AestheticsPhase 4NCT02297516
Safety and Efficacy of Azzalure/Dysport, Restylane/Emervel Filler and Restylane Skinbooster Treatment
A Phase 4 study testing Azzalure or Dysport, Restylane or Emervel filler and Restylane Skinbooster in people with Aesthetics, run by Galderma R&D at 4 sites in 3 countries.
Trial summary
The efficacy and safety, as well as subject satisfaction will be evaluated after single treatment with Azzalure/Dysport alone or Restylane/Emervel filler alone followed by repeated combined treatment with Azzalure/Dysport, Restylane/Emervel filler and Restylane Skinbooster. Read more about this study
- Who is it for?
- Ages 35 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Aesthetics
- What is being tested?
- Azzalure or Dysport, Restylane or Emervel filler and Restylane Skinbooster
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Nov 2014to Mar 2017
- 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 35 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects aged 35 to 50 years old
- Subjects with the intention to undergo facial aesthetic treatment and who are likely to benefit from a combination of injection treatments and the benefit can be shown by improvements in their global facial aesthetic appearance and satisfaction.
- Subjects with nasolabial folds assessed as mild or moderate.
- Subjects with upper facial lines to be treated (at least two of glabellar lines, crow´s feet and/or forehead lines) assessed as moderate or severe, when the severity of the lines has an important psychological impact on the subject.
- Subjects with signed informed consent.
Who cannot join
- Obvious facial sagging (major loss of facial fat/volume).
- Signs or symptoms of eyelid ptosis or signs of compensatory frontalis muscle activity.
- Heavily scarred or sun-damaged facial skin.
- Active skin disease, inflammation or related conditions, such as infection, psoriasis and herpes zoster/herpes simplex near or on the areas to be treated.
- Cancerous or pre-cancerous lesions in the areas to be treated.
- Facial tissue augmenting therapy or revitalization treatment with hyaluronic acid (HA) or collagen, or botulinum toxin treatment during the last 12 months.
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- Procedures or treatments inducing an active dermal response such as laser, Intense Pulsed Light, chemical peeling, microdermabrasion, retinoids within the last 6 months.
- Any aesthetic surgery of the face.
- Permanent implant or aesthetic treatment with non-HA or non-collagen products in the face.
- History of severe keloids and/or hypertrophic scars.
- Neuromuscular junctional disorders (e.g. myasthenia gravis, Eaton Lambert syndrome or amyotrophic lateral sclerosis) or history of dysphagia and aspiration.
- Known hypersensitivity to hyaluronic acid, botulinum toxin, lidocaine hydrochloride or other amide-type anesthetics.
- History of autoimmune diseases.
- Any medical condition that in the opinion of the investigator would make the subject unsuitable for inclusion (e.g. a chronic, relapsing or hereditary disease that may affect the general condition or may require frequent medical treatment).
- Concomitant anticoagulant therapy and therapy with inhibitors of platelet aggregation (e.g. aspirin or other nonsteroidal anti-inflammatory drugs [NSAIDs]), Omega-3 or vitamin E within 10 days before study treatment, or a history of bleeding disorders.
- Immunosuppressive therapy, chemotherapy, or systemic corticosteroids within the last 3 months prior to baseline visit.
- Female subjects who are pregnant or plan to become pregnant within the study timeframe, or who are nursing.
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
France2 sites
Centre Medical Saint-Jean
Arras, 62000
Mediti Center
Paris, Antibes, 06160
Brazil1 site
Brazilian Center for Studies in Dermatology
Porto Alegre, 90570-040
About this study
Official title: An Evaluator-blinded Multi-center Study of Combined Treatment With Azzalure/Dysport, Restylane/Emervel Filler and Restylane Skinbooster as Compared to Single Treatment With Either Azzalure/Dysport Alone or Restylane/Emervel Filler Alone
The efficacy and safety, as well as subject satisfaction will be evaluated after single treatment with Azzalure/Dysport alone or Restylane/Emervel filler alone followed by repeated combined treatment with Azzalure/Dysport, Restylane/Emervel filler and Restylane Skinbooster. Subjects will be followed for up to 18 months after initial treatment.
- Conditions
- Aesthetics
- Being tested
- Azzalure or Dysport, Restylane or Emervel filler, Restylane Skinbooster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azzalure or DysportDrug
Also called Botulinum toxin
Glabellar lines
Restylane or Emervel fillerDevice
Also called Hyaluronic acid
Facial tissue augmentation
Restylane SkinboosterDevice
Also called Hyaluronic acid
Facial skin rejuvenation
| Study group | Role | What they receive |
|---|---|---|
| Azzalure/Dysport as single treatment | Experimental | Azzalure/Dysport as single treatment at initial treatment Receives: Drug: Azzalure or Dysport; Device: Restylane or Emervel filler; Device: Restylane Skinbooster |
| Filler as single treatment | Experimental | Filler as single treatment at initial treatment Receives: Drug: Azzalure or Dysport; Device: Restylane or Emervel filler; Device: Restylane Skinbooster |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects With Improvement in Global Facial Aesthetic Appearance
Percentage of subjects showing superior global facial aesthetic appearance at month 7 compared to month 1.
Assessment of global facial aesthetic appearance was based on blinded evaluations of subject's youthful appearance (e.g. lack of facial volume loss, lack of static wrinkles and fine lines, good skin quality, and satisfactory result after aesthetic treatment).
The blinded evaluators retrospectively reviewed photographs from visit for each subject and answered the following question: "At which set of photographs does the subject show superior global facial aesthetic appearance?".
Measured: 7 months
Secondary outcomes (6)
Percentage of Subjects With Improvement in Global Facial Aesthetic Appearance
Subjects showing superior "Global facial aesthetic appearance" at 1, 7 and 13 months.
Assessment of global facial aesthetic appearance was based on blinded evaluations of subject's youthful appearance (e.g. lack of facial volume loss, lack of static wrinkles and fine lines, good skin quality, and satisfactory result after aesthetic treatment).
The blinded evaluators retrospectively reviewed photographs from visit for each subject and answered the following question: "At which set of photographs does the subject show superior global facial aesthetic appearance?".
Measured: 1, 7 and 13 months
Number of Subjects Improved on the Global Aesthetic Improvement Scale (GAIS) as Assessed by Blinded Evaluator
The 5-graded GAIS was used to assess the facial aesthetic improvement from Baseline by responding to the question: "How would you describe the subject's global facial aesthetic appearance compared to the photographs taken before treatment at Baseline?".
The following rating was used: Very much improved, Much improved, Somewhat improved, No change, or Worse.
Criteria for improvement met for those subjects that were assessed as Very much improved, Much improved, or Somewhat improved.
GAIS score was assessed by three blinded evaluators at Months 1, 7, and 13 (1 month after single treatment, 1 month after first combined treatment, and 1 month after second combined treatment). The blinded evaluators performed the evaluations retrospectively using 2D-photographs from each follow-up visit and from Baseline (Visit 1).
Measured: 1, 7, and 13 months
Number of Participants Satisfied With Facial Appearance
The subjects were asked to answer the question "How satisfied are you today with the appearance of your face?" with "Very/somewhat satisfied", "Neither/nor", or "Very/somewhat dissatisfied". Satisfied criteria is fulfilled for those subjects that answered ""Very/somewhat satisfied".
Measured: 7 and 13 months
Number of Participants for Which the Investigator is Satisfied With the Outcome
The Investigators answered the question "How satisfied are you with the overall facial aesthetic outcome for the subject?" with "Very/somewhat satisfied", "Neither/nor", or "Very/somewhat dissatisfied". Satisfied criteria met for those subjects that the Investigator answered "Very/somewhat satisfied".
Measured: 7 and 13 months
Percentage of Subjects Improved in Wrinkle Severity Score
The wrinkle severity of the Azzalure/Dysport treated glabellar lines at maximum frown was evaluated by the Investigator.
A validated 5-graded photonumeric grading scale was used, where each severity grade was illustrated by a set of photographs.
0 = No glabella lines
- = Mild glabella lines
- = Moderate glabella lines
- = Severe glabella lines
- = Very severe glabella lines Improvement means going from higher score to lower score.
Measured: 7 and 13 months
Injected Volume of Study Products at Initial Single Treatment
Evaluation of Azzalure/Dysport (Group A)/Filler (Group B) volume injected at initial single treatment (baseline).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionMar 2017
- Study completionMar 2017
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 AestheticsStudies 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
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philippe Kestemont, MD, Principal investigator, Clinique Science et Beauté, Antibes, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02297516
- Sponsor's protocol ID
- 05PDF1401
- Status last verified
- Sep 2019
- First submitted
- 31 Oct 2014
- Last updated
- 14 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Heden P, Hexsel D, Cartier H, Bergentz P, Delmar H, Camozzato F, Siega C, Skoglund C, Edwartz C, Norberg M, Kestemont P. Effective and Safe Repeated Full-Face Treatments With AbobotulinumtoxinA, Hyaluronic Acid Filler, and Skin Boosting Hyaluronic Acid. J Drugs Dermatol. 2019 Jul 1;18(7):682-689.
PubMed 31334927
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluator-blinded Multi-center Study of Combined Treatment With Azzalure/Dysport, Restylane/Emervel Filler and Restylane Skinbooster as Compared to Single Treatment With Either Azzalure/Dysport Alone or Restylane/Emervel Filler Alone
- ClinicalTrials.gov ID
- NCT02297516
- Acronym / sponsor ID
- 05PDF1401
- Conditions
- Aesthetics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Nov 2014 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 21 Nov 2014 (estimated)
- Results
- Posted 30 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The efficacy and safety, as well as subject satisfaction will be evaluated after single treatment with Azzalure/Dysport alone or Restylane/Emervel filler alone followed by repeated combined treatment with Azzalure/Dysport, Restylane/Emervel filler and Restylane Skinbooster. Subjects will be followed for up to 18 months after initial treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Azzalure/Dysport as single treatment | Experimental | Drug: Azzalure or Dysport, Device: Restylane or Emervel filler, Device: Restylane SkinboosterAzzalure/Dysport as single treatment at initial treatment |
| Filler as single treatment | Experimental | Drug: Azzalure or Dysport, Device: Restylane or Emervel filler, Device: Restylane SkinboosterFiller as single treatment at initial treatment |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subjects aged 35 to 50 years old
- Subjects with the intention to undergo facial aesthetic treatment and who are likely to benefit from a combination of injection treatments and the benefit can be shown by improvements in their global facial aesthetic appearance and satisfaction.
- Subjects with nasolabial folds assessed as mild or moderate.
- Subjects with upper facial lines to be treated (at least two of glabellar lines, crow´s feet and/or forehead lines) assessed as moderate or severe, when the severity of the lines has an important psychological impact on the subject.
- Subjects with signed informed consent.
Key exclusion criteria (17 listed)
- Obvious facial sagging (major loss of facial fat/volume).
- Signs or symptoms of eyelid ptosis or signs of compensatory frontalis muscle activity.
- Heavily scarred or sun-damaged facial skin.
- Active skin disease, inflammation or related conditions, such as infection, psoriasis and herpes zoster/herpes simplex near or on the areas to be treated.
- Cancerous or pre-cancerous lesions in the areas to be treated.
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 |
|---|---|---|
| Azzalure or DysportAlso: Botulinum toxinGlabellar lines | Drug | Azzalure/Dysport as single treatment, Filler as single treatment |
| Restylane or Emervel fillerAlso: Hyaluronic acidFacial tissue augmentation | Device | Azzalure/Dysport as single treatment, Filler as single treatment |
| Restylane SkinboosterAlso: Hyaluronic acidFacial skin rejuvenation | Device | Azzalure/Dysport as single treatment, Filler as single treatment |
Primary outcome
Percentage of Subjects With Improvement in Global Facial Aesthetic Appearance
Time frame: 7 months
Percentage of subjects showing superior global facial aesthetic appearance at month 7 compared to month 1. Assessment of global facial aesthetic appearance was based on blinded evaluations of subject's youthful appearance (e.g. lack of facial volume loss, lack of static wrinkles and fine lines, good skin quality, and satisfactory result after aesthetic treatment). The blinded evaluators retrospectively reviewed photographs from visit for each subject and answered the following question: "At which set of photographs does the subject show superior global facial aesthetic appearance?".
6 secondary outcomes
Percentage of Subjects With Improvement in Global Facial Aesthetic Appearance
Time frame: 1, 7 and 13 months
Number of Subjects Improved on the Global Aesthetic Improvement Scale (GAIS) as Assessed by Blinded Evaluator
Time frame: 1, 7, and 13 months
Number of Participants Satisfied With Facial Appearance
Time frame: 7 and 13 months
Number of Participants for Which the Investigator is Satisfied With the Outcome
Time frame: 7 and 13 months
Percentage of Subjects Improved in Wrinkle Severity Score
Time frame: 7 and 13 months
Injected Volume of Study Products at Initial Single Treatment
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 31334927Heden P, Hexsel D, Cartier H, Bergentz P, Delmar H, Camozzato F, Siega C, Skoglund C, Edwartz C, Norberg M, Kestemont P. Effective and Safe Repeated Full-Face Treatments With AbobotulinumtoxinA, Hyaluronic Acid Filler, and Skin Boosting Hyaluronic Acid. J Drugs Dermatol. 2019 Jul 1;18(7):682-689.
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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.
Philippe Kestemont, MD principal investigator
Clinique Science et Beauté, Antibes, France
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Azzalure or Dysport, Restylane or Emervel filler and Restylane Skinbooster in people with Aesthetics, run by Galderma R&D at 4 sites in 3 countries.
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 5 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: finished, as of the sponsor's last update on 14 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France, Brazil, Sweden. 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 30 Sep 2019). 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 Improvement in Global Facial Aesthetic Appearance (time frame: 7 months). 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 NCT02297516, 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 14 Oct 2022.