Phase 4
N=61
Safety and Efficacy of Treatment With Azzalure, Restylane/Emervel Filler and Restylane Skinbooster
Facial Aesthetic Treatment
Bottom Line
View on ClinicalTrials.gov: NCT02297503 ↗Enrolled (actual)
61
Serious AEs
0.6%
Results posted
Sep 2019
Primary outcome: Primary: Number of Subjects With Improvement in Global Facial Aesthetic Appearance at 7 Months (Review of Photographs) — 20; 25 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Azzalure (Drug); Restylane/Emervel filler (Device); Restylane Skinbooster (Device)
- Age
- Adult · 35+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Improvement in Global Facial Aesthetic Appearance at 7 Months (Review of Photographs) |
20; 25 | — |
| SECONDARY Number of Subjects With Improvement in Global Facial Aesthetic Appearance at 1, 7 and 13 Months (Review of Photographs) |
5; 0; 5; 11; 13; 14 | — |
| SECONDARY Number of Participants Improved on the Global Aesthetic Improvement Scale (GAIS) as Assessed by Blinded Evaluator |
35; 42; 47 | — |
| SECONDARY Number of Subjects Satisfied With Overall Facial Appearance (Questionnaire) |
23; 26; 24; 27 | — |
| SECONDARY Number of Subjects for Which the Investigator is Satisfied With Overall Facial Aesthetic Outcome |
28; 28; 28; 28 | — |
| SECONDARY Number of Participants Who Had Improvement in Wrinkle Severity Score of Treated Glabellar Lines (Validated Photo Scales) |
27; 28; 27; 28 | — |
| SECONDARY Change in Perceived Age of Subjects |
-1.7; -1.9; -1.9; -2.4 | — |
| SECONDARY Injected Filler Volume |
0.98; 1.92; 1.72 | — |
| SECONDARY Adverse Event Reporting |
36; 26 | — |
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. 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 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.
Exclusion Criteria
- 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.
- 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 (NCT02297503). 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.