Facial Aesthetic TreatmentPhase 4NCT02297503
Safety and Efficacy of Treatment With Azzalure, Restylane/Emervel Filler and Restylane Skinbooster
A Phase 4 study testing Azzalure, Restylane/Emervel filler and Restylane Skinbooster in people with Facial Aesthetic Treatment, run by Galderma R&D at 3 sites in 2 countries.
Trial summary
The efficacy and safety, as well as subject satisfaction will be evaluated after single treatment with Azzalure alone or Restylane/Emervel filler alone followed by repeated combined treatment with Azzalure, 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
- Facial Aesthetic Treatment
- What is being tested?
- Azzalure, Restylane/Emervel filler and Restylane Skinbooster
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Nov 2014to Dec 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 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 glabellar 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
- Subjects requiring treatment of forehead lines or crow´s feet.
- 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.
Show all 18Show fewer
- Facial tissue augmenting therapy or revitalization treatment with hyaluronic acid (HA) or collagen, or botulinum toxin treatment during the last 12 months.
- 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
3 sites in 2 countries.
3 sites in 2 countries
France2 sites
Centre Medical Saint-Jean
Arras, 62000
Mediti Center
Paris, Antibes, 06160
About this study
Official title: An Evaluator-blinded Multi-center Study of Combined Treatment With Azzalure, Restylane/Emervel Filler and Restylane Skinbooster as Compared to Single Treatment With Either Azzalure Alone or Restylane/Emervel Filler Alone
The efficacy and safety, as well as subject satisfaction will be evaluated after single treatment with Azzalure alone or Restylane/Emervel filler alone followed by repeated combined treatment with Azzalure, Restylane/Emervel filler and Restylane Skinbooster. Subjects will be followed for up to 18 months after initial treatment.
- Conditions
- Facial Aesthetic Treatment
- Being tested
- Azzalure, Restylane/Emervel filler, Restylane Skinbooster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzzalureDrug
Also called Botulinum toxin
Glabellar lines
Restylane/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 alone as single treatment | Experimental | Azzalure alone as single treatment at initial treatment followed by two combined treatments with Azzalure, HA filler and Skinboosters at Month 6 and Month 12. Receives: Drug: Azzalure; Device: Restylane/Emervel filler; Device: Restylane Skinbooster |
| Filler alone as single treatment | Experimental | HA filler alone as single treatment at initial treatment followed by two combined treatments with Azzalure, HA filler and Skinboosters at Month 6 and Month 12. Receives: Drug: Azzalure; Device: Restylane/Emervel filler; Device: Restylane Skinbooster |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Improvement in Global Facial Aesthetic Appearance at 7 Months (Review of Photographs)
To evaluate "Global facial aesthetic appearance" at 7 months compared to at 1 month, blinded evaluator review of photographs.
Measured: 7 months
Secondary outcomes (8)
Number of Subjects With Improvement in Global Facial Aesthetic Appearance at 1, 7 and 13 Months (Review of Photographs)
To evaluate "Global facial aesthetic appearance" at 1, 7 and 13 months, blinded evaluator review of photographs from the respective visits.
Measured: 1, 7 and 13 months
Number of Participants Improved on the Global Aesthetic Improvement Scale (GAIS) as Assessed by Blinded Evaluator
The 5-graded GAIS is 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 scale grades are Very much improved, Much improved, Somewhat improved, No change, Worse. Improved subjects are those graded as Very much improved, Much improved, and Somewhat improved.
Measured: Month 1, Month 7, and Month 13
Number of Subjects Satisfied With Overall Facial Appearance (Questionnaire)
Subjects answered the question "How satisfied are you today with the appearance of your face?" with "Very/somewhat satisfied", "Neither/nor", or "Very/somewhat dissatisfied". Number of subjects satisfied are those that answered "Very/somewhat satisfied".
Measured: Month 7 and Month 13
Number of Subjects for Which the Investigator is Satisfied With Overall Facial Aesthetic Outcome
The Investigator 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 is met for those subjects that the Investigator answered "Very/somewhat satisfied".
Measured: Month 7 and Month 13
Number of Participants Who Had Improvement in Wrinkle Severity Score of Treated Glabellar Lines (Validated Photo Scales)
The wrinkle severity of the glabellar lines at maximum frown was evaluated by the investigator at baseline before first treatment and at follow-up visits. Validated photonumeric grading scales were used where each severity grade is illustrated by a set of photographs. The investigator performed the assessment live or by using 2D photographs from the present visit, together with the respective photo guide: 0 No glabella lines, 1 Mild glabella lines, 2 Moderate glabella lines, 3 Severe glabella lines, 4 Very severe glabella lines. Improved criteria is thus fulfilled for subjects receiving a lower score compared to baseline.
Measured: Month 7 and Month 13
Change in Perceived Age of Subjects
To evaluate First impression and perceived age of subjects by evaluation of photos.
Change between timepoints are reported. A negative value indicates that the participant is assessed to be younger at the specified visit compared to the assessment made at 1 month after single treatment.
Measured: 1 and 7 months, and 1 and 13 months
Injected Filler Volume
To evaluate the filler volume injected at initial single treatment and at following repeated combined treatment
Measured: Initial single treatment (baseline), first combined treatment (Month 6), and second combined treatment (Month 12)
Adverse Event Reporting
To evaluate safety throughout the study period
Measured: 0-18 months
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 completionDec 2016
- Study completionDec 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 Facial Aesthetic TreatmentStudies 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
- 61 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
- NCT02297503
- Sponsor's protocol ID
- 05DF1211
- Status last verified
- Aug 2019
- First submitted
- 31 Oct 2014
- Last updated
- 26 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 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, Restylane/Emervel Filler and Restylane Skinbooster as Compared to Single Treatment With Either Azzalure Alone or Restylane/Emervel Filler Alone
- ClinicalTrials.gov ID
- NCT02297503
- Acronym / sponsor ID
- 05DF1211
- Conditions
- Facial Aesthetic Treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Nov 2014 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 21 Nov 2014 (estimated)
- Results
- Posted 23 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 alone or Restylane/Emervel filler alone followed by repeated combined treatment with Azzalure, 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 alone as single treatment | Experimental | Drug: Azzalure, Device: Restylane/Emervel filler, Device: Restylane SkinboosterAzzalure alone as single treatment at initial treatment followed by two combined treatments with Azzalure, HA filler and Skinboosters at Month 6 and Month 12. |
| Filler alone as single treatment | Experimental | Drug: Azzalure, Device: Restylane/Emervel filler, Device: Restylane SkinboosterHA filler alone as single treatment at initial treatment followed by two combined treatments with Azzalure, HA filler and Skinboosters at Month 6 and Month 12. |
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 glabellar 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 (18 listed)
- Subjects requiring treatment of forehead lines or crow´s feet.
- 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.
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 |
|---|---|---|
| AzzalureAlso: Botulinum toxinGlabellar lines | Drug | Azzalure alone as single treatment, Filler alone as single treatment |
| Restylane/Emervel fillerAlso: Hyaluronic acidFacial tissue augmentation | Device | Azzalure alone as single treatment, Filler alone as single treatment |
| Restylane SkinboosterAlso: Hyaluronic acidFacial skin rejuvenation | Device | Azzalure alone as single treatment, Filler alone as single treatment |
Primary outcome
Number of Subjects With Improvement in Global Facial Aesthetic Appearance at 7 Months (Review of Photographs)
Time frame: 7 months
To evaluate "Global facial aesthetic appearance" at 7 months compared to at 1 month, blinded evaluator review of photographs.
8 secondary outcomes
Number of Subjects With Improvement in Global Facial Aesthetic Appearance at 1, 7 and 13 Months (Review of Photographs)
Time frame: 1, 7 and 13 months
Number of Participants Improved on the Global Aesthetic Improvement Scale (GAIS) as Assessed by Blinded Evaluator
Time frame: Month 1, Month 7, and Month 13
Number of Subjects Satisfied With Overall Facial Appearance (Questionnaire)
Time frame: Month 7 and Month 13
Number of Subjects for Which the Investigator is Satisfied With Overall Facial Aesthetic Outcome
Time frame: Month 7 and Month 13
Number of Participants Who Had Improvement in Wrinkle Severity Score of Treated Glabellar Lines (Validated Photo Scales)
Time frame: Month 7 and Month 13
Change in Perceived Age of Subjects
Time frame: 1 and 7 months, and 1 and 13 months
Injected Filler Volume
Time frame: Initial single treatment (baseline), first combined treatment (Month 6), and second combined treatment (Month 12)
Adverse Event Reporting
Time frame: 0-18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Azzalure, Restylane/Emervel filler and Restylane Skinbooster in people with Facial Aesthetic Treatment, run by Galderma R&D at 3 sites in 2 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 18 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 26 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 France, 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 23 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?
Number of Subjects With Improvement in Global Facial Aesthetic Appearance at 7 Months (Review of Photographs) (time frame: 7 months). 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 26 Aug 2022.