Mode
Text Size
Log in / Sign up
Phase 4 N=61 Randomized Treatment

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

Facial Aesthetic Treatment

Enrolled (actual)
61
Serious AEs
0.6%
Results posted
Sep 2019
Primary outcome: Primary: Number of Subjects With Improvement in Global Facial Aesthetic Appearance at 7 Months (Review of Photographs) — 20; 25 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Azzalure (Drug); Restylane/Emervel filler (Device); Restylane Skinbooster (Device)
Age
Adult · 35+ yrs
Sex
All
Sponsor
Galderma R&D
Primary completion
Dec 2016

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Subjects With Improvement in Global Facial Aesthetic Appearance at 7 Months (Review of Photographs)
20; 25
SECONDARY
Number of Subjects With Improvement in Global Facial Aesthetic Appearance at 1, 7 and 13 Months (Review of Photographs)
5; 0; 5; 11; 13; 14
SECONDARY
Number of Participants Improved on the Global Aesthetic Improvement Scale (GAIS) as Assessed by Blinded Evaluator
35; 42; 47
SECONDARY
Number of Subjects Satisfied With Overall Facial Appearance (Questionnaire)
23; 26; 24; 27
SECONDARY
Number of Subjects for Which the Investigator is Satisfied With Overall Facial Aesthetic Outcome
28; 28; 28; 28
SECONDARY
Number of Participants Who Had Improvement in Wrinkle Severity Score of Treated Glabellar Lines (Validated Photo Scales)
27; 28; 27; 28
SECONDARY
Change in Perceived Age of Subjects
-1.7; -1.9; -1.9; -2.4
SECONDARY
Injected Filler Volume
0.98; 1.92; 1.72
SECONDARY
Adverse Event Reporting
36; 26

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.

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02297503). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search