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

NCT02297516 | Completed Phase 4 Results

• 1 other identifier: 05PDF1401
• Study Type: interventional
• Target: 65
• Locations: 3 countries
• Sites: 4

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

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects With Improvement in Global Facial Aesthetic Appearance

  Percentage of subjects showing superior global facial aesthetic appearance at month 7 compared to month 1. Assessment of global facial aesthetic appearance was based on blinded evaluations of subject's youthful appearance (e.g. lack of facial volume loss, lack of static wrinkles and fine lines, good skin quality, and satisfactory result after aesthetic treatment). The blinded evaluators retrospectively reviewed photographs from visit for each subject and answered the following question: "At which set of photographs does the subject show superior global facial aesthetic appearance?".

  7 months

Secondary Outcomes (6)

• Percentage of Subjects With Improvement in Global Facial Aesthetic Appearance

  1, 7 and 13 months

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

  1, 7, and 13 months

• Number of Participants Satisfied With Facial Appearance

  7 and 13 months

• Number of Participants for Which the Investigator is Satisfied With the Outcome

  7 and 13 months

• Percentage of Subjects Improved in Wrinkle Severity Score

  7 and 13 months

Study Arms (2)

Azzalure/Dysport as single treatment

EXPERIMENTAL

Azzalure/Dysport as single treatment at initial treatment

Drug: Azzalure or Dysport; Device: Restylane or Emervel filler; Device: Restylane Skinbooster

Filler as single treatment

EXPERIMENTAL

Filler as single treatment at initial treatment

Drug: Azzalure or Dysport; Device: Restylane or Emervel filler; Device: Restylane Skinbooster

Interventions

Azzalure or Dysport DRUG

Glabellar lines

Also known as: Botulinum toxin

Azzalure/Dysport as single treatment; Filler as single treatment

Restylane or Emervel filler DEVICE

Facial tissue augmentation

Also known as: Hyaluronic acid

Azzalure/Dysport as single treatment; Filler as single treatment

Restylane Skinbooster DEVICE

Facial skin rejuvenation

Also known as: Hyaluronic acid

Azzalure/Dysport as single treatment; Filler 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 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.

You may not qualify if:

• 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.
• Immunosuppressive therapy, chemotherapy, or systemic corticosteroids within the last 3 months prior to baseline visit.

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (4)

Brazilian Center for Studies in Dermatology

Porto Alegre, 90570-040, Brazil

Location

Mediti Center

Paris, Antibes, 06160, France

Location

Centre Medical Saint-Jean

Arras, 62000, France

Location

Akademikliniken

Stockholm, 115 42, Sweden

Location

Related Publications (1)

• 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.

  PMID: 31334927 RESULT

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

Limitations and Caveats

Small number of subjects

Results Point of Contact

• Title: Head of Development
• Organization: Q-Med AB

reception.seupp@galderma.com

+ 46 (0) 18 474 90 00

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: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: October 14, 2022
• Results First Posted: September 30, 2019

Record last verified: 2019-09

Locations

FR (2); SE (1); BR (1)