Azzalure, 2 fillers & Restylane booster compared to Azzalure alone
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
Ravi Jain
Contact email
Sponsor organisation
Q-Med AB
Eudract number
2014-001203-50
Research summary
In this study subjects are being asked to take part in this study because they have the intention to undergo facial aesthetic treatment including correction of facial wrinkles or volume loss and improvement of the skin quality of their face.
The objectives of this study is to evaluate if superior global facial aesthetic appearance can be achieved by combined treatment compared to single treatment. Treatment result will be assessed by blinded evaluation of photographs. Treatment will consist of a single treatment of either Azzalure alone or Restylane/Emervel filler alone. ?Combined treatment consists of Azzalure, Restylane/Emervel filler and Restylane skinbooster.
The study will involve in total about 60 subjects at 4-6 clinics in Sweden, France and United Kingdom. It is expected that 20 subjects will take part in the study at 1 UK site. Subjects will be required to visit the clinic 13-14 times during an 18 month period.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
14/EE/1031
Date of REC Opinion
24 Jul 2014
REC opinion
Unfavourable Opinion