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

NCT02297503 | Completed Phase 4 Results

• 1 other identifier: 05DF1211
• Study Type: interventional
• Target: 61
• Locations: 2 countries
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Improvement in Global Facial Aesthetic Appearance at 7 Months (Review of Photographs)

  To evaluate "Global facial aesthetic appearance" at 7 months compared to at 1 month, blinded evaluator review of photographs.

  7 months

Secondary Outcomes (8)

• Number of Subjects With Improvement in Global Facial Aesthetic Appearance at 1, 7 and 13 Months (Review of Photographs)

  1, 7 and 13 months

• Number of Participants Improved on the Global Aesthetic Improvement Scale (GAIS) as Assessed by Blinded Evaluator

  Month 1, Month 7, and Month 13

• Number of Subjects Satisfied With Overall Facial Appearance (Questionnaire)

  Month 7 and Month 13

• Number of Subjects for Which the Investigator is Satisfied With Overall Facial Aesthetic Outcome

  Month 7 and Month 13

• Number of Participants Who Had Improvement in Wrinkle Severity Score of Treated Glabellar Lines (Validated Photo Scales)

  Month 7 and Month 13

Study Arms (2)

Azzalure alone as single treatment

EXPERIMENTAL

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.

Drug: Azzalure; Device: Restylane/Emervel filler; Device: Restylane Skinbooster

Filler alone as single treatment

EXPERIMENTAL

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.

Drug: Azzalure; Device: Restylane/Emervel filler; Device: Restylane Skinbooster

Interventions

Azzalure DRUG

Glabellar lines

Also known as: Botulinum toxin

Azzalure alone as single treatment; Filler alone as single treatment

Restylane/Emervel filler DEVICE

Facial tissue augmentation

Also known as: Hyaluronic acid

Azzalure alone as single treatment; Filler alone as single treatment

Restylane Skinbooster DEVICE

Facial skin rejuvenation

Also known as: Hyaluronic acid

Azzalure alone as single treatment; Filler alone as single treatment

Eligibility Criteria

• Age: 35 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (3)

Mediti Center

Paris, Antibes, 06160, France

Location

Centre Medical Saint-Jean

Arras, 62000, France

Location

Akademikliniken

Stockholm, 115 42, Sweden

Location

MeSH Terms

Interventions

abobotulinumtoxinA; Botulinum Toxins

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Results Point of Contact

• Title: Maria Norberg
• Organization: Galderma

maria.norberg@galderma.com

+46184891267

Study Officials

• Philippe Kestemont, MD

  Clinique Science et Beauté, Antibes, France

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2014
• First Posted: November 21, 2014
• Study Start: November 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: August 26, 2022
• Results First Posted: September 23, 2019

Record last verified: 2019-08

Locations

FR (2); SE (1)