An study to compare combined treatment with Azzalure/Dysport, Restylane/Emervel filler and Restylane skinbooster with single treatment with either Azzalure/Dysport alone or Restylane/Emervel filler alone

Phase 1

• Conditions: Subjects with the intention to undergo facial aesthetic treatment and who are likely to benefit from a combination of injection treatments; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2014-001202-17-SE
• Lead Sponsor: Q-med AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05-20
• Last Update Posted: 12 March 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

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

Current facial conditions
1. Obvious facial sagging (major loss of facial fat/volume)
2. Signs or symptoms of eyelid ptosis or signs of compensatory frontalis muscle activity
3. 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
5. Cancerous or pre-cancerous lesions in the areas to be treated

Previous facial/dermatological procedures
6. Facial tissue augmenting therapy or revitalization treatment with hyaluronic acid (HA) or collagen, or botulinum toxin treatment during the last 12 months
7. Procedures or treatments inducing an active dermal response such as laser, Intense Pulsed Light, chemical peeling, microdermabrasion, retinoids within the last 6 months
8. Any aesthetic surgery of the face
9. Permanent implant or aesthetic treatment with non-HA or non-collagen products in the face

Medical history and current health/medications
10. History of severe keloids and/or hypertrophic scars
11. Neuromuscular junctional disorders (e.g. myasthenia gravis, Eaton Lambert syndrome or amyotrophic lateral sclerosis) or history of dysphagia and aspiration
12. Known hypersensitivity to hyaluronic acid, botulinum toxin, lidocaine hydrochloride or other amide-type anesthetics
13. History of autoimmune diseases
14. 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)
15. 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
16. Immunosuppressive therapy, chemotherapy, or systemic corticosteroids within the last 3 months prior to baseline visit.
17. Female subjects who are pregnant or plan to become pregnant within the study timeframe, or who are nursing.

Other
18. Participation in any other clinical study within 30 days prior to inclusion
19. 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
20. 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified