Overview

This trial is active, not recruiting.

Condition facial aesthetic treatment
Treatments azzalure, restylane/emervel filler, restylane skinbooster
Phase phase 4
Sponsor Q-Med AB
Start date October 2014
End date September 2016
Trial size 60 participants
Trial identifier NCT02297503, 05DF1211

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Azzalure alone as single treatment at initial treatment
azzalure Botulinum toxin
Glabellar lines
restylane/emervel filler Hyaluronic acid
Facial tissue augmentation
restylane skinbooster Hyaluronic acid
Facial skin rejuvenation
(Experimental)
Filler alone as single treatment at initial treatment
azzalure Botulinum toxin
Glabellar lines
restylane/emervel filler Hyaluronic acid
Facial tissue augmentation
restylane skinbooster Hyaluronic acid
Facial skin rejuvenation

Primary Outcomes

Measure
"Global facial aesthetic appearance" at 7 months (eview of photographs)
time frame: 7 months

Secondary Outcomes

Measure
"Global facial aesthetic appearance" at 1, 7 and 13 months (review of photographs)
time frame: 1, 7 and 13 months
Global Aesthetic Improvement Scale (GAIS)
time frame: 1 month to 18 months
Subject satisfaction (questionnaire)
time frame: 0-18 months
Investigator satisfaction (questionnaire)
time frame: 1-18 months
Wrinkle severity score of treated glabellar lines (validated photo scales)
time frame: 0-18 months
First impression and perceived age of subjects
time frame: 1, 7 and 13 months
Injected filler volume
time frame: 0-18 months
Adverse Event reporting
time frame: 0-18 months

Eligibility Criteria

Male or female participants from 35 years up to 50 years old.

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.

Additional Information

Official title An Evaluator-blinded Multi-center Study of Combined Treatment With Azzalure, Restylane/Emervel Filler and Restylane Skinbooster as Compared to Single Treatment With Either Azzalure Alone or Restylane/Emervel Filler Alone
Principal investigator Philippe Kestemont, MD
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Q-Med AB.