Status:
COMPLETED
Safety and Efficacy of Azzalure/Dysport, Restylane/Emervel Filler and Restylane Skinbooster Treatment
Lead Sponsor:
Galderma R&D
Conditions:
Aesthetics
Eligibility:
All Genders
35-50 years
Phase:
PHASE4
Brief 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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2017
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT02297516
Start Date
November 1 2014
End Date
March 1 2017
Last Update
October 14 2022
Active Locations (4)
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1
Brazilian Center for Studies in Dermatology
Porto Alegre, Brazil, 90570-040
2
Mediti Center
Paris, Antibes, France, 06160
3
Centre Medical Saint-Jean
Arras, France, 62000
4
Akademikliniken
Stockholm, Sweden, 115 42