Safety and efficacy of repeated facial aesthetic treatment
Research type
Research Study
Full 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
IRAS ID
155252
Contact name
Cecilia Skoglund
Contact email
Sponsor organisation
Q-Med AB
Eudract number
2014-001203-50
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
Many patients undergo facial aesthetic treatment with botulinum toxin (e.g Azzalure), dermal fillers (e.g Restylane and Emervel fillers) and products improving the skin quality (e.g Restylane skinbooster) repeatedly according to a treatment plan.
This is a post-marketing multi-centre study to evaluate the safety and efficacy of one single treatment using either Azzalure alone or Restylane/Emervel filler alone, followed by 2 combined treatments using several products (Azzalure, filler and Restylane skinbooster). All products to be used in the study are commercial products and will be used according to approved treatment areas, volumes and doses.
Approximately 60 subjects aged 35-50 years old with the intention to undergo facial aesthetic treatment of glabellar lines, NLFs and/or cheeks and facial skin rejuvenation will be asked to participate in the study. It is expected that 15 subjects will take part in the study at 1 UK site.
Subjects will be randomised 1:1 to either Group A or Group B. The only difference between the two groups is the assignment of single treatment at baseline. Both groups will receive the same combined treatments at 6 months and 12 months thereafter. All subjects will be followed for 18 months and will visit the clinic 13-14 times during this period.Global aesthetic improvement compared to pre-treatment photographs will be assessed by the subject, the investigator and by blinded evaluation. Superior global facial aesthetic appearance, first impression and perceived age of subjects will be assessed by blinded evaluation of photographs. Wrinkle severity scores of glabellar lines will be evaluated by the investigator. Subject and investigator satisfaction will be evaluated by questionnaires. Filler volume injected in NLFs and cheeks will be evaluated at each treatment session. Comparisons will be made within Group A and Group B, not between groups.
Safety will be followed by adverse event reporting throughout the study.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
14/EE/1199
Date of REC Opinion
3 Nov 2014
REC opinion
Unfavourable Opinion