Phase 4
N=65
Safety and Efficacy of Azzalure/Dysport, Restylane/Emervel Filler and Restylane Skinbooster Treatment
Aesthetics
Bottom Line
View on ClinicalTrials.gov: NCT02297516 ↗Enrolled (actual)
65
Serious AEs
0.5%
Results posted
Sep 2019
Primary outcome: Primary: Percentage of Subjects With Improvement in Global Facial Aesthetic Appearance — 66.7; 93.5 percentage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Azzalure or Dysport (Drug); Restylane or Emervel filler (Device); Restylane Skinbooster (Device)
- Age
- Adult · 35+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With Improvement in Global Facial Aesthetic Appearance |
4.0; 3.6; 36.0; 35.7; 60.0; 60.7 | — |
| SECONDARY Percentage of Subjects With Improvement in Global Facial Aesthetic Appearance |
4.0; 3.6; 36.0; 35.7; 60.0; 60.7 | — |
| SECONDARY Number of Subjects Improved on the Global Aesthetic Improvement Scale (GAIS) as Assessed by Blinded Evaluator |
65.1; 90.3; 88.3 | — |
| SECONDARY Number of Participants Satisfied With Facial Appearance |
31; 29; 30; 29 | — |
| SECONDARY Number of Participants for Which the Investigator is Satisfied With the Outcome |
31; 31; 30; 29 | — |
| SECONDARY Percentage of Subjects Improved in Wrinkle Severity Score |
100; 100; 100; 100 | — |
| SECONDARY Injected Volume of Study Products at Initial Single Treatment |
118.8; 0.99 | — |
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. Subjects will be followed for up to 18 months after initial treatment.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
- 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.
Data sourced from ClinicalTrials.gov (NCT02297516). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.