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

NCT ID: NCT02297503

Last Updated: 2022-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2016-12-31

Brief Summary

The efficacy and safety, as well as subject satisfaction will be evaluated after single treatment with Azzalure alone or Restylane/Emervel filler alone followed by repeated combined treatment with Azzalure, Restylane/Emervel filler and Restylane Skinbooster. Subjects will be followed for up to 18 months after initial treatment.

Conditions

Facial Aesthetic Treatment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Azzalure alone as single treatment

Azzalure alone as single treatment at initial treatment followed by two combined treatments with Azzalure, HA filler and Skinboosters at Month 6 and Month 12.

Group Type: EXPERIMENTAL

Azzalure

Intervention Type: DRUG

Glabellar lines

Restylane/Emervel filler

Intervention Type: DEVICE

Facial tissue augmentation

Restylane Skinbooster

Intervention Type: DEVICE

Facial skin rejuvenation

Filler alone as single treatment

HA filler alone as single treatment at initial treatment followed by two combined treatments with Azzalure, HA filler and Skinboosters at Month 6 and Month 12.

Group Type: EXPERIMENTAL

Azzalure

Intervention Type: DRUG

Glabellar lines

Restylane/Emervel filler

Intervention Type: DEVICE

Facial tissue augmentation

Restylane Skinbooster

Intervention Type: DEVICE

Facial skin rejuvenation

Interventions

Azzalure

Glabellar lines

Intervention Type: DRUG

Restylane/Emervel filler

Facial tissue augmentation

Intervention Type: DEVICE

Restylane Skinbooster

Facial skin rejuvenation

Intervention Type: DEVICE

Other Intervention Names

Botulinum toxin; Hyaluronic acid; Hyaluronic acid

Eligibility 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 glabellar 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

• Subjects requiring treatment of forehead lines or crow´s feet.
• 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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Galderma R&D

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philippe Kestemont, MD

Role: PRINCIPAL_INVESTIGATOR

Clinique Science et Beauté, Antibes, France

Locations

Mediti Center

Paris, Antibes, France

Centre Medical Saint-Jean

Arras, , France

Akademikliniken

Stockholm, , Sweden

Countries

France; Sweden

Other Identifiers

05DF1211

Identifier Type: -

Identifier Source: org_study_id