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

NCT ID: NCT02297516

Last Updated: 2022-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2017-03-31

Brief 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.

Conditions

Aesthetics

Study Design

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

Study Groups

Azzalure/Dysport as single treatment

Azzalure/Dysport as single treatment at initial treatment

Group Type: EXPERIMENTAL

Azzalure or Dysport

Intervention Type: DRUG

Glabellar lines

Restylane or Emervel filler

Intervention Type: DEVICE

Facial tissue augmentation

Restylane Skinbooster

Intervention Type: DEVICE

Facial skin rejuvenation

Filler as single treatment

Filler as single treatment at initial treatment

Group Type: EXPERIMENTAL

Azzalure or Dysport

Intervention Type: DRUG

Glabellar lines

Restylane or Emervel filler

Intervention Type: DEVICE

Facial tissue augmentation

Restylane Skinbooster

Intervention Type: DEVICE

Facial skin rejuvenation

Interventions

Azzalure or Dysport

Glabellar lines

Intervention Type: DRUG

Restylane or 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 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.

• 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

Brazilian Center for Studies in Dermatology

Porto Alegre, , Brazil

Mediti Center

Paris, Antibes, France

Centre Medical Saint-Jean

Arras, , France

Akademikliniken

Stockholm, , Sweden

Countries

Brazil; France; Sweden

References

Heden P, Hexsel D, Cartier H, Bergentz P, Delmar H, Camozzato F, Siega C, Skoglund C, Edwartz C, Norberg M, Kestemont P. Effective and Safe Repeated Full-Face Treatments With AbobotulinumtoxinA, Hyaluronic Acid Filler, and Skin Boosting Hyaluronic Acid. J Drugs Dermatol. 2019 Jul 1;18(7):682-689.

Reference Type: RESULT

PMID: 31334927 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

05PDF1401

Identifier Type: -

Identifier Source: org_study_id