Safety and Efficacy of Azzalure/Dysport, Restylane/Emervel Filler and Restylane Skinbooster Treatment

Galderma

Status and phase

Completed

Phase 4

Conditions

Aesthetics

Treatments

Device: Restylane Skinbooster

Drug: Azzalure or Dysport

Device: Restylane or Emervel filler

Study type

Interventional

Funder types

Industry

Identifiers

NCT02297516

05PDF1401

Details and patient eligibility

About

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.

Enrollment

65 patients

Sex

All

Ages

35 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.