseline and Day 120
Subject Age Appraisal Using the FACE-Q-Age Appraisal Visual Analog Scale (VAS) - Mean Change at Day 120 Compared to Baseline
Mean change from baseline on day 120 using the FACE-Q Age Appraisal VAS. "0" years represents "current age subjects rated their appearance as older or younger than current age"; "+" years represents "older than current age"; "-" years represents "younger than current age".
Measured: Baseline and Day 120
Subject Appraisal of Lines Between the Eyebrows (FACE-Q) - Mean Change at Day 120 Compared to Baseline
Mean change from baseline on day 120 using the Subject Appraisal Lines Between the Eyebrows (FACE-Q).Total score for entire questionnaire is transformed to a Rasch score, scale of 0-100. Increase in score = less bothered by glabellar lines.
Measured: Baseline and Day 120
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2016 (estimated)
- Study startApr 2016
- Primary completionOct 2016
- Study completionOct 2016
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 Glabellar LinesStudies of the same condition, open and under way.
- More trials run by Galderma R&DThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jay Mashburn, PhD, Study director, Galderma Laboratories, LP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02718118
- Sponsor's protocol ID
- GLI.04.SPR.US10348
- Status last verified
- Sep 2018
- First submitted
- 16 Mar 2016
- Last updated
- 1 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Multi-Center, Subject- and Evaluator-Blinded, Parallel Comparison of Dysport®, When Reconstituted at 1.5 mL and 2.5 mL, for the Treatment of Moderate to Severe Glabellar Lines.
- ClinicalTrials.gov ID
- NCT02718118
- Acronym / sponsor ID
- GLI.04.SPR.US10348
- Conditions
- Glabellar Lines, Wrinkles
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 24 Mar 2016 (estimated)
- Results
- Posted 25 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to evaluate the safety, efficacy, and subject and investigator satisfaction of 2 different injection volumes of Dysport in the glabellar lines.
- To determine the proportion of composite responders (based on blinded evaluator and subject assessments) who achieve at least a 1-point reduction from baseline in glabellar line severity score (GLSS) at maximum frown line on Day 30.
- To assess the GLSS, at maximum frown and at rest, by live assessment at all visits.
- To evaluate the onset of effect on appearance of glabellar lines starting at the Day 2 visit (subject and blinded evaluator).
- To assess the subject's satisfaction with the treatment.
- To evaluate investigator satisfaction of treatment outcome.
- To evaluate subject psychological well-being.
- To evaluate subject age appraisal.
- To evaluate all adverse events during the course of the study.
Detailed description
Five month, randomized, subject- and evaluator-blinded, multi-center, mult-visit study. Subjects treated with Dysport following the US on-label guidelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1.5 mL Reconstitution | Experimental | Device: Dysport reconstituted at 1.5 mL (0.05 mL/injection)Subjects treated with Dysport reconstituted at 1.5 mL (0.05 mL/injection) following the US on-label guidelines, with each subject receiving a single treatment session (50 units [U]) at the Day 1 visit. |
| 2.5 mL Reconstitution | Experimental | Device: Dysport reconstituted at 2.5 mL (0.08 mL/injection)Subjects treated with Dysport reconstituted at 2.5 mL (0.08 mL/injection) following the US on-label guidelines, with each subject receiving a single treatment session (50 units [U]) at the Day 1 visit. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Botulinum toxin naïve subject (facial area)
- Moderate to severe (GLSS = 2 or 3) glabellar lines at maximum frown and mild to severe (GLSS = 1, 2, or 3) glabellar lines at rest using the validated 4-point Photographic Scale, as assessed by the treating investigator and the blinded evaluator.
Key exclusion criteria (8 listed)
- Have known allergies or sensitivities to Dysport®, any of its excipients, or cow's milk protein
- Have rhytids of the glabellar region that cannot be smoothed out by manually spreading the skin apart
- Have a history or have signs and symptoms of eyelid or brow ptosis or signs of compensatory frontalis muscle activity, as judged by the investigator
- Have clinical or subclinical neuromuscular junctional disorders (eg, myasthenia gravis, Lambert Eaton syndrome, or amyotrophic lateral sclerosis) or a history of dysphagia or aspiration
- Are women who are pregnant or breast-feeding or who intend to get pregnant within the duration of 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 |
|---|---|---|
| Dysport reconstituted at 1.5 mL (0.05 mL/injection)Subjects treated for moderate to severe (GLSS = 2 or 3) glabellar lines at maximum frown. | Device | 1.5 mL Reconstitution |
| Dysport reconstituted at 2.5 mL (0.08 mL/injection)Subjects treated for moderate to severe (GLSS = 2 or 3) glabellar lines at maximum frown. | Device | 2.5 mL Reconstitution |
Primary outcome
Proportion of Composite Responders Who Achieve at Least a 1-point Reduction From Baseline in Glabellar Line Severity Score (GLSS) at Maximum Frown.
Time frame: 30 days
Proportion of composite responders who achieve at least a 1-point reduction from baseline in glabellar line severity score (GLSS) based on subject and blinded-evaluator assessment of glabellar line severity at maximum frown on Day 30.
14 secondary outcomes
Proportion of Responders, at Maximum Frown (Subject)
Time frame: 120 days
Proportion of Responders, at Maximum Frown (Blinded Evaluator)
Time frame: 120 days
Proportion of Responders, at Maximum Frown (Treating Investigator)
Time frame: 120 days
Proportion of Combination Responders, at Maximum Frown (Blinded Evaluator and Subject)
Time frame: 120 days
Proportion of Responders, at Rest (Subject)
Time frame: 120 days
Proportion of Responders, at Rest (Blinded Evaluator)
Time frame: 120 days
Proportion of Responders, at Rest (Treating Investigator)
Time frame: 120 days
Proportion of Combination Responders, at Rest (Blinded Evaluator and Subject)
Time frame: 120 days
Proportion of Subjects Who Achieved an Onset of Effect on the Appearance of the Subject's Glabellar Lines.
Time frame: 7 days
Subject Satisfaction With the Treatment of Glabellar Lines - I am Satisfied With How I Look.
Time frame: 120 days
Investigator Satisfaction With Treatment Outcome - Satisfied With the Study Product Results
Time frame: 30 days
Subject Psychological Well-being - Mean Change at Day 120 Compared to Baseline
Time frame: Baseline and Day 120
Subject Age Appraisal Using the FACE-Q-Age Appraisal Visual Analog Scale (VAS) - Mean Change at Day 120 Compared to Baseline
Time frame: Baseline and Day 120
Subject Appraisal of Lines Between the Eyebrows (FACE-Q) - Mean Change at Day 120 Compared to Baseline
Time frame: Baseline and Day 120
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Jay Mashburn, PhD study director
Galderma Laboratories, LP
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 Dysport reconstituted at 1.5 mL (0.05 mL/injection) and Dysport reconstituted at 2.5 mL (0.08 mL/injection) in people with Glabellar Lines and Wrinkles, run by Galderma R&D 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 2 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 1 Aug 2022. 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?
Yes. Results are posted in the registry (first posted 25 Sep 2018). 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?
Proportion of Composite Responders Who Achieve at Least a 1-point Reduction From Baseline in Glabellar Line Severity Score (GLSS) at Maximum Frown. (time frame: 30 days). 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 1 Aug 2022.