Clinical trial NCT02297503: Safety and Efficacy of Treatment With Azzalure, Restylane/Emervel Filler and Restylane Skinbooster
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Facial Aesthetic Treatment
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2014-11-21
Enrollment: 61
Sex: ALL
Minimum age (years): 35
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Number of Subjects With Improvement in Global Facial Aesthetic Appearance at 7 Months (Review of Photographs)
timeFrame: 7 months
Secondary outcomes:
measure: Number of Subjects With Improvement in Global Facial Aesthetic Appearance at 1, 7 and 13 Months (Review of Photographs)
timeFrame: 1, 7 and 13 months
measure: Number of Participants Improved on the Global Aesthetic Improvement Scale (GAIS) as Assessed by Blinded Evaluator
timeFrame: Month 1, Month 7, and Month 13
measure: Number of Subjects Satisfied With Overall Facial Appearance (Questionnaire)
timeFrame: Month 7 and Month 13
measure: Number of Subjects for Which the Investigator is Satisfied With Overall Facial Aesthetic Outcome
timeFrame: Month 7 and Month 13
measure: Number of Participants Who Had Improvement in Wrinkle Severity Score of Treated Glabellar Lines (Validated Photo Scales)
timeFrame: Month 7 and Month 13
measure: Change in Perceived Age of Subjects
timeFrame: 1 and 7 months, and 1 and 13 months
measure: Injected Filler Volume
timeFrame: Initial single treatment (baseline), first combined treatment (Month 6), and second combined treatment (Month 12)
measure: Adverse Event Reporting
timeFrame: 0-18 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Mediti Center
state: Antibes
city: Arras
country: France
facility: Centre Medical Saint-Jean
city: Stockholm
country: Sweden
facility: Akademikliniken
Study officials:
affiliation: Clinique Science et Beauté, Antibes, France
name: Philippe Kestemont, MD
role: PRINCIPAL_INVESTIGATOR
References: