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

• Status: Completed
• Trial end date: 2017-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Q-Med AB
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; Hyaluronic Acid; incobotulinumtoxinA; onabotulinumtoxinA

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.