Subjects with the intention to undergo facial aesthetic treatment and who are likely to benefit from a combination of injection treatments
Conditions
Sponsors
Q-med AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects aged 35 to 50 years old 2. 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 3. Subjects with nasolabial folds assessed as mild or moderate 4. Subjects with glabellar lines assessed as moderate or severe, when the severity of the lines has an important psychological impact on the subject 5. Subjects with signed informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Current facial conditions 1. Subjects requiring treatment of forehead lines or crow´s feet 2. Obvious facial sagging (major loss of facial fat/volume) 3. Signs or symptoms of eyelid ptosis or signs of compensatory frontalis muscle activity 4. Heavily scarred or sun-damaged facial skin 5. Active skin disease, inflammation or related conditions, such as infection, psoriasis and herpes zoster near or on the areas to be treated 6. Cancerous or pre-cancerous lesions in the areas to be treated Previous facial/dermatological procedures 7. Facial tissue augmenting therapy or revitalization treatment with hyaluronic acid (HA) or collagen, or botulinum toxin treatment during the last 12 months 8. Procedures or treatments inducing an active dermal response such as laser, Intense Pulsed Light, chemical peeling, microdermabrasion, retinoids within the last 6 months 9. Any aesthetic surgery of the face 10. Permanent implant or aesthetic treatment with non-HA or non-collagen products in the face Medical history and current health/medications 11. History of severe keloids and/or hypertrophic scars 12. Neuromuscular junctional disorders (e.g. myasthenia gravis, Eaton Lambert syndrome or amyotrophic lateral sclerosis) or history of dysphagia and aspiration 13. Known hypersensitivity to hyaluronic acid, botulinum toxin, lidocaine hydrochloride or other amide-type anesthetics 14. History of autoimmune diseases 15. 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) 16. 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 17. Immunosuppressive therapy, chemotherapy, or systemic corticosteroids within the last 3 months prior to baseline visit. 18. Female subjects who are pregnant or plan to become pregnant within the study timeframe, or who are nursing. Other 19. Participation in any other clinical study within 30 days prior to inclusion 20. Other condition preventing the subject to entering the study in the Investigator’s opinion e.g. subjects not likely to avoid other facial procedures that might interfere with the outcome of the study, subjects anticipated to be unreliable or incapable of understanding the study assessment or unrealistic expectations of treatment result 21. Study site staff or close relative to study site staff (e.g. parents, children, siblings or spouse) and employees at the sponsor company or close relatives to employees at the sponsor company
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate if superior global facial aesthetic appearance can be achieved by combined treatment with Azzalure, Restylane/Emervel filler and Restylane skinbooster compared to single treatment with either Azzalure or Restylane/Emervel filler alone;Secondary Objective: • If superior global facial aesthetic appearance is achieved at 1 month after single treatment, at 1 month after first combined treatment or at 1 month after a second combined treatment • GAIS (global aesthetic improvement scale) score assessment • First impression and perceived age assessment at baseline and at 1 month after single treatment, 1 month after first combined treatment, and at 1 month after a second combined treatment • GAIS score assessment by subject and investigator at follow-up • Subject satisfaction at baseline and at follow-up • Investigator satisfaction at follow-up • Photonumeric grading scale (Merz scales) scores assessment by the investigator of glabellar lines (at rest and at maximum frown) at baseline and at follow-up • Injected filler volume of nasolabial folds (NLFs) and/or cheeks at each treatment session • Safety by assessment of adverse events (AEs) throughout the study period;Primary end point(s): The primary objective of this study is to evaluate if subjects have superior global facial aesthetic appearance at 1 month after 1st combined treatment compared to at 1 month after single treatment, as assessed by blinded evaluation of photographs. The proportion of subjects where the 1st combined treatment will show superior global facial appearance than the single treatment will be calculated together with a 95 % confidence interval. The primary objective is to show that the interval lay above 50%.;Timepoint(s) of evaluation of this end point: 18 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • “Global facial aesthetic appearance” assessed at 1, 7 and 13 months • GAIS (global aesthetic improvement) score at 1, 7 and 13 months compared to baseline • First impression and perceived age of subjects assessed at 1, 7 and 13 months • GAIS score assessed by subject and treating investigator at follow-up visits (1, 3, 6, 7, 9, 12, 13, 15 and 18 months) • Subject satisfaction assessed at baseline and at follow-up visits (0, 1, 3, 6, 7, 9, 12, 13, 15 and 18 months). • Investigator satisfaction assessed at follow-up visits (1, 7, 12, 13 and 18 months) • Wrinkle severity score of treated glabellar lines (at rest and at maximum frown) assessed by the treating investigator at baseline and at follow-up visits (0, 1, 3, 6, 7, 9, 12, 13, 15 and 18 months) • Injected filler volume of nasolabial folds and/or cheeks will be documented by the investigator at each treatment session;Timepoint(s) of evaluation of this end point: 18 months | — |
Countries
Sweden
Contacts
Public ContactClinical Operations
TFS Trial Form Support AB
Outcome results
None listed